MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE DUALMESH BIOMATERIAL; MESH, SURGICAL, POLYMERIC

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Not Applicable (3189)

Event Date 05/13/2016

Event Type  Injury  

Manufacturer Narrative

Separate medwatch reports are being submitted for the alleged gore devices reportedly implanted on (b)(6) 2005, (b)(6) 2005, and (b)(6) 2006.(b)(6).(b)(4).It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.

Event Description

It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2005 whereby an alleged gore dualmesh® biomaterial was implanted.It was also reported that on (b)(6) 2005 and (b)(6) 2006 the patient underwent laparoscopic ventral hernia repairs whereby an alleged gore dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2016 an additional procedure was performed whereby explant of the gore devices was performed.It was reported the patient alleges the following injuries: adhesions to abdominal wall and small bowel, hernia recurrences, persistent pelvic and abdominal pain, additional surgeries for revision/removal of mesh.Additional event specific information and medical records have been requested.

Manufacturer Narrative

Other relevant history: added medical history.Conclusion code remains unchanged.Added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records between 10/4/2006 and 1/17/2013 were not provided.Medical records dated on (b)(6) 2013 state: ¿here for evaluation of left sided lower abdominal pain which started about 3 mos ago when mesh was surgically implanted to repair problems from hernia operations done in the past.The pain has been present intermittently since surgery but would only last up to 15 minutes; pain started today at noon and has been present ever since.¿ records dated on (b)(6) 2013 state: ¿had hernia repair by dr.(b)(6) and then subsequent rerepair with mesh by dr.(b)(6) in albany.When pt was having problems and went back to see dr.(b)(6) he was told in a very blunt manner "well we will just remove it then." pt chose not to follow up with him and has just put up with the discomfort.He is hesitant to take pain meds as they throw him for a loop.¿ the records state ¿ruq tenderness and rlq tenderness.¿ ¿no hernia palpable.¿ ct abdomen/pelvis dated on (b)(6) 2013 for history of abdominal pain states: ¿impression: no acute abnormality identified.¿ medical records dated on (b)(6) 2014 state: ¿chief complaint: pain on r side travels across stomach to l side has been worse x 2 weeks.Has diarrhea x l month.¿ physical exam: ¿abdomen: rlq tenderness.Inguinal (rt noted on the ct and tenderness with the exam however i can not feel).¿ ct abdomen/pelvis dated on (b)(6) 2014 for nonspecific abdominal pain states: ¿no acute abnormality seen.¿ pertinent records dated between on (b)(6) 2014 and on (b)(6) 2016 were not provided.Medical records dated on (b)(6) 2017 state patient was seen for chief complaint ¿bilateral groin pain.States he had hernia repair bilateral summer 2016.Had mesh installed.¿ ¿had bilateral hernias this past summer and had them repaired and additional mesh was placed.Pt had a previous abdominal hernia which the mesh had failed in and had to have the whole huge piece replaced.Has had discomfort into the inguinal regions bilaterally and into other areas of the mesh.No rash, nn/d.Has felt feverish on and off with chills.Concerned that maybe he has an infection.¿ the records dated on (b)(6) 2017 state: ¿will treat with doxy as directed x 14 days.Levaquin and cipro potentially interact with multiple meds.Doxy does not.Will give hydrocodone for prn use.Good scrotal support.Moist heat, nsaids prn.Doubt mesh failure.If no improvement or worse would order abdominal ct with iv and oral contrast.¿ medical records dated on (b)(6) 2017 state: ¿patient is here for evaluation of across entire mid abdominal wall which has been present for years but had gotten worse in the past month;¿ ¿pt continues to have abdominal pain in a squared off pattern c/w his mesh from his hernia repair.He had a ct in feb which showed a fatty rih but no disruption of the mesh.The surgeon wanted him to do 18 weeks of physical therapy 3 times a week at (b)(4) a visit which he can't afford to do.Pt thinks he may have an infection as he feels hot and his abdomen feels hot all the time.No documented fever.Pain on the left side feels like a knife stabbing him when he is seated.The other option was to have to mesh removed.He does not care for the surgeon as he has no bed side manner.He has alternatinq constipation and diarrhea due to his ibs.Has had to start usinq hydrocodone for the pain.Had colonoscopy in 2013 which did not show any diverticulosis.No blood in stool.¿ the records dated on (b)(6) 2017 state: ¿abdomen: bowel sounds: normal.Inspection and palpation: no masses, rebound tenderness, or cva tenderness and guarding, luq tenderness, ruq tenderness, llq tenderness, and rlq tenderness; c/w the borders of his mesh.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

H6: codes 4118/3221 product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.H6: conclusion code remains unchanged.

Manufacturer Narrative

H6: corrected conclusion code.H10/11: added medical record summary.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: records prior to 7/11/2005 were not provided, including any related to the ¿previously placed scar¿ referred to in operative records dated 7/11/2005.Operative records dated (b)(6) 2005 indicate the patient underwent ventral hernia repair with mesh.The records state: ¿the previously placed scar was excised, and the hernia sac entered.Adhesions of omentum and the hernia sac were taken down, and the omentum placed back into the abdominal cavity.Only minor adhesions were identified thereafter, but there were a few cicatrices around the small bowel which were divided.The small bowel was run and all adhesions were divided.Using interrupted #2 nylon and #1 prolene, the gap at both the upper and the lower end was partially closed and a 10x14 cm portion of impregnated dualmesh inserted and secured with interrupted #2 nylon sutures placed in such a fashion that the mesh overlapped the posterior edge of the anterior abdominal wall by at least 3 cm in all areas.In this fashion, the hernia was closed.The tissue immediately superior to the mesh was closed over it with a running 0 vicryl suture.¿ product identification records for the alleged gore device were not provided.Operative records dated (b)(6) 2005 indicate the patient underwent laparoscopic repair of recurrent ventral incisional hernia.The records state: ¿the patient is a 43-year-old gentleman who had undergone an exploratory laparotomy in march 2005.After the procedure, he developed a ventral hernia which was repaired using an open technique in july.The patient presented to the office complaining of persistent pain along the right lower abdomen, just adjacent to the mesh, extending down into the lower pelvis.Ct scan showed a small fascial defect, but no obvious recurrence of the hernia.¿ procedural findings state: ¿a small recurrent hernia was identified at the superior aspect of the incision over the previous mesh.In the area of the patient¿s most significant tenderness, in the right lower quadrant, there was no evidence of recurrent hernia or other obvious pathology to explain the patient¿s symptoms.¿ medical records for the exploratory laparotomy in march 2005 were not provided.The 11/10/2005 records continue: ¿small window was identified over the right upper quadrant and a 5 mm port was placed in the right upper quadrant after infiltrating with local anesthetic.Blunt dissection was then used to take down several adhesions of omentum to the undersurface of the previous mesh.¿ ¿this same procedure was performed on the left lower quadrant after freeing up several adhesions.Several loops of small bowel were noted to be loosely adherent to the mesh and were taken down using blunt dissection.When all adhesions had been completely removed, the mesh was examined and a small recurrent defect approximately 6 x 6 cm in diameter was noted at the superior aspect of the mesh.This was marked on the surface of the skin and a gore dual mesh was cut into oval fashion using an 8 x 10 cm mesh.Anchoring sutures were placed in four quadrants of o gore-tex.This was then rolled into a cigar shape.The 11/10/2005 records continue: ¿the left upper quadrant port was exchanged for a 10 mm port and the mesh was passed through this port.Using the gore needle-passer, the four stay sutures were brought up in four quadrants through small abdominal wall incisions.There were then tied to anchor the mesh.Four other sutures were passed through the abdominal wall through small incisions using a gore needle-passer to further anchor the mesh.The free edges of the mesh were clipped using the wire tacker.At this point, a small bulge was noted just to the right portion of the mesh, just above the umbilicus.This was not a definite fascial defect, but slight laxity was definitely noted.The mesh in this area was approximated to the healthy fascia using interrupted sutures of 0 gore-tex.This was performed using the gore needle-passer.At this point, hemostasis was noted to be complete.¿ product identification records for the alleged gore device were not provided.There was no mention of infection or removal of the gore device in the records.Operative records dated 10/4/2006 indicate the patient underwent laparoscopic ventral hernia repair for a 30 cm x 20 cm defect and lysis of adhesions.The records state: ¿this is a patient with a previous laparoscopic ventral hernia repair and open repairs times two.He has had recurrences of these hernias after each of these episodes.He has been unsuccessful with the hernia repairs and now comes in with a recurrent hernia.¿ the 10/4/2006 records state: ¿adhesions were then noted throughout the midline.An additional port was placed in the left lower quadrant and lysis of adhesions was begun on the left side as mobilization was done of all omental adhesions.Omentum and small bowel were noted to be incarcerated in the hernia and these were reduced with sharp dissection in a circumferential fashion.Complete dissection time was 60 minutes for all lysis of adhesions to remove all contents including omentum and small bowel out of the hernia.Multiple hernias were also noted in the midline.These contents were examined and there was no evidence of any bowel injury noted or any problems noted after the lysis of adhesions.¿ the 10/4/2006 records continue: ¿at this point, the defect was measured and was noted to measure 30 cm x 20 cm gore-tex dual-mesh was then brought into the field.It was transfixed in four corners and then was brought in through the trocar site into the abdomen.It was transfixed onto the abdominal wall in four quadrants to accomplish attachments of the gore to the fascia.It was then circumferentially attached using a protac device to affix the mesh to the abdominal wall.Examination was next done throughout with there being no evidence of any complications or problems.Additionally, there were no organ injuries or evidence of bleeding noted after this part.Transfixion sutures were then placed around the mesh in a 6 cm circumferential around the mesh to affix this gore-tex.Multiple stab holes were made in the skin, as the sutures were tied.After this was complete, the initial trocar entry site was closed using gore-tex in a figure-of-eight fashion to complete all hernia repairs.¿ product identification records for the alleged gore device implanted on (b)(6) 2006 were not provided.There was no mention of infection or removal of the gore device previously implanted on (b)(6) 2005.Records between 10/4/2006 and 5/13/2016 were not provided.Operative records dated (b)(6) 2016 indicate the patient underwent: ¿1.Robotic incisional hernia repair with mesh, extraperitoneal tapp repair with progrip mesh.2.Explantation of old mesh.3.Robotic bilateral indirect inguinal hernia with progrip tapp mesh.4.Lysis of adhesions.¿ the records state: ¿the patient is a gentleman who had ongoing symptomatic pain associated with a right inguinal hernia.He also has an asymptomatic left inguinal hernia.He was also having lower midline pain and had recurrent incarcerated hernia beneath a previous hernia repair.¿ findings from the (b)(6) 2016 procedure state: ¿1.Previous hernia repair with a gore-tex mesh with an incarcerated hernia on the inferior portion of the mesh containing small bowel and fat.2.Adhesions of small bowel and omentum to anterior abdominal wall.Lysis of adhesions took approximately 60 minutes.3.Bilateral indirect inguinal hernias.4.Lower midline defect approximately _15 cm_ in length.5.No complications noted at the termination of the procedure.¿ the (b)(6) 2016 procedure notes state: ¿robotic system from da vinci was then docked to the patient.At this point, there was noted to be several adhesions to the anterior abdominal wall, both small bowel and omentum.These adhesions were carefully lysed with a combination of electrocautery and sharp dissection.Lysis of adhesions took approximately 60 minutes.In the midline of the anterior abdominal wall, there was a large gore-tex mesh, which was secured circumferentially with metal tack.The superior portion of the mesh was intact.However, it appeared that the bottom portion of the mesh towards the patient's pelvis had broken free and there was a hernia containing small bowel and fat in the inferior portion.The mesh at this area was adhered to the bowel and was divided to have access to the hernia contents.Once the mesh was divided, we were able to reduce the contents of the hernia with a combination of sharp dissection and electrocautery.Once the contents were reduced, this piece of mesh was removed off the small bowel carefully with sharp dissection and then passed off the field as specimen.¿ it is unclear from the medical records what meshes were explanted during the procedure.The (b)(6) 2016 procedure notes state regarding the bilateral inguinal hernias: ¿attention was then turned to the bilateral groins as the patient had bilateral inguinal hernias.A large preperitoneal flap over an entire pelvis was raised over the bilateral groins, and dissection was carried down into myopectineal orifice bilaterally.Examination of the myopectineal orifice showed indirect defects in both areas.The cord structures were identified.The cord structures were skeletonized as were cord lipomas bilaterally.At this point, there was also noted in the midline to be a defect approximately _15 cm_ in greatest dimension with the rectus splaying.This was brought back into re-apposition with a #1 stratafix in a running fashion.The midline defect was brought back together in re-apposition.¿ the (b)(6) 2016 inguinal hernia repair notes continue: ¿at this point, a progrip mesh was placed in a plug fashion in the deep ring and secured bilaterally.In keyhole fashion, progrip mesh was replaced around the cord structures and placed in the myopectineal orifice covering all openings.An additional piece of mesh measuring 7 cm x 15 cm was brought over the midline defect in a preperitoneal tapp location.It was placed and secured without difficulty.At this point, the gore-tex mesh above the mesh that was still intact was secured to the anterior abdominal wall with a running 0 prolene stitch.The peritoneum was then brought back up over the mesh repair in the pelvis and the bilateral groins up to the gore-tex mesh and secured with a 2-0 stratafix in a continuous fashion to extraperitonealize the mesh repair.Once this was completed, final examination was done of the abdomen.There was good hemostasis noted.¿ there was no mention of infection in the records.Pathology report dated 5/18/2016 regarding a specimen collected (b)(6) 2016 states: ¿soft tissue, hernia repair: synthetic material consistent with mesh (gross diagnosis only).Adherent fibromembranous tissue with giant cell reaction to foreign material.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Codes 4118/3221 - updated method/result codes.Product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.Conclusion code remains unchanged.Added medical record information.Surgical medical records dated on (b)(6) 2016 state: the patient ¿comes in today for ongoing followup after recent repair of incisional hernia and bilateral inguinal hernias.It seems mr.(b)(6) has been doing overall well since his discharge from the hospital.He had an uneventful stay here at (b)(6) center.He has been tolerating his diet.He has had no gi disturbances.He has been able to wean himself off his pain medication.He has been returned back to light activity with no major difficulties noted.¿ the records dated on (b)(6) 2016 continue: ¿abdomen: soft.There is well-healed trocar site from surgery.¿ surgical medical records dated on (b)(6) 2017 state: the patient ¿comes in today with ongoing pain mainly in the right abdomen, which is become more difficult with activities.He is noted no obstructive symptomatology is noted no evidence or any urologic problems with this.He is recent had recent cat scan which docs show no evidence of recurrent herniation at this site of his complaints on the right side docs show intact mesh repair or both in the midline as well as the groins.He is had no evidence or any obstructive symptomatology no evidence of any your gi complaints, no evidence of any urologic complaints.His major issues pain associated with this.¿ the records dated on (b)(6) 2017 continue: ¿abdomen soft.There is some musko skeletal spasm with a right mid abdomen.There is no joint discrete hernias or masses.¿ the records also state: ¿abdominal pain most likely due to scope musko skeletal deconditioning related to his repair.I did have a detailed discussion with him about options for treatment of this ongoing condition.¿ the records dated on (b)(6) 2017 state: ¿we discussed the options of physical therapy, and redilatation which mode would be most likely the most meaningful approach to this [sic].At this time, we discussed the use of warm heat, nonsteroidals to help with the pain management as well as abdominal wall reconditioning.¿ the records dated on (b)(6) 2017 continue: ¿i did discuss with him the option of removal of this mesh and movement to a larger procedures such as component separation which would reinforce his entire bowel wall [sic] musculature.Should he not be able to obtain adequate musko skeletal training to his abdominal wall.This is obviously much more involved procedure with potential increased risks and problems associated with removal is mesh and placement of a new mesh and repair of his abdominal wall with reconstruction.¿ surgical medical records dated on (b)(6) 2017 indicates patient seen ¿in the office today for follow-up after previous incisional hernia surgery.Prying [sic] comes in today with abdominal complaints, which a been [sic] more noticed left upper quadrant especially with physical activity.He does not note any increasing size mass, bulge or any changed along these lines.He does note evidence of any gi or urologic problems with this.He does say that the pain does become more difficult after more strenuous activities.¿ the records dated on (b)(6) 2017 state: ¿abdomen soft.There is well-healed trocar sites were surgery there is knowledge recurrent hernias musko skeletal spasm directly and left upper quadrant with palpable muscle bodies summation of pharyngeal seem norvasc intact.¿ records dated on (b)(6) 2017 continue: ¿i did discuss with him the pathophysiology of muscle spasm related to his previous hernia repair.I did discuss with the use of physical therapy, warm heat relaxation stretching, which may help this for him.I outlined with him physical limitations.He is he may need to have to help limit some of these muscle spasms and issues.Discuss use of nonsteroidal medication, which may help this as well.Asked him to follow up with you regarding these issues.Seems nonsurgical nature and should improve the musko skeletal training or decreasing activity and function.I did discuss with symptoms be concerning about recurrent hernias.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

B7: added medical history.H6: codes 4118/3221 - product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records dated (b)(6) 2006 state the patient was seen for consultation about recurrent ventral herniation.¿as you may recall, [the patient] had previous ventral hernia repairs performed for ongoing recurrent hernias.He initially had these issues start with appendicitis which was explored through a midline incision.Subsequent to this, he has had a recurrent herniation through the site.He has had attempted repairs done by both open and mesh repair approaches.He has been having recurrent pain and tenderness at the site.He most recently had a laparoscopic attempt for repair done in november of the past year.Since that time, he has had noted [sic] some fullness and tenderness in the right mid abdomen which is becoming increasingly more prominent for him.He has had bowel changes which has been intermittent in nature.He has been limited on his full activity because of this and wears a binder to help his abdominal wall.His past medical history is significant for gastroesophageal reflux disease.Past surgical history is significant for appendectomy, multiple ventral hernia repairs.¿ the (b)(6) 2006 records state: ¿abdomen: soft.There are previous trocar sites from his hernia.There is a mass in the mid abdomen, which seems reducible and has tenderness associated with it.He has had a previous lower midline, which seems more firm and no evidence of herniation at this point.¿ ¿it seems that [the patient] has questionable recurrence of his hernia in the right upper quadrant.He does have physical findings, which seem consistent with as was his symptomatology.At this point, [the patient] would like to proceed ahead with ventral hernia repair.It seems quite reasonable given his ongoing difficulties and bowel problems that he is having.Records dated (b)(6) 2006 indicate a gore® dualmesh® plus biomaterial with holes (1dlmcph07/04107053) was implanted during the procedure.There was no mention of infection or removal of the gore devices previously implanted on (b)(6) 2005.Records dated between 9/25/2014 and 4/12/2016 were not provided.Emergency room notes dated (b)(6) 2016 state: ¿this 53-year-old male presents [to the] emergency department with the chief complaint of abdominal pain.Patient has a history of multiple surgeries and multiple mesh repairs.Patient complains of pain primarily umbilical and right lower abdominal area.Patient status post cholecystectomy and appendectomy in the past.Patient presented here late 2014 with similar complaints.He had cat scan and other tests at that time which showed no evidence for significant pathology.Patient describes pain as moderate to severe and constant in nature for last several days.He denies vomiting or diarrhea.Denies fever or chills.Denies any aggravating or alleviating factors.¿ exam notes from the visit states: ¿abdomen: soft with normal bowel sounds.No rebound guarding or masses.Patient is tender across the anterior abdomen.¿ records regarding the ¿late 2014¿ visit were not provided.Imaging results dated (b)(6) 2016 state a ct of the abdomen and pelvis was performed.¿comparison: ct of the abdomen and pelvis performed (b)(6) 2014.¿ ¿there is no prior ventral hernia repair surgical mesh.There is no evidence of recurrence.A small, fat-containing right inguinal hernia is unchanged.Impression: no acute abdominal or pelvic process.¿ records for the (b)(6) 2014 ct scan were not provided.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

A4: added patient weight b7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2009: radiology.Ct pelvis/abdomen with contrast.Indication: abdominal pain; r/o emergent pathology.History: surgery.Left lower quadrant pain and tenderness.Findings: the lung bases are clear.The liver and spleen are normal in attenuation without hyper hypodense lesions.The intrahepatic biliary tree is nondilated.There are lamellated gallstones within the gallbladder.There is no gallbladder wall thickening.Within the kidneys there is no hydronephrosis, solid parenchymal masses or perinephric collections.There is a tiny 2 mm calcification in the mid calyx of the right kidney.There is mesh within the anterior abdominal wall likely from prior hernia repair.There is no mesenteric or retroperitoneal adenopathy.Within the true pelvis, there are no pathologic masses or collections.There is no pelvic adenopathy of ascites.Impression: 1.Tiny non-obstructing calculus in the calyx of the right kidney.2.Cholelithiasis.There is no diverticulitis.3.Several prominent lymph nodes in the right lower quadrant which can be seen with adenitis, although is probably of no clinical significance.(b)(6) 2009: radiology.Kub.Indication: right flank pain.Findings: several phleboliths in the right side of the true pelvis.There is also a 4 mm in maximal dimensions more linear appearing calcification closer to midline on the right side of the true pelvis thought to represent a distal ureteral calculi noted on ct urogram.Normal organ outlines where seen.Ventral hernia repair with mesh.Nondilated intestinal gas pattern.(b)(6) 2009: radiology.Ct abdomen and pelvis.Indication: right flank pain.Findings: lung bases are clear.Liver, spleen and pancreas are unremarkable.Several large calcified stones are identified in a nondistended gallbladder.No dilation of bile ducts.The adrenal glands are not enlarged.Mild nonspecific perinephric stranding on the right side.Mild right sided hydronephrosis and hydroureter all the way to the level of the vesicoureteral junction where there is a 4mm obstructing calculus.Normal appearing left kidney and collecting system.Previous ventral hernia repair with mesh.No bowel or mesenteric abnormalities, lymphadenopathy or ascites is seen.Impression: 1.There are two large calcified stones identified in nondistended and otherwise normal appearing gallbladder.2.4mm obstructing calculus distal right ureter with mild hydronephrosis and hydroureter and mild perinephric stranding on the right side.3.Previous ventral hernia repair.4.Small right inguinal hernia containing fat.(b)(6) 2011: office visit.F/u diabetes.Hpi: pt lost to f/u.Very frustrated due to continual abdominal pain at borders of mesh from hernia repair.When he mentioned to surgeon he was told they could take the mesh out which he didn¿t feel was a viable option.A.M.Sugars have been elevated.His main concern is his abdominal pain; it makes him miserable and has an effect on his family.Wt.219 lbs, bmi 33.3.Exam: abdomen: ttp at lateral edges of mesh.Orders: surgery referral ¿ dr.(b)(6) eval for ruq pain and for right flank pain.Question adhesions from mess [sic] vs.Mess [sic] failure.Labs: hgb a1c 8.6 high.Assessment/plan: diabetes, not stated as controlled: metformin rx¿d.Abdominal pain: adhesions from mesh and hernia repair; rx for ultram.(b)(6) 2013: radiology.Procedure: ct abd/pelvis w/ iv contrast.Indication: abdominal pain.Findings: lung bases: unremarkable.Liver: fatty.Spleen: unremarkable.Gallbladder: status post cholecystectomy.Pancreas: unremarkable.Adrenal glands: unremarkable.Kidneys: unremarkable.Cyst in the upper pole of the right kidney medially.Tiny calcification in the lower pole of left kidney.Stomach and bowel: unremarkable.Appendix: not visualized.Bladder: unremarkable.Prostate calcifications.Other: no lymphadenopathy.No free fluid.Anterior surgical mesh.Right inguinal hernia containing fat.Bones: no osteolytic or osteoblastic mass.Impression: no acute abnormality identified.Ct abdomen/pelvis dated (b)(6)2013 for history of abdominal pain states: ¿impression: no acute abnormality identified.¿ (b)(6) 2014: radiology.Ct abdomen/pelvis.Indication: abdomen/flank pain, question kidney stone.Findings: lung bases-grossly clear.Liver/spleen-homogeneous.Gallbladder-surgically absent.Pancreas-grossly normal.Adrenals/kidneys-moderately severe right hydroureteronephrosis.Ureter is dilated down to the right upj.3.7mm stone at the right uvj.No left sided hydronephrosis.Scattered punctate calcifications at the papillary level of the left kidney.Analysis of the renal parenchyma is limited by lack of contrast.17 mm cyst in the upper pole of the right kidney is stable since the previous, which was performed with iv contrast.No other gross renal parenchymal abnormality noted.Retroperitoneum- no lymphadenopathy.Bowels-no edema or dilation.Pelvis-urinary bladder normal.Bones-no gross lesions.Misc.-status post ventral hernia repair with at least 3 segments of anterior abdominal wall mesh.Moderate right inguinal hernia is noted containing fatty tissue.Impression: right uvj calculus 3.7 mm with right moderately severe hydroureteronephrosis.(b)(6) 2014: radiology.Procedure: ct abd/pelvis.Indication: right flank pain.Comparison (b)(6) 2014.Findings: resolution of previously seen right hydronephrosis and hydroureter.Right uvj calculus no longer detected.No right-sided nephrolithiasis.Punctate left mid pole nephroliths, without obstruction.No left ureter calculi.No urinary bladder stones detected.Visualized lung bases clear.Previous cholecystectomy.Previous abdominal wall hernia repair, with stable appearance of mesh.The liver is diffusely decreased in attenuation suggesting fatty infiltration.The non-iv contrasted spleen, pancreas, and adrenal glands appear grossly within normal limits.No obstructing bowel masses detected.No pathologically enlarged lymph nodes.No free air or free fluid.Right inguinal canal hernia containing mesenteric fat.Impression: resolution of right hydronephrosis and hydroureter, consistent with passage of stone.Non-obstructing punctate left nephrolith.(b)(6) 2014: office notes.Follow up type ii diabetes mellitus without complication.Started r side travels to l side gas pain cannot get rid of it.Sweating all the time but has no temp.Continues to have abd pain and bloating and gas last pm was in a lot of pain.Diarrhea continues has noted no blood or black vomiting.Reports saw surgeon and he did mention pain management, and then discussed surgeons in albany that may be able to operate and go thru mesh to do exploratory surgery but this is very risky.Pt feels frustrated.No barriers to self-care exist.Abdominal pain location: rlq; radiating to left abd.Quality: pain; bloating; aching; tender.Severity: moderate.Duration: constant.Gradual onset/timing.Nothing gives relief.Associated symptoms: heartburn (uses omeprazole); diarrhea.Wt.: 212 lbs.Bmi: 32.3.Pain scale: 9.Exam: unremarkable except obese.Impression: type ii diabetes mellitus without complication.Abdominal pain, unspecified site-i wonder about ibs and we did discuss sxs [sic] treatment, will have gi evaluate and will try levsin for gas and bloating.Continue hydrocodone prn.Discussed adhesions and he has had multiple abd surgeries and this is a real possibility.Gastroenterology referral-schedule within: provider¿s discretion.Note to provider: 51 y/o male with persistent abd pain and gas and diarrhea, 2 mos.Workup is negative thus far please evaluate for ibs.Diarrhea.(b)(6) 2014: emergency room visit.Abdominal pain.Past surgical history of abdominal hernia repairs with 2 subsequent mesh placements.States he has had mild pain intermittently since his original hernia surgeries over the past 3 months.He states that apparently he had a ct scan for evaluation of a kidney stone complaints somewhere between 6 months to one year ago and apparently there was concern about some new hernia ¿underneath the mesh¿.He states that he has seen his surgeon but they are pending waiting for review of the images of the ct scan.Diagnoses: abdominal pain, right renal nonobstructing kidney stone, mild acute renal insufficiency, mild dehydration.Plan: discharged home.(b)(6)14: radiology.Procedure: ct abd/pelvis w/iv contrast.Indication: nonspecific abdominal pain; r/o emergent pathology.Findings: lung bases: unremarkable.Liver: fatty.Spleen: unremarkable.Gallbladder: status post cholecystectomy.Pancreas: unremarkable.Adrenal glands: unremarkable.Kidneys: 19.6 mm simple appearing cyst in the upper right kidney medially.2.3 mm calculus in the mid left kidney.No hydronephrosis or solid renal masses.Stomach and bowel: no obstruction.Two anterior surgical mesh placements.Appendix: not visualized.Bladder: unremarkable.Prostate calcification.Other: no lymphadenopathy.No free fluid.Bones: no osteolytic or osteoblastic mass.Impression: no acute abnormality seen.(b)(6) 2014: office notes.Cc: chronic diarrhea up to several times daily for 2-3 months; lost about 30 pounds; o&p x 3 and a stool culture was done; does have intermittent abdominal cramping and nausea but no vomiting; had a ct scan, bloodwork; had pain in right side of abdomen for 10 years which has been dx as muscle strain but it has gotten worse in the past few months; went to er last wednesday for severe abdominal pain-ct scan was done which showed a kidney stone; colonoscopy was ordered but since a screening was done last year a diagnostic will cost $175.00.Hpi: unremarkable except has been having a very well localized pain in the right side of his abdominal wall.It feels like a needle poking him for several years, since having mesh implanted in his abdominal wall for a large ventral hernia.Sometimes feels hot and flushed during these episodes.Pain is colicky and migratory but seems to be for the most part in the right side of his abdomen.He doesn¿t vomit but does have early satiety and has been eating less so has lost 30 pounds during this process.He drinks a glass of milk with dinner every night but other than that does not consume a lot of dairy products.He has not been on any antibiotics or probiotics recently.This led to the ventral hernias which were repaired twice and this has led in the patient¿s mind anyway to the pain on the right side of his abdomen which he feels is from the match [sic].Surgeon allegedly told him that he was in reality a ¿pulled muscle¿.Patient admits that even the pain on the right side of his mesh which was so sharp before has lessened significantly although he can still feel it.Recent upper gi series and small bowl follow-through was normal except for a small hiatal hernia.He has been on metformin for many years without any other side effects.Wt.: 201 lbs.Bmi: 30.6.Exam: tenderness and a small area of his right midabdomen that he can literally put his finger on.There is no obvious mass in the area that may represent the lateral margins of the mesh.Impression: symptoms are nonspecific and could well represent an irritable bowel syndrome, but with previous bowel surgeries and weight loss we certainly have to consider other possibilities including inflammatory bowel disease such as crohn¿s disease, intestinal malignancy, adhesions with kinking of the small or large intestine et cetera.Advised patient to start himself on a probiotic supplements such as align twice daily and a fiber supplement twice daily as well.Advised him to stop drinking milk.We will get an upper gi and small bowel series on him and will recheck him in a few weeks.She [sic] will register in the patient portal to keep me informed of any change in his symptoms between visits.May try to prescribe him a lidoderm patch for the trigger point area on his abdominal wall next time if necessary and will consider putting him on amitriptyline if this seems to be more of an ibs-type problem.If all else fails then we may need to proceed with colonoscopy with doctor herlihy despite the high co-pay.Dx: abdominal pain-right side of abdomen-upper gastrointestinal w/ small bowel.Type ii diabetes mellitus without complication.Diarrhea.(b)(6) 2014: radiology.Procedure: upper gi w/ small bowel.Indication: lower abdominal pain, 30 lbs.Weight loss over 4 weeks, several abdominal surgeries including mesh placement.Kub: normal bowel gas pattern.Numerous surgical clips present including cholecystectomy clips right upper quadrant.Esophagus: no constricting or obstructing masses noted.Small hiatus hernia is present.Stomach: normal anatomic position with normal mucosal contours.Duodenum: grossly normal peristaltic activity.Small diverticulum in the second portion of the duodenum.No acute inflammation, constricting or obstructing masses.Small intestines: grossly normal mucosal patterns and parastasis.Terminal ileum: barium reaches colon at 30 minutes.Normal ti mucosal contours and activity.Impression: 1.Small hiatus hernia without active ge reflux.2.Incidental note of small duodenal diverticulum.3.No acute intestinal pathology identified.(b)(6) 2014: hudson headwaters health network, indian lake health center.Daniel way, md.Office notes.Has had his appendix and gallbladder removed.This led to the ventral hernias which were repaired twice and this has led in the patient¿s mind anyway to the pain on the right side of his abdomen which he feels is from the match [sic].Surgeon allegedly told him that he was in reality a ¿pulled muscle¿.Patient admits that even the pain on the right side of his mesh which was so sharp before has lessened significantly although he can still feel it.He has been on metformin for many years without any other side effects.Wt.: 200 lbs.Bmi: 30.5.Impression/plan: 1.Abdominal pain-right side of abdomen.2.Irritable bowel syndrome.Amitriptyline rx¿d.2.Type ii diabetes mellitus without complication- hemoglobin a1c, cmp, lipid panel.Goal a1c: less than 7.0.(b)(6)17: radiology.Procedure: ct abd/pelvis w/ iv contrast.Indication: inguinal pain.History: inguinal pain.Comparison: (b)(6) 2006.Findings: lower thorax: no consolidation or effusion.Stomach: grossly within normal limits.Liver: no worrisome masses.No ductal dilation.Decreased in attenuation consistent with steatosis.Gallbladder: cholecystectomy.Adrenals: normal.Pancreas: normal for age.Spleen: normal.Kidneys: no solid parenchymal renal mass.Punctate calculus lower calyx left kidney.1.9 cm cyst right kidney, which is stable.No hydronephrosis.Vascular: mild atherosclerosis.Bowel: no inflammatory changes within the bowel.Peritoneum/retroperitoneum: no lymphadenopathy.No ascites.Reproductive: normal for age.Bladder: grossly unremarkable.Bones: nothing acute.Abdominal wall: mesh within the anterior abdominal wall which is stable.There is an associated midline anterior abdominal wall laxity.There is a right indirect inguinal hernia containing fat, but no bowel.Impression: 1.Small right direct inguinal fat but no bowel, which is stable.2.Punctate calculus lower calyx left kidney.3.Steatosis.4.Benign cyst right kidney.(b)(6) 2018: office notes.Type 2 diabetes mellitus without complication.Hpi: cad/hypertension self-care: gets regular exercise: 3 or more times per week; does not check blood pressure at home; weigh not at goal; goal is (200); does not follow low sodium diet.Diabetes self-care: seeing eye doctor yearly for dilated eye exam; checking feet regularly; not monitoring home glucose.Taking meds as directed.Stopped statin due to cramping.Cardiology instructed him to take ½ pill once a week.Explain anti-inflammatory effects and antioxidant effect of statin and the importance in a diabetic to be on one.Abdominal mesh still bothersome.Has been told he will just have to live with it.Ok with rare hydrocodone use when real bothersome.Helps alleviate discomfort/pain.Was out of glimepiride for over a month, pharmacy never sent it to him.Noted he was unbearably thirsty when off of it.Recently back on and that has resolved.No reported low bs¿s.A1c reflective of that.Wt.: 208 lbs.Bmi: 31.6.Exam: unremarkable except overly nourished.Bmi=31.6.Hemoglobin a1c-(b)(6) 2018: 9.5 high.Glucose-(b)(6) 2018: 226 high.Impression/plan: type 2 diabetes mellitus without complication-poorly controlled.A1c=9.5.Off glimepiride for a month.Increase to 2 mg daily.Monitor bs at home.(b)(6) 2018: office notes.Type 2 diabetes mellitus without complication.Gets regular exercise: 3 or more times per week; doesn¿t check blood pressure at home; weight not at goal; does not follow low sodium diet.Developed sxs [sic] pf pain on sat nite [sic] then today noted rash on back.Works as corrections officer.Wt.: 207 lbs.Bmi: 31.5.Impression/plan: 1.Type 2 diabetes mellitus without complication.2.Herpes zoster-care and precautions reviewed.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2009: (b)(6) hospital.(b)(6) , rn.Nurse notes.Left lower abdomen pain x 3 days; sent from health center.Wt.100 kg.Abdomen: rounded, tender.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the instructions for gore® dualmesh® biomaterial use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

H6: updated patient codes [none].H6: updated device codes [none].H6: updated conclusion codes.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Previous patient codes (1695, 2240, 1994) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Medical records investigation summary.The following information was determined from the medical records.Medical records: ¿known medical records span july 11, 2005 through july 23, 2018 and not all records received in this time span are relevant to the alleged gore® dualmesh® plus biomaterial, gore® dualmesh® biomaterial, and the gore® dualmesh® plus biomaterial with holes.¿medical records from october 4, 2006 through january 10, 2009; september 10, 2009 through february 9, 2011; february 9, 2011 through january 17, 2013, and november 18, 2014 through april 12, 2016 were not provided.Patient information medical history: ¿type ii diabetes 2006: diagnosed.(b)(6) 2011: hgb a1c 8.6 [high].Metformin.Uncontrolled diabetes.Lost to follow-up.(b)(6) 2018: hgb a1c 9.5 [high].Poorly controlled, glucose 226 [high].Glimepiride.(b)(6) 2018: ¿not monitoring home glucose, was out of glimepiride for over one month.¿.¿gastroesophageal reflux disease [gerd].¿hypertension.(b)(6) 2018: ¿does not check blood pressure at home, does not follow low sodium diet.¿ ¿hyperlipidemia.(b)(6) 2018: ¿stopped statin due to cramping.¿.¿coronary artery disease.¿irritable bowel syndrome.¿obesity.(b)(6) 2009: 241 lbs., bmi 36.6.(b)(6) 2011: 219 lbs., bmi 33.3.(b)(6) 2014: 212 lbs., bmi: 32.3.(b)(6) 2014: 201 lbs., bmi 30.6.(b)(6) 2018: 208 lbs., bmi 31.6.(b)(6) 2018: 207 lbs., bmi 31.5, ¿weight not at goal.¿.Prior surgical procedures: ¿(b)(6) : exploratory laparotomy; probable appendectomy.¿unknown date: cholecystectomy.Implant #1 preoperative complaints: none received.Implant #1 procedure: open ventral hernia repair with mesh.Product identification records for the alleged gore device were not provided [¿impregnated dualmesh¿ 10cm x 14 cm].Implant #1 date: (b)(6) 2005 [hospitalization dates unknown].¿description of hernia being treated: ¿the previously placed scar was excised, and the hernia sac entered.Adhesions of omentum and the hernia sac were taken down, and the omentum placed back into the abdominal cavity.Only minor adhesions were identified thereafter, but there were a few cicatrices around the small bowel which were divided.The small bowel was run and all adhesions were divided.¿.¿implant size and fixation: ¿using interrupted #2 nylon and #1 prolene, the gap at both the upper and the lower end was partially closed and a 10x14 cm portion of impregnated dualmesh inserted and secured with interrupted #2 nylon sutures placed in such a fashion that the mesh overlapped the posterior edge of the anterior abdominal wall by at least 3 cm in all areas.In this fashion, the hernia was closed.The tissue immediately superior to the mesh was closed over it with a running 0 vicryl suture.¿.Relevant medical information: no medical records provided.Implant #2 preoperative complaints: ¿(b)(6) 2005: ¿.Who had undergone an exploratory laparotomy in (b)(6) 2005.After the procedure, he developed a ventral hernia which was repaired using an open technique in (b)(6).The patient presented to the office complaining of persistent pain along the right lower abdomen, just adjacent to the mesh, extending down into the lower pelvis.Ct scan showed a small fascial defect, but no obvious recurrence of the hernia.¿.Implant #2 procedure: laparoscopic ventral hernia repair with mesh.Product identification records for the alleged gore device were not provided [¿gore dual mesh¿ 8 cm x 10 cm].Implant #2 date: (b)(6) 2005 [hospitalization dates unknown].¿description of hernia being treated: ¿a small recurrent hernia was identified at the superior aspect of the incision over the previous mesh.In the area of the patient¿s most significant tenderness, in the right lower quadrant, there was no evidence of recurrent hernia or other obvious pathology to explain the patient¿s symptoms.¿ ¿blunt dissection was then used to take down several adhesions of omentum to the undersurface of the previous mesh.¿ ¿this same procedure was performed on the left lower quadrant after freeing up several adhesions.Several loops of small bowel were noted to be loosely adherent to the mesh and were taken down using blunt dissection.When all adhesions had been completely removed, the mesh was examined and a small recurrent defect approximately 6 x 6 cm in diameter was noted at the superior aspect of the mesh.¿.¿implant size and fixation: ¿this was marked on the surface of the skin and a gore dual mesh was cut into oval fashion using an 8 x 10 cm mesh.Anchoring sutures were placed in four quadrants of o gore-tex.This was then rolled into a cigar shape.¿ ¿using the gore needle-passer, the four stay sutures were brought up in four quadrants through small abdominal wall incisions.There were then tied to anchor the mesh.Four other sutures were passed through the abdominal wall through small incisions using a gore needle-passer to further anchor the mesh.The free edges of the mesh were clipped using the wire tacker.At this point, a small bulge was noted just to the right portion of the mesh, just above the umbilicus.This was not a definite fascial defect, but slight laxity was definitely noted.The mesh in this area was approximated to the healthy fascia using interrupted sutures of 0 gore-tex.This was performed using the gore needle-passer.At this point, hemostasis was noted to be complete.¿.Relevant medical information: no medical records provided.Implant #3 preoperative complaints: ¿(b)(6) 2006: ¿as you may recall, [the patient] ¿ had previous ventral hernia repairs performed for ongoing recurrent hernias.He initially had these issues start with appendicitis which was explored through a midline incision.Subsequent to this, he has had a recurrent herniation through the site.He has had attempted repairs done by both open and mesh repair approaches.He has been having recurrent pain and tenderness at the site.He most recently had a laparoscopic attempt for repair done in november of the past year.Since that time, he has had noted [sic] some fullness and tenderness in the right mid abdomen which is becoming increasingly more prominent for him.He has had bowel changes which has been intermittent in nature.He has been limited on his full activity because of this and wears a binder to help his abdominal wall.¿ "there is a mass in the mid abdomen, which seems reducible and has tenderness associated with it.He has had a previous lower midline, which seems more firm and no evidence of herniation at this point.¿ ¿it seems that [the patient] has questionable recurrence of his hernia in the right upper quadrant.He does have physical findings, which seem consistent with as was his symptomatology.¿ ¿at this point, [the patient] would like to proceed ahead with ventral hernia repair.It seems quite reasonable given his ongoing difficulties and bowel problems that he is having.¿.Implant #3 procedure: laparoscopic ventral hernia repair with mesh.Implant: gore® dualmesh® plus biomaterial with holes (1dlmcph07/04107053, 30cm x 20cm) implant #3 date: (b)(6) 2006 [unknown hospitalization dates].¿description of hernia being treated: ¿adhesions were then noted throughout the midline.An additional port was placed in the left lower quadrant and lysis of adhesions was begun on the left side as mobilization was done of all omental adhesions.Omentum and small bowel were noted to be incarcerated in the hernia and these were reduced with sharp dissection in a circumferential fashion.Complete dissection time was 60 minutes for all lysis of adhesions to remove all contents including omentum and small bowel out of the hernia.Multiple hernias were also noted in the midline.These contents were examined and there was no evidence of any bowel injury noted or any problems noted after the lysis of adhesions.¿ ¿implant size and fixation: ¿at this point, the defect was measured and was noted to measure 30 cm x 20 cm gore-tex dual-mesh was then brought into the field.It was transfixed in four corners and then was brought in through the trocar site into the abdomen.It was transfixed onto the abdominal wall in four quadrants to accomplish attachments of the gore to the fascia.It was then circumferentially attached using a protac device to affix the mesh to the abdominal wall.Examination was next done throughout with there being no evidence of any complications or problems.¿ ¿transfixion sutures were then placed around the mesh in a 6 cm circumferential around the mesh to affix this gore-tex.Multiple stab holes were made in the skin, as the sutures were tied.After this was complete, the initial trocar entry site was closed using gore-tex in a figure-of-eight fashion to complete all hernia repairs.¿ relevant medical information: ¿(b)(6) 2009: ct abdomen: ¿there is mesh within the anterior abdominal wall likely from prior hernia repair.¿.(b)(6) 2009: ct abdomen: ¿previous ventral hernia repair.Small right inguinal hernia containing fat.¿.¿(b)(6) 2011: lost to follow-up.¿very frustrated due to continual abdominal pain at borders of mesh from hernia repair.When he mentioned to surgeon he was told they could take the mesh out which he didn¿t feel was a viable option.¿ ¿exam: abdomen: ttp [tender to palpation] at lateral edges of mesh.¿ surgical referral.¿question adhesions from mess [sic, mesh] vs.Mess [sic, mesh] failure.¿.¿(b)(6) 2013: ¿.Here for evaluation of left sided lower abdominal pain which started about 3 mos ago when mesh was surgically implanted to repair problems from hernia operations done in the past.The pain has been present intermittently since surgery but would only last up to 15 minutes; pain started today at noon and has been present ever since;.¿ ¿had hernia repair by dr.Anderson and then subsequent rerepair with mesh by dr.Singh in albany.When pt was having problems and went back to see dr.Singh he was told in a very blunt manner ¿well we will just remove it then.¿ pt chose not to follow up with him and has just put up with the discomfort.¿ ¿ruq [right upper quadrant] tenderness and rlq [right lower quadrant] tenderness.¿ ¿no hernia palpable.¿ ¿(b)(6) 2013: ct abdomen: ¿anterior surgical mesh.Right inguinal hernia containing fat.¿ ¿(b)(6) 2014: ct abdomen: ¿misc.-status post ventral hernia repair with at least 3 segments of anterior abdominal wall mesh.Moderate right inguinal hernia is noted containing fatty tissue.¿ ¿.Right moderately severe hydroureteronephrosis.¿.¿(b)(6) 2014: ct abdomen: ¿resolution of right hydronephrosis and hydroureter.Right inguinal canal hernia containing mesenteric fat.¿.¿(b)(6) 2014: continues to have abdominal pain.¿reports saw surgeon and he did mention pain management, and then discussed surgeons in albany that may be able to operate and go thru mesh to do exploratory surgery but this is very risky.Pt feels frustrated.¿ gastrointestinal [gi] consult for persistent abdominal pain, gas and diarrhea, with negative workup for two months.Evaluate for irritable bowel syndrome.¿(b)(6) 2014: evaluated for previously repaired hernia.Some pain and tenderness associated with activity.¿there is no evidence of recurrent hernia on palpation or on valsalva.There is no evidence of any other masses.¿.¿(b)(6) 2014: ct abdomen: ¿two anterior surgical mesh placements.No acute abnormality seen.¿.¿(b)(6) 2014: chronic diarrhea up to several times daily for 2-3 months.Lost about 30 lbs.¿hpi: unremarkable except has been having a very well localized pain in the right side of his abdominal wall.It feels like a needle poking him for several years, since having mesh implanted in his abdominal wall for a large ventral hernia.¿ ¿patient admits that even the pain on the right side of his mesh which was so sharp before has lessened significantly although he can still feel it.¿ ¿exam: tenderness and a small area of his right midabdomen that he can literally put his finger on.There is no obvious mass in the area that may represent the lateral margins of the mesh.¿.¿(b)(6) 2016: ct abdomen: ¿there is no prior ventral hernia repair surgical mesh.There is no evidence of recurrence.A small, fat-containing right inguinal hernia is unchanged.¿ explant preoperative complaints: ¿(b)(6) 2016:.¿comes in today for evaluation of ongoing problems with bilateral inguinal hernias.It seems that the patient is someone we had seen in the past regarding repair.He has had increasing pain, tenderness, and problems associated with his hernias and had a recent er visit for this.He has had findings on scan consistent with a hernia and was sent for reevaluation.He has had bowel and bladder changes associated with this and has increasing pain, which has been his primary drivers.¿ ¿abdomen: soft.There is a small midline defect which is reducible.There is evidence of recurrence of mass within the right groin.There is no other tenderness.It seems that the patient has both by ct scan and by exam recurrent hernias, which at this point cause more problems.We did discuss with him options for treatment for this.We did discuss with him ongoing changes he may see after surgical intervention.¿.Explant procedure: ¿1.Robotic incisional hernia repair with mesh, extraperitoneal tapp [transabdominal preperitoneal] repair with progrip mesh.2.Explantation of old mesh.3.Robotic bilateral indirect inguinal hernia with progrip tapp mesh.4.Lysis of adhesions.¿ explant date: (b)(6) 2016 [hospitalization dates unknown].¿¿1.Previous hernia repair with a gore-tex mesh with an incarcerated hernia on the inferior portion of the mesh containing small bowel and fat.2.Adhesions of small bowel and omentum to anterior abdominal wall.Lysis of adhesions took approximately 60 minutes.3.Bilateral indirect inguinal hernias.4.Lower midline defect approximately 15 cm in length.5.No complications noted at the termination of the procedure.¿ ¿¿in the midline of the anterior abdominal wall, there was a large gore-tex mesh, which was secured circumferentially with metal tack.The superior portion of the mesh was intact.However, it appeared that the bottom portion of the mesh towards the patient's pelvis had broken free and there was a hernia containing small bowel and fat in the inferior portion.The mesh at this area was adhered to the bowel and was divided to have access to the hernia contents.Once the mesh was divided, we were able to reduce the contents of the hernia with a combination of sharp dissection and electrocautery.Once the contents were reduced, this piece of mesh was removed off the small bowel carefully with sharp dissection and then passed off the field as specimen.¿ ¿¿at this point, the gore-tex mesh above the mesh that was still intact was secured to the anterior abdominal wall with a running 0 prolene stitch.The peritoneum was then brought back up over the mesh repair in the pelvis and the bilateral groins up to the gore-tex mesh and secured with a 2-0 stratafix in a continuous fashion to extraperitonealize the mesh repair.Once this was completed, final examination was done of the abdomen.There was good hemostasis noted.¿ (b)(6) 2016: pathology report: ¿specimen: gross examination, explanted mesh.¿ gross description: ¿the specimen received is labeled explanted mesh.The specimen is received in formalin and measures 8.5 x 4.0 x 0.3 cm.The mesh like fragments are attached to multiple coiled metallic rings.¿ ¿final diagnosis: soft tissue, hernia repair: synthetic material consistent with mesh (gross diagnosis only).Adherent fibromembranous tissue with giant cell reaction to foreign material.¿ relevant medical information: ¿(b)(6) 2016: ¿.Has been doing overall well since his discharge from the hospital.He has been able to wean himself off his pain medication.He has been returned back to light activity with no major difficulties noted.¿.¿(b)(6) 2017: ¿pt had a previous abdominal hernia which the mesh had failed in and had to have the whole huge piece replaced.Has had discomfort into the inguinal regions bilaterally and into other areas of the mesh.¿.¿(b)(6) 2017: ¿.Ongoing pain mainly in the right abdomen, which is become more difficult with activities.He is noted no obstructive symptomatology is noted no evidence or any urologic problems with this.Recent cat scan which does show no evidence of recurrent herniation at this site of his complaints on the right side does show intact mesh repair or both in the midline as well as the groins.¿ "i did discuss with him the option of removal of this mesh and movement to a larger procedures such as component separation which would reinforce his entire bowel wall sic] musculature.Should he not be able to obtain adequate musko skeletal [sic] training to his abdominal wall.This is obviously much more involved procedure with potential increased risks and problems associated with removal is mesh and placement of a new mesh and repair of his abdominal wall with reconstruction.¿.¿(b)(6) 2017: ct abdomen: ¿mesh within the anterior abdominal wall which is stable.There is an associated midline anterior abdominal wall laxity.There is a right indirect inguinal hernia containing fat, but no bowel.¿ ¿(b)(6) 2017: ¿.Here for evaluation of across entire mid abdominal wall which has been present for years but had gotten worse in the past month;¿ ¿pt continues to have abdominal pain in a squared off pattern consistent with his mesh from his hernia repair.He had a ct in feb which showed a fatty rih [right inguinal hernia] but no disruption of the mesh.¿ pain on the left side feels like a knife stabbing him when he is seated.The other option was to have to mesh removed.¿ unable to afford recommended physical therapy.¿(b)(6) 2018: ¿abdominal mesh still bothersome.Has been told he will just have to live with it.¿ it should be noted that the gore® dualmesh® plus biomaterial, instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® plus biomaterial instructions for use also states, ¿cutting gore® dualmesh® plus biomaterial, to the proper size is essential.Use sharp surgical instruments to trim the mesh.If gore® dualmesh® plus biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Based upon the information received, the device remains in the patient and was not available for evaluation.Review of the manufacturing records verified that the lots met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

H6: updated patient codes [none].H6: updated device codes [none].H6: updated conclusion codes.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Previous patient codes (1695, 2240, 1994) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Medical records investigation summary.The following information was determined from the medical records.Medical records: known medical records span (b)(6) 2005 through (b)(6) 2018 and not all records received in this time span are relevant to the alleged gore® dualmesh® plus biomaterial, gore® dualmesh® biomaterial, and the gore® dualmesh® plus biomaterial with holes.Medical records from (b)(6) 2006 through (b)(6) 2009; (b)(6) 2009 through (b)(6) 2011; (b)(6) 2011 through (b)(6) 2013, and (b)(6) , 2014 through (b)(6) , 2016 were not provided.Patient information.Medical history: type ii diabetes.2006: diagnosed.(b)(6) 2011: hgb a1c 8.6 [high].Metformin.Uncontrolled diabetes.Lost to follow-up.(b)(6) 2018: hgb a1c 9.5 [high].Poorly controlled, glucose 226 [high].Glimepiride.(b)(6) 2018: ¿not monitoring home glucose, was out of glimepiride for over one month.¿ gastroesophageal reflux disease [gerd].Hypertension.(b)(6) 2018: ¿does not check blood pressure at home, does not follow low sodium diet.¿ hyperlipidemia.(b)(6) 2018: ¿stopped statin due to cramping.¿ coronary artery disease.Irritable bowel syndrome.Obesity.(b)(6) 2009: 241 lbs.Bmi 36.6.(b)(6) 2011: 219 lbs.Bmi 33.3.(b)(6) 2014: 212 lbs.Bmi: 32.3.(b)(6) 2014: 201 lbs.Bmi 30.6.(b)(6) 2018: 208 lbs.Bmi 31.6.(b)(6) 2018: 207 lbs.Bmi 31.5, ¿weight not at goal.¿ prior surgical procedures: (b)(6) 2005: exploratory laparotomy; probable appendectomy.Unknown date: cholecystectomy.Implant #1 preoperative complaints: none received.Implant #1 procedure: open ventral hernia repair with mesh.Product identification records for the alleged gore device were not provided [¿impregnated dualmesh¿ 10cm x 14 cm].Implant #1 date: (b)(6) 2005 [hospitalization dates unknown].Description of hernia being treated: ¿the previously placed scar was excised, and the hernia sac entered.Adhesions of omentum and the hernia sac were taken down, and the omentum placed back into the abdominal cavity.Only minor adhesions were identified thereafter, but there were a few cicatrices around the small bowel which were divided.The small bowel was run and all adhesions were divided.¿ implant size and fixation: ¿using interrupted #2 nylon and #1 prolene, the gap at both the upper and the lower end was partially closed and a 10x14 cm portion of impregnated dualmesh inserted and secured with interrupted #2 nylon sutures placed in such a fashion that the mesh overlapped the posterior edge of the anterior abdominal wall by at least 3 cm in all areas.In this fashion, the hernia was closed.The tissue immediately superior to the mesh was closed over it with a running 0 vicryl suture.¿ relevant medical information: no medical records provided.Implant #2 preoperative complaints: (b)(6) 2005: ¿ who had undergone an exploratory laparotomy in (b)(6) 2005.After the procedure, he developed a ventral hernia which was repaired using an open technique in (b)(6).The patient presented to the office complaining of persistent pain along the right lower abdomen, just adjacent to the mesh, extending down into the lower pelvis.Ct scan showed a small fascial defect, but no obvious recurrence of the hernia.¿ implant #2 procedure: laparoscopic ventral hernia repair with mesh.Product identification records for the alleged gore device were not provided [¿gore dual mesh¿ 8 cm x 10 cm].Implant #2 date: (b)(6) 2005 [hospitalization dates unknown].Description of hernia being treated: ¿a small recurrent hernia was identified at the superior aspect of the incision over the previous mesh.In the area of the patient¿s most significant tenderness, in the right lower quadrant, there was no evidence of recurrent hernia or other obvious pathology to explain the patient¿s symptoms.¿ ¿blunt dissection was then used to take down several adhesions of omentum to the undersurface of the previous mesh.¿ ¿this same procedure was performed on the left lower quadrant after freeing up several adhesions.Several loops of small bowel were noted to be loosely adherent to the mesh and were taken down using blunt dissection.When all adhesions had been completely removed, the mesh was examined and a small recurrent defect approximately 6 x 6 cm in diameter was noted at the superior aspect of the mesh.¿ implant size and fixation: ¿this was marked on the surface of the skin and a gore dual mesh was cut into oval fashion using an 8 x 10 cm mesh.Anchoring sutures were placed in four quadrants of o gore-tex.This was then rolled into a cigar shape.¿ ¿using the gore needle-passer, the four stay sutures were brought up in four quadrants through small abdominal wall incisions.There were then tied to anchor the mesh.Four other sutures were passed through the abdominal wall through small incisions using a gore needle-passer to further anchor the mesh.The free edges of the mesh were clipped using the wire tacker.At this point, a small bulge was noted just to the right portion of the mesh, just above the umbilicus.This was not a definite fascial defect, but slight laxity was definitely noted.The mesh in this area was approximated to the healthy fascia using interrupted sutures of 0 gore-tex.This was performed using the gore needle-passer.At this point, hemostasis was noted to be complete.¿ relevant medical information: no medical records provided.Implant #3 preoperative complaints: (b)(6) 2006: ¿as you may recall, [the patient] had previous ventral hernia repairs performed for ongoing recurrent hernias.He initially had these issues start with appendicitis which was explored through a midline incision.Subsequent to this, he has had a recurrent herniation through the site.He has had attempted repairs done by both open and mesh repair approaches.He has been having recurrent pain and tenderness at the site.He most recently had a laparoscopic attempt for repair done in november of the past year.Since that time, he has had noted [sic] some fullness and tenderness in the right mid abdomen which is becoming increasingly more prominent for him.He has had bowel changes which has been intermittent in nature.He has been limited on his full activity because of this and wears a binder to help his abdominal wall.¿ "there is a mass in the mid abdomen, which seems reducible and has tenderness associated with it.He has had a previous lower midline, which seems more firm and no evidence of herniation at this point.¿ ¿it seems that [the patient] has questionable recurrence of his hernia in the right upper quadrant.He does have physical findings, which seem consistent with as was his symptomatology.¿ ¿at this point, [the patient] would like to proceed ahead with ventral hernia repair.It seems quite reasonable given his ongoing difficulties and bowel problems that he is having.¿ implant #3 procedure: laparoscopic ventral hernia repair with mesh.Implant: gore® dualmesh® plus biomaterial with holes (1dlmcph07/04107053, 30cm x 20cm) implant #3 date: (b)(6) 2006 [unknown hospitalization dates].Description of hernia being treated: ¿adhesions were then noted throughout the midline.An additional port was placed in the left lower quadrant and lysis of adhesions was begun on the left side as mobilization was done of all omental adhesions.Omentum and small bowel were noted to be incarcerated in the hernia and these were reduced with sharp dissection in a circumferential fashion.Complete dissection time was 60 minutes for all lysis of adhesions to remove all contents including omentum and small bowel out of the hernia.Multiple hernias were also noted in the midline.These contents were examined and there was no evidence of any bowel injury noted or any problems noted after the lysis of adhesions.¿ implant size and fixation: ¿at this point, the defect was measured and was noted to measure 30 cm x 20 cm gore-tex dual-mesh was then brought into the field.It was transfixed in four corners and then was brought in through the trocar site into the abdomen.It was transfixed onto the abdominal wall in four quadrants to accomplish attachments of the gore to the fascia.It was then circumferentially attached using a protac device to affix the mesh to the abdominal wall.Examination was next done throughout with there being no evidence of any complications or problems.¿ ¿transfixion sutures were then placed around the mesh in a 6 cm circumferential around the mesh to affix this gore-tex.Multiple stab holes were made in the skin, as the sutures were tied.After this was complete, the initial trocar entry site was closed using gore-tex in a figure-of-eight fashion to complete all hernia repairs.¿ relevant medical information: (b)(6) 2009: ct abdomen: ¿there is mesh within the anterior abdominal wall likely from prior hernia repair.¿ (b)(6) 2009: ct abdomen: ¿previous ventral hernia repair.Small right inguinal hernia containing fat.¿ (b)(6) 2011: lost to follow-up.¿very frustrated due to continual abdominal pain at borders of mesh from hernia repair.When he mentioned to surgeon he was told they could take the mesh out which he didn¿t feel was a viable option.¿ ¿exam: abdomen: ttp [tender to palpation] at lateral edges of mesh.¿ surgical referral.¿question adhesions from mess [sic, mesh] vs.Mess [sic, mesh] failure.¿ (b)(6) 13: ¿here for evaluation of left sided lower abdominal pain which started about 3 mos ago when mesh was surgically implanted to repair problems from hernia operations done in the past.The pain has been present intermittently since surgery but would only last up to 15 minutes; pain started today at noon and has been present ever since.¿ ¿had hernia repair by dr.(b)(6) and then subsequent rerepair with mesh by dr.(b)(6).When pt was having problems and went back to see dr.(b)(6) he was told in a very blunt manner ¿well we will just remove it then.¿ pt chose not to follow up with him and has just put up with the discomfort.¿ ¿ruq [right upper quadrant] tenderness and rlq [right lower quadrant] tenderness.¿ ¿no hernia palpable.¿ (b)(6) 2013: ct abdomen: ¿anterior surgical mesh.Right inguinal hernia containing fat.¿ (b)(6) 2014: ct abdomen: ¿misc.-status post ventral hernia repair with at least 3 segments of anterior abdominal wall mesh.Moderate right inguinal hernia is noted containing fatty tissue.¿ ¿ right moderately severe hydroureteronephrosis.¿ (b)(6) 2014: ct abdomen: ¿resolution of right hydronephrosis and hydroureter.Right inguinal canal hernia containing mesenteric fat.¿ (b)(6) 2014: continues to have abdominal pain.¿reports saw surgeon and he did mention pain management, and then discussed surgeons in albany that may be able to operate and go thru mesh to do exploratory surgery but this is very risky.Pt feels frustrated.¿ gastrointestinal [gi] consult for persistent abdominal pain, gas and diarrhea, with negative workup for two months.Evaluate for irritable bowel syndrome.(b)(6) 2014: evaluated for previously repaired hernia.Some pain and tenderness associated with activity.¿there is no evidence of recurrent hernia on palpation or on valsalva.There is no evidence of any other masses.¿ (b)(6) 2014: ct abdomen: ¿two anterior surgical mesh placements.No acute abnormality seen.¿ (b)(6) 2014: chronic diarrhea up to several times daily for 2-3 months.Lost about 30 lbs.¿hpi: unremarkable except has been having a very well localized pain in the right side of his abdominal wall.It feels like a needle poking him for several years, since having mesh implanted in his abdominal wall for a large ventral hernia.¿ ¿patient admits that even the pain on the right side of his mesh which was so sharp before has lessened significantly although he can still feel it.¿ ¿exam: tenderness and a small area of his right midabdomen that he can literally put his finger on.There is no obvious mass in the area that may represent the lateral margins of the mesh.¿ (b)(6) 2016: ct abdomen: ¿there is no prior ventral hernia repair surgical mesh.There is no evidence of recurrence.A small, fat-containing right inguinal hernia is unchanged.¿ explant preoperative complaints: (b)(6) 2016.¿comes in today for evaluation of ongoing problems with bilateral inguinal hernias.It seems that the patient is someone we had seen in the past regarding repair.He has had increasing pain, tenderness, and problems associated with his hernias and had a recent er visit for this.He has had findings on scan consistent with a hernia and was sent for reevaluation.He has had bowel and bladder changes associated with this and has increasing pain, which has been his primary drivers.¿ ¿abdomen: soft.There is a small midline defect which is reducible.There is evidence of recurrence of mass within the right groin.There is no other tenderness.It seems that the patient has both by ct scan and by exam recurrent hernias, which at this point cause more problems.We did discuss with him options for treatment for this.We did discuss with him ongoing changes he may see after surgical intervention.¿ explant procedure: ¿1.Robotic incisional hernia repair with mesh, extraperitoneal tapp [transabdominal preperitoneal] repair with progrip mesh.2.Explantation of old mesh.3.Robotic bilateral indirect inguinal hernia with progrip tapp mesh.4.Lysis of adhesions.¿ explant date: (b)(6) 2016 [hospitalization dates unknown].¿1.Previous hernia repair with a gore-tex mesh with an incarcerated hernia on the inferior portion of the mesh containing small bowel and fat.2.Adhesions of small bowel and omentum to anterior abdominal wall.Lysis of adhesions took approximately 60 minutes.3.Bilateral indirect inguinal hernias.4.Lower midline defect approximately 15 cm in length.5.No complications noted at the termination of the procedure.¿ ¿in the midline of the anterior abdominal wall, there was a large gore-tex mesh, which was secured circumferentially with metal tack.The superior portion of the mesh was intact.However, it appeared that the bottom portion of the mesh towards the patient's pelvis had broken free and there was a hernia containing small bowel and fat in the inferior portion.The mesh at this area was adhered to the bowel and was divided to have access to the hernia contents.Once the mesh was divided, we were able to reduce the contents of the hernia with a combination of sharp dissection and electrocautery.Once the contents were reduced, this piece of mesh was removed off the small bowel carefully with sharp dissection and then passed off the field as specimen.¿ ¿at this point, the gore-tex mesh above the mesh that was still intact was secured to the anterior abdominal wall with a running 0 prolene stitch.The peritoneum was then brought back up over the mesh repair in the pelvis and the bilateral groins up to the gore-tex mesh and secured with a 2-0 stratafix in a continuous fashion to extraperitonealize the mesh repair.Once this was completed, final examination was done of the abdomen.There was good hemostasis noted.¿ (b)(6) 2016: pathology report: ¿specimen: gross examination, explanted mesh.¿ gross description: ¿the specimen received is labeled explanted mesh.The specimen is received in formalin and measures 8.5 x 4.0 x 0.3 cm.The mesh like fragments are attached to multiple coiled metallic rings.¿ ¿final diagnosis: soft tissue, hernia repair: synthetic material consistent with mesh (gross diagnosis only).Adherent fibromembranous tissue with giant cell reaction to foreign material.¿ relevant medical information: (b)(6) 2016: ¿ has been doing overall well since his discharge from the hospital.He has been able to wean himself off his pain medication.He has been returned back to light activity with no major difficulties noted.¿ (b)(6) 2017: ¿pt had a previous abdominal hernia which the mesh had failed in and had to have the whole huge piece replaced.Has had discomfort into the inguinal regions bilaterally and into other areas of the mesh.¿ (b)(6) 2017: ¿ ongoing pain mainly in the right abdomen, which is become more difficult with activities.He is noted no obstructive symptomatology is noted no evidence or any urologic problems with this.Recent cat scan which does show no evidence of recurrent herniation at this site of his complaints on the right side does show intact mesh repair or both in the midline as well as the groins.¿ "i did discuss with him the option of removal of this mesh and movement to a larger procedures such as component separation which would reinforce his entire bowel wall [sic] musculature.Should he not be able to obtain adequate musko skeletal [sic] training to his abdominal wall.This is obviously much more involved procedure with potential increased risks and problems associated with removal is mesh and placement of a new mesh and repair of his abdominal wall with reconstruction.¿ (b)(6) 2017: ct abdomen: ¿mesh within the anterior abdominal wall which is stable.There is an associated midline anterior abdominal wall laxity.There is a right indirect inguinal hernia containing fat, but no bowel.¿ (b)(6) 17: ¿ here for evaluation of across entire mid abdominal wall which has been present for years but had gotten worse in the past month;¿ ¿pt continues to have abdominal pain in a squared off pattern consistent with his mesh from his hernia repair.He had a ct in feb which showed a fatty rih [right inguinal hernia] but no disruption of the mesh.¿ pain on the left side feels like a knife stabbing him when he is seated.The other option was to have to mesh removed.¿ unable to afford recommended physical therapy.(b)(6) 2018: ¿abdominal mesh still bothersome.Has been told he will just have to live with it.¿ it should be noted that the gore® dualmesh® plus biomaterial, instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® plus biomaterial instructions for use also states, ¿cutting gore® dualmesh® plus biomaterial, to the proper size is essential.Use sharp surgical instruments to trim the mesh.If gore® dualmesh® plus biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Based upon the information received, the device remains in the patient and was not available for evaluation.Review of the manufacturing records verified that the lots met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Previous patient codes (1695, 2240, 1994) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Medical records investigation summary: the following information was determined from the medical records.Medical records: known medical records span (b)(6) 2005 through (b)(6) 2018 and not all records received in this time span are relevant to the alleged gore® dualmesh® plus biomaterial, gore® dualmesh® biomaterial, and the gore® dualmesh® plus biomaterial with holes.Medical records from (b)(6) 2006 through (b)(6) 2009; (b)(6) 2009 through (b)(6) 2011; (b)(6) 2011 through (b)(6) 2013, and (b)(6) 2014 through (b)(6) 2016 were not provided.Patient information.Medical history: type ii diabetes.2006: diagnosed.(b)(6) 2011: hgb a1c 8.6 [high].Metformin.Uncontrolled diabetes.Lost to follow-up.(b)(6) 2018: hgb a1c 9.5 [high].Poorly controlled, glucose 226 [high].Glimepiride.(b)(6) 2018: ¿not monitoring home glucose, was out of glimepiride for over one month.¿ gastroesophageal reflux disease [gerd].Hypertension.(b)(6) 2018: ¿does not check blood pressure at home, does not follow low sodium diet.¿ hyperlipidemia.(b)(6) 2018: ¿stopped statin due to cramping.¿ coronary artery disease.Irritable bowel syndrome.Obesity.(b)(6) 2009: 241 lbs., bmi 36.6.(b)(6) 2011: 219 lbs., bmi 33.3.(b)(6) 2014: 212 lbs., bmi: 32.3.(b)(6) 2014: 201 lbs., bmi 30.6.(b)(6) 2018: 208 lbs., bmi 31.6.(b)(6) 2018: 207 lbs., bmi 31.5, ¿weight not at goal.¿ prior surgical procedures: (b)(6) 2005: exploratory laparotomy; probable appendectomy.Unknown date: cholecystectomy.Implant #1 preoperative complaints: none received.Implant #1 procedure: open ventral hernia repair with mesh.Product identification records for the alleged gore device were not provided [¿impregnated dualmesh¿ 10cm x 14 cm].Implant #1 date: (b)(6) 2005 [hospitalization dates unknown].Description of hernia being treated: ¿the previously placed scar was excised, and the hernia sac entered.Adhesions of omentum and the hernia sac were taken down, and the omentum placed back into the abdominal cavity.Only minor adhesions were identified thereafter, but there were a few cicatrices around the small bowel which were divided.The small bowel was run and all adhesions were divided.¿ implant size and fixation: ¿using interrupted #2 nylon and #1 prolene, the gap at both the upper and the lower end was partially closed and a 10x14 cm portion of impregnated dualmesh inserted and secured with interrupted #2 nylon sutures placed in such a fashion that the mesh overlapped the posterior edge of the anterior abdominal wall by at least 3 cm in all areas.In this fashion, the hernia was closed.The tissue immediately superior to the mesh was closed over it with a running 0 vicryl suture.¿ relevant medical information: no medical records provided.Implant #2 preoperative complaints: (b)(6) 2005: ¿ who had undergone an exploratory laparotomy in (b)(6) 2005.After the procedure, he developed a ventral hernia which was repaired using an open technique in (b)(6).The patient presented to the office complaining of persistent pain along the right lower abdomen, just adjacent to the mesh, extending down into the lower pelvis.Ct scan showed a small fascial defect, but no obvious recurrence of the hernia.¿ implant #2 procedure: laparoscopic ventral hernia repair with mesh.Product identification records for the alleged gore device were not provided [¿gore dual mesh¿ 8 cm x 10 cm].Implant #2 date: (b)(6) 2005 [hospitalization dates unknown].Description of hernia being treated: ¿a small recurrent hernia was identified at the superior aspect of the incision over the previous mesh.In the area of the patient¿s most significant tenderness, in the right lower quadrant, there was no evidence of recurrent hernia or other obvious pathology to explain the patient¿s symptoms.¿ ¿blunt dissection was then used to take down several adhesions of omentum to the undersurface of the previous mesh.¿ ¿this same procedure was performed on the left lower quadrant after freeing up several adhesions.Several loops of small bowel were noted to be loosely adherent to the mesh and were taken down using blunt dissection.When all adhesions had been completely removed, the mesh was examined and a small recurrent defect approximately 6 x 6 cm in diameter was noted at the superior aspect of the mesh.¿ implant size and fixation: ¿this was marked on the surface of the skin and a gore dual mesh was cut into oval fashion using an 8 x 10 cm mesh.Anchoring sutures were placed in four quadrants of o gore-tex.This was then rolled into a cigar shape.¿ ¿using the gore needle-passer, the four stay sutures were brought up in four quadrants through small abdominal wall incisions.There were then tied to anchor the mesh.Four other sutures were passed through the abdominal wall through small incisions using a gore needle-passer to further anchor the mesh.The free edges of the mesh were clipped using the wire tacker.At this point, a small bulge was noted just to the right portion of the mesh, just above the umbilicus.This was not a definite fascial defect, but slight laxity was definitely noted.The mesh in this area was approximated to the healthy fascia using interrupted sutures of 0 gore-tex.This was performed using the gore needle-passer.At this point, hemostasis was noted to be complete.¿ relevant medical information: no medical records provided.Implant #3 preoperative complaints: (b)(6) 2006: ¿as you may recall, [the patient].Had previous ventral hernia repairs performed for ongoing recurrent hernias.He initially had these issues start with appendicitis which was explored through a midline incision.Subsequent to this, he has had a recurrent herniation through the site.He has had attempted repairs done by both open and mesh repair approaches.He has been having recurrent pain and tenderness at the site.He most recently had a laparoscopic attempt for repair done in (b)(6) of the past year.Since that time, he has had noted [sic] some fullness and tenderness in the right mid abdomen which is becoming increasingly more prominent for him.He has had bowel changes which has been intermittent in nature.He has been limited on his full activity because of this and wears a binder to help his abdominal wall.¿ "there is a mass in the mid abdomen, which seems reducible and has tenderness associated with it.He has had a previous lower midline, which seems more firm and no evidence of herniation at this point.¿ ¿it seems that [the patient] has questionable recurrence of his hernia in the right upper quadrant.He does have physical findings, which seem consistent with as was his symptomatology.¿ ¿at this point, [the patient] would like to proceed ahead with ventral hernia repair.It seems quite reasonable given his ongoing difficulties and bowel problems that he is having.¿ implant #3 procedure: laparoscopic ventral hernia repair with mesh.Implant: gore® dualmesh® plus biomaterial with holes (1dlmcph07/04107053, 30cm x 20cm) implant #3 date: (b)(6) 2006 [unknown hospitalization dates] description of hernia being treated: ¿adhesions were then noted throughout the midline.An additional port was placed in the left lower quadrant and lysis of adhesions was begun on the left side as mobilization was done of all omental adhesions.Omentum and small bowel were noted to be incarcerated in the hernia and these were reduced with sharp dissection in a circumferential fashion.Complete dissection time was 60 minutes for all lysis of adhesions to remove all contents including omentum and small bowel out of the hernia.Multiple hernias were also noted in the midline.These contents were examined and there was no evidence of any bowel injury noted or any problems noted after the lysis of adhesions.¿ implant size and fixation: ¿at this point, the defect was measured and was noted to measure 30 cm x 20 cm gore-tex dual-mesh was then brought into the field.It was transfixed in four corners and then was brought in through the trocar site into the abdomen.It was transfixed onto the abdominal wall in four quadrants to accomplish attachments of the gore to the fascia.It was then circumferentially attached using a protac device to affix the mesh to the abdominal wall.Examination was next done throughout with there being no evidence of any complications or problems.¿ ¿transfixion sutures were then placed around the mesh in a 6 cm circumferential around the mesh to affix this gore-tex.Multiple stab holes were made in the skin, as the sutures were tied.After this was complete, the initial trocar entry site was closed using gore-tex in a figure-of-eight fashion to complete all hernia repairs.¿ relevant medical information: (b)(6) 2009: ct abdomen: ¿there is mesh within the anterior abdominal wall likely from prior hernia repair.¿ (b)(6) 2009: ct abdomen: ¿previous ventral hernia repair.Small right inguinal hernia containing fat.¿ (b)(6) 2011: lost to follow-up.¿very frustrated due to continual abdominal pain at borders of mesh from hernia repair.When he mentioned to surgeon he was told they could take the mesh out which he didn¿t feel was a viable option.¿ ¿exam: abdomen: ttp [tender to palpation] at lateral edges of mesh.¿ surgical referral.¿question adhesions from mess [sic, mesh] vs.Mess [sic, mesh] failure.¿ (b)(6) 2013: ¿here for evaluation of left sided lower abdominal pain which started about 3 mos ago when mesh was surgically implanted to repair problems from hernia operations done in the past.The pain has been present intermittently since surgery but would only last up to 15 minutes; pain started today at noon and has been present ever since.¿ ¿had hernia repair by dr.(b)(6) and then subsequent rerepair with mesh by dr.(b)(6) in (b)(6).When pt was having problems and went back to see dr.(b)(6) he was told in a very blunt manner ¿well we will just remove it then.¿ pt chose not to follow up with him and has just put up with the discomfort.¿ ¿ruq [right upper quadrant] tenderness and rlq [right lower quadrant] tenderness.¿ ¿no hernia palpable.¿ (b)(6) 2013: ct abdomen: ¿anterior surgical mesh.Right inguinal hernia containing fat.¿ (b)(6) 2014: ct abdomen: ¿misc.-status post ventral hernia repair with at least 3 segments of anterior abdominal wall mesh.Moderate right inguinal hernia is noted containing fatty tissue.¿ ¿ right moderately severe hydroureteronephrosis.¿ (b)(6) 2014: ct abdomen: ¿resolution of right hydronephrosis and hydroureter.Right inguinal canal hernia containing mesenteric fat.¿ (b)(6) 2014: continues to have abdominal pain.¿reports saw surgeon and he did mention pain management, and then discussed surgeons in albany that may be able to operate and go thru mesh to do exploratory surgery but this is very risky.Pt feels frustrated.¿ gastrointestinal [gi] consult for persistent abdominal pain, gas and diarrhea, with negative workup for two months.Evaluate for irritable bowel syndrome.(b)(6) 2014: evaluated for previously repaired hernia.Some pain and tenderness associated with activity.¿there is no evidence of recurrent hernia on palpation or on valsalva.There is no evidence of any other masses.¿ (b)(6) 2014: ct abdomen: ¿two anterior surgical mesh placements.No acute abnormality seen.¿ (b)(6) 2014: chronic diarrhea up to several times daily for 2-3 months.Lost about 30 lbs.¿hpi: unremarkable except has been having a very well localized pain in the right side of his abdominal wall.It feels like a needle poking him for several years, since having mesh implanted in his abdominal wall for a large ventral hernia.¿ ¿patient admits that even the pain on the right side of his mesh which was so sharp before has lessened significantly although he can still feel it.¿ ¿exam: tenderness and a small area of his right midabdominal that he can literally put his finger on.There is no obvious mass in the area that may represent the lateral margins of the mesh.¿ (b)(6) 2016: ct abdomen: ¿there is no prior ventral hernia repair surgical mesh.There is no evidence of recurrence.A small, fat-containing right inguinal hernia is unchanged.¿ explant preoperative complaints: (b)(6) 2016: ¿comes in today for evaluation of ongoing problems with bilateral inguinal hernias.It seems that the patient is someone we had seen in the past regarding repair.He has had increasing pain, tenderness, and problems associated with his hernias and had a recent er visit for this.He has had findings on scan consistent with a hernia and was sent for reevaluation.He has had bowel and bladder changes associated with this and has increasing pain, which has been his primary drivers.¿ ¿abdomen: soft.There is a small midline defect which is reducible.There is evidence of recurrence of mass within the right groin.There is no other tenderness.It seems that the patient has both by ct scan and by exam recurrent hernias, which at this point cause more problems.We did discuss with him options for treatment for this.We did discuss with him ongoing changes he may see after surgical intervention.¿ explant procedure: ¿1.Robotic incisional hernia repair with mesh, extraperitoneal tapp [transabdominal preperitoneal] repair with progrip mesh.2.Explantation of old mesh.3.Robotic bilateral indirect inguinal hernia with progrip tapp mesh.4.Lysis of adhesions.¿ explant date: (b)(6) 2016 [hospitalization dates unknown].¿1.Previous hernia repair with a gore-tex mesh with an incarcerated hernia on the inferior portion of the mesh containing small bowel and fat.2.Adhesions of small bowel and omentum to anterior abdominal wall.Lysis of adhesions took approximately 60 minutes.3.Bilateral indirect inguinal hernias.4.Lower midline defect approximately 15 cm in length.5.No complications noted at the termination of the procedure.¿ ¿in the midline of the anterior abdominal wall, there was a large gore-tex mesh, which was secured circumferentially with metal tack.The superior portion of the mesh was intact.However, it appeared that the bottom portion of the mesh towards the patient's pelvis had broken free and there was a hernia containing small bowel and fat in the inferior portion.The mesh at this area was adhered to the bowel and was divided to have access to the hernia contents.Once the mesh was divided, we were able to reduce the contents of the hernia with a combination of sharp dissection and electrocautery.Once the contents were reduced, this piece of mesh was removed off the small bowel carefully with sharp dissection and then passed off the field as specimen.¿ ¿at this point, the gore-tex mesh above the mesh that was still intact was secured to the anterior abdominal wall with a running 0 prolene stitch.The peritoneum was then brought back up over the mesh repair in the pelvis and the bilateral groins up to the gore-tex mesh and secured with a 2-0 stratafix in a continuous fashion to extraperitonealis the mesh repair.Once this was completed, final examination was done of the abdomen.There was good hemostasis noted.¿ (b)(6) 2016: pathology report: ¿specimen: gross examination, explanted mesh.¿ gross description: ¿the specimen received is labeled explanted mesh.The specimen is received in formalin and measures 8.5 x 4.0 x 0.3 cm.The mesh like fragments are attached to multiple coiled metallic rings.¿ ¿final diagnosis: soft tissue, hernia repair: synthetic material consistent with mesh (gross diagnosis only).Adherent fibromembranous tissue with giant cell reaction to foreign material.¿ relevant medical information: (b)(6) 2016: ¿has been doing overall well since his discharge from the hospital.He has been able to wean himself off his pain medication.He has been returned back to light activity with no major difficulties noted.¿ (b)(6) 2017: ¿pt had a previous abdominal hernia which the mesh had failed in and had to have the whole huge piece replaced.Has had discomfort into the inguinal regions bilaterally and into other areas of the mesh.¿ (b)(6) 2017: ¿ongoing pain mainly in the right abdomen, which is become more difficult with activities.He is noted no obstructive symptomatology is noted no evidence or any urologic problems with this.Recent cat scan which does show no evidence of recurrent herniation at this site of his complaints on the right side does show intact mesh repair or both in the midline as well as the groins.¿ "i did discuss with him the option of removal of this mesh and movement to a larger procedures such as component separation which would reinforce his entire bowel wall [sic] musculature.Should he not be able to obtain adequate musko skeletal [sic] training to his abdominal wall.This is obviously much more involved procedure with potential increased risks and problems associated with removal is mesh and placement of a new mesh and repair of his abdominal wall with reconstruction.¿ (b)(6) 2017: ct abdomen: ¿mesh within the anterior abdominal wall which is stable.There is an associated midline anterior abdominal wall laxity.There is a right indirect inguinal hernia containing fat, but no bowel.¿ (b)(6) 2017: ¿here for evaluation of across entire mid abdominal wall which has been present for years but had gotten worse in the past month;¿ ¿pt continues to have abdominal pain in a squared off pattern consistent with his mesh from his hernia repair.He had a ct in feb which showed a fatty rih [right inguinal hernia] but no disruption of the mesh.¿ pain on the left side feels like a knife stabbing him when he is seated.The other option was to have to mesh removed.¿ unable to afford recommended physical therapy.(b)(6) 2018: ¿abdominal mesh still bothersome.Has been told he will just have to live with it.¿ it should be noted that the gore® dualmesh® plus biomaterial, instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® plus biomaterial instructions for use also states, ¿cutting gore® dualmesh® plus biomaterial, to the proper size is essential.Use sharp surgical instruments to trim the mesh.If gore® dualmesh® plus biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Based upon the information received, the device remains in the patient and was not available for evaluation.Review of the manufacturing records verified that the lots met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Previous patient codes (1695, 2240, 1994) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Medical records investigation summary: the following information was determined from the medical records.Medical records: known medical records span (b)(6) 2005 through (b)(6) 2018 and not all records received in this time span are relevant to the alleged gore® dualmesh® plus biomaterial, gore® dualmesh® biomaterial, and the gore® dualmesh® plus biomaterial with holes.Medical records from (b)(6) 2006 through (b)(6) 2009; (b)(6) 2009 through (b)(6) 2011; (b)(6) 2011 through (b)(6) 2013, and (b)(6) 2014 through (b)(6) 2016 were not provided.Patient information.Medical history: type ii diabetes.2006: diagnosed.(b)(6) 2011: hgb a1c 8.6 [high].Metformin.Uncontrolled diabetes.Lost to follow-up.(b)(6) 2018: hgb a1c 9.5 [high].Poorly controlled, glucose 226 [high].Glimepiride.(b)(6) 2018: ¿not monitoring home glucose, was out of glimepiride for over one month.¿ gastroesophageal reflux disease [gerd].Hypertension.(b)(6) 2018: ¿does not check blood pressure at home, does not follow low sodium diet.¿ hyperlipidemia.(b)(6) 2018: ¿stopped statin due to cramping.¿ coronary artery disease.Irritable bowel syndrome.Obesity.(b)(6) 2009: 241 lbs., bmi 36.6.(b)(6) 2011: 219 lbs., bmi 33.3.(b)(6) 2014: 212 lbs., bmi: 32.3.(b)(6) 2014: 201 lbs., bmi 30.6.(b)(6) 2018: 208 lbs., bmi 31.6.(b)(6) 2018: 207 lbs., bmi 31.5, ¿weight not at goal.¿ prior surgical procedures: (b)(6) 2005: exploratory laparotomy; probable appendectomy.Unknown date: cholecystectomy implant #1 preoperative complaints: none received.Implant #1 procedure: open ventral hernia repair with mesh.Product identification records for the alleged gore device were not provided [¿impregnated dualmesh¿ 10cm x 14 cm].Implant #1 date: (b)(6) 2005 [hospitalization dates unknown].Description of hernia being treated: ¿the previously placed scar was excised, and the hernia sac entered.Adhesions of omentum and the hernia sac were taken down, and the omentum placed back into the abdominal cavity.Only minor adhesions were identified thereafter, but there were a few cicatrices around the small bowel which were divided.The small bowel was run and all adhesions were divided.¿ implant size and fixation: ¿using interrupted #2 nylon and #1 prolene, the gap at both the upper and the lower end was partially closed and a 10x14 cm portion of impregnated dualmesh inserted and secured with interrupted #2 nylon sutures placed in such a fashion that the mesh overlapped the posterior edge of the anterior abdominal wall by at least 3 cm in all areas.In this fashion, the hernia was closed.The tissue immediately superior to the mesh was closed over it with a running 0 vicryl suture.¿ relevant medical information: no medical records provided.Implant #2 preoperative complaints: (b)(6) 2005: ¿ who had undergone an exploratory laparotomy in (b)(6) 2005.After the procedure, he developed a ventral hernia which was repaired using an open technique in (b)(6).The patient presented to the office complaining of persistent pain along the right lower abdomen, just adjacent to the mesh, extending down into the lower pelvis.Ct scan showed a small fascial defect, but no obvious recurrence of the hernia.¿ implant #2 procedure: laparoscopic ventral hernia repair with mesh.Product identification records for the alleged gore device were not provided [¿gore dual mesh¿ 8 cm x 10 cm].Implant #2 date: (b)(6) 2005 [hospitalization dates unknown].Description of hernia being treated: ¿a small recurrent hernia was identified at the superior aspect of the incision over the previous mesh.In the area of the patient¿s most significant tenderness, in the right lower quadrant, there was no evidence of recurrent hernia or other obvious pathology to explain the patient¿s symptoms.¿ ¿blunt dissection was then used to take down several adhesions of omentum to the undersurface of the previous mesh.¿ ¿this same procedure was performed on the left lower quadrant after freeing up several adhesions.Several loops of small bowel were noted to be loosely adherent to the mesh and were taken down using blunt dissection.When all adhesions had been completely removed, the mesh was examined and a small recurrent defect approximately 6 x 6 cm in diameter was noted at the superior aspect of the mesh.¿ implant size and fixation: ¿this was marked on the surface of the skin and a gore dual mesh was cut into oval fashion using an 8 x 10 cm mesh.Anchoring sutures were placed in four quadrants of o gore-tex.This was then rolled into a cigar shape.¿ ¿using the gore needle-passer, the four stay sutures were brought up in four quadrants through small abdominal wall incisions.There were then tied to anchor the mesh.Four other sutures were passed through the abdominal wall through small incisions using a gore needle-passer to further anchor the mesh.The free edges of the mesh were clipped using the wire tacker.At this point, a small bulge was noted just to the right portion of the mesh, just above the umbilicus.This was not a definite fascial defect, but slight laxity was definitely noted.The mesh in this area was approximated to the healthy fascia using interrupted sutures of 0 gore-tex.This was performed using the gore needle-passer.At this point, hemostasis was noted to be complete.¿ relevant medical information: no medical records provided.Implant #3 preoperative complaints: (b)(6) 2006: ¿as you may recall, [the patient].Had previous ventral hernia repairs performed for ongoing recurrent hernias.He initially had these issues start with appendicitis which was explored through a midline incision.Subsequent to this, he has had a recurrent herniation through the site.He has had attempted repairs done by both open and mesh repair approaches.He has been having recurrent pain and tenderness at the site.He most recently had a laparoscopic attempt for repair done in (b)(6) of the past year.Since that time, he has had noted [sic] some fullness and tenderness in the right mid abdomen which is becoming increasingly more prominent for him.He has had bowel changes which has been intermittent in nature.He has been limited on his full activity because of this and wears a binder to help his abdominal wall.¿ "there is a mass in the mid abdomen, which seems reducible and has tenderness associated with it.He has had a previous lower midline, which seems more firm and no evidence of herniation at this point.¿ ¿it seems that [the patient] has questionable recurrence of his hernia in the right upper quadrant.He does have physical findings, which seem consistent with as was his symptomatology.¿ ¿at this point, [the patient] would like to proceed ahead with ventral hernia repair.It seems quite reasonable given his ongoing difficulties and bowel problems that he is having.¿ implant #3 procedure: laparoscopic ventral hernia repair with mesh.Implant: gore® dualmesh® plus biomaterial with holes (1dlmcph07/04107053, 30cm x 20cm).Implant #3 date: (b)(6) 2006 [unknown hospitalization dates].Description of hernia being treated: ¿adhesions were then noted throughout the midline.An additional port was placed in the left lower quadrant and lysis of adhesions was begun on the left side as mobilization was done of all omental adhesions.Omentum and small bowel were noted to be incarcerated in the hernia and these were reduced with sharp dissection in a circumferential fashion.Complete dissection time was 60 minutes for all lysis of adhesions to remove all contents including omentum and small bowel out of the hernia.Multiple hernias were also noted in the midline.These contents were examined and there was no evidence of any bowel injury noted or any problems noted after the lysis of adhesions.¿ implant size and fixation: ¿at this point, the defect was measured and was noted to measure 30 cm x 20 cm gore-tex dual-mesh was then brought into the field.It was transfixed in four corners and then was brought in through the trocar site into the abdomen.It was transfixed onto the abdominal wall in four quadrants to accomplish attachments of the gore to the fascia.It was then circumferentially attached using a protac device to affix the mesh to the abdominal wall.Examination was next done throughout with there being no evidence of any complications or problems.¿ ¿transfixion sutures were then placed around the mesh in a 6 cm circumferential around the mesh to affix this gore-tex.Multiple stab holes were made in the skin, as the sutures were tied.After this was complete, the initial trocar entry site was closed using gore-tex in a figure-of-eight fashion to complete all hernia repairs.¿ relevant medical information: (b)(6) 2009: ct abdomen: ¿there is mesh within the anterior abdominal wall likely from prior hernia repair.¿ (b)(6) 2009: ct abdomen: ¿previous ventral hernia repair.Small right inguinal hernia containing fat.¿ b)(6) 2011: lost to follow-up.¿very frustrated due to continual abdominal pain at borders of mesh from hernia repair.When he mentioned to surgeon he was told they could take the mesh out which he didn¿t feel was a viable option.¿ ¿exam: abdomen: ttp [tender to palpation] at lateral edges of mesh.¿ surgical referral.¿question adhesions from mess [sic, mesh] vs.Mess [sic, mesh] failure.¿ (b)(6) 2013: ¿here for evaluation of left sided lower abdominal pain which started about 3 mos ago when mesh was surgically implanted to repair problems from hernia operations done in the past.The pain has been present intermittently since surgery but would only last up to 15 minutes; pain started today at noon and has been present ever since.¿ ¿had hernia repair by dr.(b)(6) and then subsequent rerepair with mesh by dr.(b)(6) in (b)(6).When pt was having problems and went back to see dr.(b)(6) he was told in a very blunt manner ¿well we will just remove it then.¿ pt chose not to follow up with him and has just put up with the discomfort.¿ ¿ruq [right upper quadrant] tenderness and rlq [right lower quadrant] tenderness.¿ ¿no hernia palpable.¿ (b)(6) 2013: ct abdomen: ¿anterior surgical mesh.Right inguinal hernia containing fat.¿ (b)(6) 2014: ct abdomen: ¿misc.-status post ventral hernia repair with at least 3 segments of anterior abdominal wall mesh.Moderate right inguinal hernia is noted containing fatty tissue.¿ ¿ right moderately severe hydroureteronephrosis.¿ (b)(6) 2014: ct abdomen: ¿resolution of right hydronephrosis and hydroureter.Right inguinal canal hernia containing mesenteric fat.¿ (b)(6) 2014: continues to have abdominal pain.¿reports saw surgeon and he did mention pain management, and then discussed surgeons in albany that may be able to operate and go thru mesh to do exploratory surgery but this is very risky.Pt feels frustrated.¿ gastrointestinal [gi] consult for persistent abdominal pain, gas and diarrhea, with negative workup for two months.Evaluate for irritable bowel syndrome.(b)(6) 2014: evaluated for previously repaired hernia.Some pain and tenderness associated with activity.¿there is no evidence of recurrent hernia on palpation or on valsalva.There is no evidence of any other masses.¿ (b)(6) 2014: ct abdomen: ¿two anterior surgical mesh placements.No acute abnormality seen.¿ (b)(6) 2014: chronic diarrhea up to several times daily for 2-3 months.Lost about 30 lbs.¿hpi: unremarkable except has been having a very well localized pain in the right side of his abdominal wall.It feels like a needle poking him for several years, since having mesh implanted in his abdominal wall for a large ventral hernia.¿ ¿patient admits that even the pain on the right side of his mesh which was so sharp before has lessened significantly although he can still feel it.¿ ¿exam: tenderness and a small area of his right midabdominal that he can literally put his finger on.There is no obvious mass in the area that may represent the lateral margins of the mesh.¿ (b)(6) 2016: ct abdomen: ¿there is no prior ventral hernia repair surgical mesh.There is no evidence of recurrence.A small, fat-containing right inguinal hernia is unchanged.¿ explant preoperative complaints: (b)(6) 2016: ¿comes in today for evaluation of ongoing problems with bilateral inguinal hernias.It seems that the patient is someone we had seen in the past regarding repair.He has had increasing pain, tenderness, and problems associated with his hernias and had a recent er visit for this.He has had findings on scan consistent with a hernia and was sent for reevaluation.He has had bowel and bladder changes associated with this and has increasing pain, which has been his primary drivers.¿ ¿abdomen: soft.There is a small midline defect which is reducible.There is evidence of recurrence of mass within the right groin.There is no other tenderness.It seems that the patient has both by ct scan and by exam recurrent hernias, which at this point cause more problems.We did discuss with him options for treatment for this.We did discuss with him ongoing changes he may see after surgical intervention.¿ explant procedure: ¿1.Robotic incisional hernia repair with mesh, extraperitoneal tapp [transabdominal preperitoneal] repair with progrip mesh.2.Explantation of old mesh.3.Robotic bilateral indirect inguinal hernia with progrip tapp mesh.4.Lysis of adhesions.¿ explant date: (b)(6) 2016 [hospitalization dates unknown].¿1.Previous hernia repair with a gore-tex mesh with an incarcerated hernia on the inferior portion of the mesh containing small bowel and fat.2.Adhesions of small bowel and omentum to anterior abdominal wall.Lysis of adhesions took approximately 60 minutes.3.Bilateral indirect inguinal hernias.4.Lower midline defect approximately 15 cm in length.5.No complications noted at the termination of the procedure.¿ ¿in the midline of the anterior abdominal wall, there was a large gore-tex mesh, which was secured circumferentially with metal tack.The superior portion of the mesh was intact.However, it appeared that the bottom portion of the mesh towards the patient's pelvis had broken free and there was a hernia containing small bowel and fat in the inferior portion.The mesh at this area was adhered to the bowel and was divided to have access to the hernia contents.Once the mesh was divided, we were able to reduce the contents of the hernia with a combination of sharp dissection and electrocautery.Once the contents were reduced, this piece of mesh was removed off the small bowel carefully with sharp dissection and then passed off the field as specimen.¿ ¿at this point, the gore-tex mesh above the mesh that was still intact was secured to the anterior abdominal wall with a running 0 prolene stitch.The peritoneum was then brought back up over the mesh repair in the pelvis and the bilateral groins up to the gore-tex mesh and secured with a 2-0 stratafix in a continuous fashion to extraperitonealize the mesh repair.Once this was completed, final examination was done of the abdomen.There was good hemostasis noted.¿ (b)(6) 2016: pathology report: ¿specimen: gross examination, explanted mesh.¿ gross description: ¿the specimen received is labeled explanted mesh.The specimen is received in formalin and measures 8.5 x 4.0 x 0.3 cm.The mesh like fragments are attached to multiple coiled metallic rings.¿ ¿final diagnosis: soft tissue, hernia repair: synthetic material consistent with mesh (gross diagnosis only).Adherent fibromembranous tissue with giant cell reaction to foreign material.¿ relevant medical information: (b)(6) 2016: ¿ has been doing overall well since his discharge from the hospital.He has been able to wean himself off his pain medication.He has been returned back to light activity with no major difficulties noted.¿ (b)(6) 2017: ¿pt had a previous abdominal hernia which the mesh had failed in and had to have the whole huge piece replaced.Has had discomfort into the inguinal regions bilaterally and into other areas of the mesh.¿ (b)(6) 2017: ¿ ongoing pain mainly in the right abdomen, which is become more difficult with activities.He is noted no obstructive symptomatology is noted no evidence or any urologic problems with this.Recent cat scan which does show no evidence of recurrent herniation at this site of his complaints on the right side does show intact mesh repair or both in the midline as well as the groins.¿ "i did discuss with him the option of removal of this mesh and movement to a larger procedures such as component separation which would reinforce his entire bowel wall [sic] musculature.Should he not be able to obtain adequate musko skeletal [sic] training to his abdominal wall.This is obviously much more involved procedure with potential increased risks and problems associated with removal is mesh and placement of a new mesh and repair of his abdominal wall with reconstruction.¿ (b)(6) 2017: ct abdomen: ¿mesh within the anterior abdominal wall which is stable.There is an associated midline anterior abdominal wall laxity.There is a right indirect inguinal hernia containing fat, but no bowel.¿ (b)(6) 2017: ¿here for evaluation of across entire mid abdominal wall which has been present for years but had gotten worse in the past month;¿ ¿pt continues to have abdominal pain in a squared off pattern consistent with his mesh from his hernia repair.He had a ct in feb which showed a fatty rih [right inguinal hernia] but no disruption of the mesh.¿ pain on the left side feels like a knife stabbing him when he is seated.The other option was to have to mesh removed.¿ unable to afford recommended physical therapy.(b)(6) 2018: ¿abdominal mesh still bothersome.Has been told he will just have to live with it.¿ it should be noted that the gore® dualmesh® plus biomaterial, instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® plus biomaterial instructions for use also states, ¿cutting gore® dualmesh® plus biomaterial, to the proper size is essential.Use sharp surgical instruments to trim the mesh.If gore® dualmesh® plus biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Based upon the information received, the device remains in the patient and was not available for evaluation.Review of the manufacturing records verified that the lots met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.Section c1: name: plus antimicrobial product coating.  manufacturer/compounder: w.L.Gore & associates, inc.  lot number unk.Additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].  w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE DUALMESH BIOMATERIAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7641566
• MDR Text Key: 112453855
• Report Number: 2017233-2018-00354
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K992189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/13/2018; 01/07/2019; 02/01/2019; 02/11/2019; 04/02/2019; 05/01/2019; 02/25/2020; 07/24/2020; 08/03/2020; 08/27/2020; 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 109