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| Catalog Number 1DLMP03 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Pain (1994); Hernia (2240); Not Applicable (3189); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.¿.
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Event Description
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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 1999, whereby a gore dualmesh® plus biomaterial was implanted.It was reported to gore that the patient underwent hernia repair (type unknown) on (b)(6) 2001, whereby a gore dualmesh® plus biomaterial was implanted.It was reported the patient alleges the following injuries: hernia recurrence, additional surgery, mesh failure, pain.Additional event specific information was not provided.
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Manufacturer Narrative
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Added explant date.Conclusion code remains unchanged.
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Manufacturer Narrative
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Updated result code.Conclusion code remains unchanged.
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Manufacturer Narrative
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Please note the initial medwatch indicates an incorrect date gore aware of 11/12/2018.The date gore aware of information for the initial report is 11/10/2018.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: records prior to 11/5/1999, including records for any prior abdominal procedures, were not provided.Medical records dated 11/5/1999 state: ¿this 32 year old female presents with evidence of reducible swelling in the right upper quadrant of the abdomen and on the examination, evidence of a reducible incisional hernia.The patient has had two prior right upper quadrant abdominal surgical incisions at the site of cholecystectomy and sphincteroplasty.She has also undergone a right nephrectomy and the herniation appears to be present near the confluence of these two areas.The patient has had nothing to suggest nausea, vomiting, obstipation, distention or suggestion of incarceration or strangulation.¿ the medical records dated 11/5/1999 continue: ¿the patient has had marked difficulty with a prior repair of an incisional hernia in the right upper quadrant at the site of placement of the mesh.The mesh was removed and the wound was reconstructed several times.¿ records for the previous hernia repair and mesh removal were not provided.Operative records dated 11/5/1999 state the patient underwent ventral incisional herniorrhaphy employing gortex duofilm mesh.The patient is ¿a 32 year old female presents with symptoms of a reducible swelling near the confluence of a right flank incision and a right upper quadrant incision at the site of a previous cholecystectomy and renal surgery on the right.There appears to be a defect in the fascia covering the area.The patient has local pain and tenderness.There had been no history suggesting incarceration or strangulation.¿ the operative records dated 11/5/1999 state: ¿an oblique incision was made in the axis of the lateral portion of the right subcostal scar.This was carried into the confluence of the right subcostal scar with the right flank scar.The external and inferior oblique muscles were elevated at this time.The peritoneum was then reflected off the musculature and off the rectus muscle more medially.¿ records dated 11/5/1999 continue: ¿upon completion of this then the gortex duofilm, 10 by 15 cm, mesh with the proper orientation was placed into the defect.This was sutured about the margins of the defect beneath the muscle employing a running 0 prolene.Portions of the gortex were trimmed to fit the size of the defect itself.Upon completion of this then the area appeared to be adequately stabilized in the defect.The muscle and fascia were closed over the duofilm mesh employing interrupted 0 ethibond near-and-far sutures.The subcutaneous fat was almost nonexistent and the skin was closed with a running 3-0 subcuticular absorbable suture.Upon completion of this then the wound was steri-stripped.¿ the records confirm a gore dualmesh® plus biomaterial (1dlmc03/p14989-005) was used during the procedure.Operative records dated 8/31/2000 indicate the patient underwent direct suspension microscopic laryngoscopy with multiple biopsies for complaint of persistent hoarseness.Operative records dated 3/30/2001 state the patient underwent repair of recurrent ventral incisional hernia; gore-tex mesh.¿this 34-year-old female had in november of 1999 undergone a repair of a ventral incisional hernia at the confluence of a cholecystectomy and right nephrectomv wound.The patient had had dual-mesh placed.The patient had demonstrated relief of symptoms following the repair and had done well until approximately several weeks prior at which time she noted the onset of a reducible swelling in the area of the previous repair.The patient states that she had been involved in significant lifting and straining.She noted significant local pain and tenderness.The patient, on examination, was found to have a bulge and significant weakness in the same area.¿ operative records dated 3/30/2001 state: ¿an incision was made in the right subcostal plane and then carried laterally along the old nephrectomy wound.With this then, the upper flap was reflected to the chest wall superiorly and inferiorly along the abdominal wall and along the area of the right flank.Following completion of this then, the muscle which was markedly attenuated was then incised.This raised a flap superiorly which was myofascial.The fascia was very weak and some of the peritoneal area was bulging through.¿ the records dated 3/30/2001 continue: ¿following completion of this then, the gore-tex dual-film with the proper orientation was placed into the incision and sutured in place employing #1 prolene mattress sutures.Kefzol solution was irrigated over the gore-tex graft and the gore-tex had been previously soaked in the 2% kefzol solution.Following completion of this then, the myofascial layer was closed over the gore-tex employing 0 ethibond suture.Following completion of this then, the skin was closed with interrupted 3-0 silk deep vertical mattress sutures.Steri-strips and a tegaderm dressing are applied.¿ the records confirm a gore dualmesh® plus biomaterial (1dlmc03/00561995) was used during the procedure.There was no mention of the dualmesh® implanted in 1999 in the records, and no mention of device removal.Operative records dated 8/12/2002 state the patient underwent appendectomy.There is no mention of gore dualmesh® plus biomaterial in the records.Operative records dated 1/9/2003 state the patient underwent laparoscopy, drainage of paratubal cysts, lysis of adhesions and right partial salpingectomy.The records state: ¿¿the remainder of the upper abdomen essentially appeared to be normal.¿ there is no mention of gore dualmesh® plus biomaterial in the records.Operative records dated 3/14/2003 state the patient underwent excision of appendiceal stump and total abdominal hysterectomy with bilateral oopho-salpingectomy.There is no mention of gore dualmesh® plus biomaterial in the records.Operative/procedure records dated 9/8/2004 state the patient underwent operative esophagogastroduodenoscopic examination with biopsies of the duodenum, gastric antrum, and gastroesophageal junction.Postoperative diagnosis: small superficial duodenal ulceration healing, antral gastritis, mild peptic esophagitis, small hiatal hernia.Operative reports dated 3/16/2005 state the patient underwent excision and biopsy of palpable nodule, upper outer quadrant right breast.Diagnosis: benign breast tissue, malignancy is not present.Operative records dated 2/23/2006 state the patient underwent incisional hernia repair with mesh placement.¿this is a 39-year-old patient.She presented to me with complaint of right-sided abdominal wall incisional hernia.She has had a previous nephrectomy as well as cholecystectomy and where the 2 incisions meet, she has noticed a bulge and pain.¿ the operative records dated 2/23/2006 state: ¿an incision was made along the previous nephrectomy line and the subcutaneous tissue was dissected down.There was a previous hernia repair with a mesh placement in this region.There was recurrence at the junction of the cholecystectomy incision and the nephrectomy incision.It was decided to repair this with an onlay mesh.¿ the records dated 2/23/2006 continue: ¿a 4- x 6-inch piece of mesh was selected and the size was used to judge the clearing of the fascia.The fascia was cleared for a similar area around the hernia defect.Hernia defect itself was about 2 cm in size.The mesh was sewn anteriorly on the abdominal wall using 0 interrupted surgidac sutures.This was done in a circumferential fashion.There were no gaps noted in the mesh.The mesh was then irrigated and the subcutaneum was closed using a 3-0 vicryl suture.Skin was then closed using surgical staples.¿ the records indicate a marlex mesh (non-gore device) was implanted during the procedure.There was no mention of the gore devices in the records and no mention of device removal.Operative records dated 3/20/2006 state the patient underwent incision and drainage of abdominal wall abscess and removal of infected mesh in the abdominal wall.The patient ¿is a 39-year-old female.She has a history of hernia repair back in february 2006 by myself in the anterior abdominal wall.She underwent a primary repair with reinforcement of a mesh which is a marlex type mesh on the anterior abdominal wall.Polypropylene mesh has now become infected and she has a large abscess cavity in the abdominal wall.¿ the operative records dated 3/20/2006 state: ¿an incision was made with the 10 blade scalpel over the previous incision.The subcutaneous tissues were immediately entered and a large purulent debris was expressed.Cultures were sent for gram stain as well as culture and sensitivity.Because of the malodorous emission from the wound, it was thought that the wound was certainly infected and that the mesh should be removed.There was some filmy bile and exudated material along the mesh.This was removed along with the entire mesh.¿ the records dated 3/20/2006 continue: ¿the mesh was cut off from the abdominal wall and came out from the abdominal fascia fairly readily.There was a small resulting hernia defect and this was suture closed using 0 vicryl suture.The area was then fairly irrigated out and any remaining surgidac suture was removed from the mesh and from the abdominal wall.The mesh was sent for culture as well.The wound was then closed by inserting a blake drain through a separate stab incision, and the skin was closed in a single layer using surgical staples.The drain was connected to suction.Prior to closure, the wound was thoroughly irrigated out using approximately a liter of normal saline which was sterile.¿ it is unclear from the records which mesh was removed during the procedure.There was no mention of the gore devices in the records.Pathology and culture reports for the explanted mesh and swabs taken during the 3/20/2006 procedure were not provided.Operative records dated 10/19/2006 state the patient underwent incisional hernia repair.The patient ¿is a 39 -year-old female.She has a history of right upper quadrant abdominal pain and bulge.She has a history of multiple incisional hernias in the past and now has a new incisional hernia at the area of her laparoscopic port site from previous surgery¿ the operative records dated 10/19/2006 state: ¿the right upper quadrant was palpated, and the area of hernia was identified.A transverse incision was made in a kocher style fashion until the subcutaneous tissues were identified.There was a small hernia which was approximately 1.5 cm in total size with a small hernia sac.This was imbricated primarily and closed using o interrupted surgidac sutures with good healthy fascia on either side.This was really close to the edge of the rib, so some of the fascia over the ribcage was brought down for closure.¿ the operative records dated 10/19/2006 state: ¿once the area was completely closed, the skin was irrigated out and closed using surgical staples.The wound was dressed using telfa and gauze.¿ there was no mention of the gore devices in the records and no mention of device removal.Operative records dated 7/19/2007 state the patient underwent excision of suture granuloma of the anterior abdominal wall.The patient ¿is a 40 -year-old female.She has had multiple surgery of the abdominal wall including multiple hernia repairs.She was noted to have a recent right upper quadrant enlarging mass which has been very tender for her.She has not had any associated fever, redness or drainage.It was questionable as to whether or not this is a recurrent hernia versus a suture granuloma or mesh related problem.¿ the operative records dated 7/19/2007 continue: ¿a right upper quadrant incision was made using a 10-blade scalpel.The subcutaneous tissues was dissected down until the palpable mass was encountered.It was carefully entered and there was purulent debris inside.It was cultured although i believe this was most likely secondary to sterile pyogenic granuloma as there was noted to be suture material at the base of the abscess cavity.¿ the records dated 7/19/2007 state: ¿the suture was completely removed and it appeared to be braided 0 -tycrons.The area around the capsule was excised using the bovie pencil and sent to pathology.The remaining area was then irrigated out.Fascia was not violated during the procedure.The subcutaneous was closed using a 3-0 running vicryl suture.The skin was then approximated using surgical staples.¿ there is no mention of gore dualmesh® plus biomaterial in the records.Pathology report dated 7/19/2007 states: ¿suture granuloma, negative for neoplasia.A culture report for the specimen collected 7/19/2007 was not provided.Operative records dated 9/11/2008 state the patient underwent exploratory laparotomy, lysis of adhesions and repair of incisional hernia, right upper quadrant, implantation of permacol mesh.The patient ¿is a 41-year-old female.She has had multiple abdominal surgeries.She is noted to be having pain in the right upper quadrant region and a suspected palpable hernia in the office.¿ the operative records dated 9/11/2008 continue: ¿a midline incision was made from the xiphisternum down through the area just to the umbilicus.The subcutaneous tissue was dissected through using the bovie pencil and the fascia was identified.The linea alba was identified and cleaned off from the subcutaneous fat.An incision was then made with a 10-blade scalpel and the abdomen was entered without difficulty.There were very few adhesions over the area of the liver; however, there were moderate adhesions, which were thin and filmy in the right upper quadrant region to the abdominal wall.These were taken down using the metzenbaum scissors and with also blunt dissection.¿ the records dated 9/11/2008 state: ¿the inspection of the lateral abdominal wall all the way back to the area of the kidney did not reveal any hernias laterally ; however, at the area of the laparoscopic cholecystectomy incision, there was noted to be a weakness in the abdominal wall consistent with a small hernia.A 10 x 15 permacol mesh was selected and placed into the abdominal cavity.Then, 0 tycron sutures were used in all 4 corners and in the midline for a total of 6 sutures.Securing this to the abdominal wall, the spiral tacker was then used to further secure the mesh to the abdominal wall in between the sutures.¿ the operative records dated 9/11/2008 continue: ¿once the hernia repair was complete, the air was irrigated out and any bleeding was controlled with electrocautery.There was minimal blood loss for the entire procedure.The fascia was then closed using 0 interrupted tycron pop-off sutures and the skin was then closed using surgical staples.¿ the records confirm a permacol mesh (non-gore device) was implanted.There was no mention of the gore devices in the records and no mention of device removal.Operative/procedure records dated 10/22/2009 state the patient underwent an esophagogastroduodenoscopy procedure to rule out hiatal hernia versus esophagitis.Postoperative diagnosis: normal endoscopy.Records between 10/22/2009 and 4/12/2012 were not provided.Operative records dated 4/12/2012 state the patient underwent repair of incisional hernia, recurrent with mesh.The patient ¿is a 45-year-old female.She has a recurrent incisional hernia near the periumbilical region anteriorly.¿ the operative records dated 4/12/2012 state: ¿a midline incision was made.The subcutaneous tissues were dissected down until the fascia was encountered.There was some suture from previous hernia repair, this is removed.The abdomen was entered using a metzenbaum scissors and a bovie pencil.The fascia was opened up proximally and distally to the hernia defect.The hernia defect was then opened up and the sac was inspected.There was some minimal bowel in the sac.This is easily reducible back into the abdomen.¿ the operative records dated 4/12/2012 continue: ¿there were some omental and bowel adhesions to the undersurface of peritoneum from the previous hernia repair.These were taken down carefully using the metzenbaum scissors.Once there was a good circumferential area cleared away around the hernia defect, a physio mesh was selected.This was a 10 x 15 cm size mesh.This was inserted into the abdomen.It was then fixated on the undersurface of the peritoneum using 4 individual #0 tycron sutures in interrupted fashion in all 4 quadrants.¿ the records dated 4/12/2012 state: ¿the mesh was then tacked in place using the secure strap tacker.This was done circumferentially to prevent bowel encroachment anterior to the mesh.Once the hernia repair was completed, the area was irrigated out.The fascia was closed over the hernia defect using a 0 interrupted vicryl suture in a figure-of-eight fashion.The skin and subcutaneous tissues were then irrigated out and the skin was closed with surgical staples.¿ records indicate a ethicon physiomesh (non-gore device) was implanted.There was no mention of the gore devices in the records and no mention of device removal.Operative records dated 8/13/2013 state the patient underwent laparoscopic repair of recurrent incarcerated incisional hernia with mesh and removal of old mesh.The patient ¿is a 46-year-old female who has had 29 prior operations.She has had multiple laparotomies.Last year, she had repair of a midline hernia.She also has right upper quadrant incision with mesh in this area.She has now developed a recurrence in the upper portion of the midline incision.¿ the operative records dated 8/13/2013 state: ¿veress needle was inserted and pneumoperitoneum was created.The visiport was then used to enter the peritoneal cavity under direct vision.The left side of the abdomen as expected is clear and two 5-mm trocars were placed in the lower abdomen.The midline and upper abdomen are packed full of adhesions.These are slowly taken down from the anterior abdominal wall carefully.Where there was omentum to the abdominal wall, the harmonic scalpel was used.¿ the records dated 8/13/2013 state: ¿some of the adhesions are very filmy and these were taken down sharply.There was one area of adhesions that involves bowel and this was also taken down sharply.There are some adhesions of the stomach to the anterior abdominal wall and these were taken down using sharp dissection.At the conclusion of the procedure, the abdomen was carefully inspected and there was no evidence of bowel injury or leak or bleeding.As the adhesions were taken down, it can be seen that there was a piece of large bore soft mesh in the midline.¿ the operative records dated 8/13/2013 continue: ¿this mesh was not incorporated in the abdominal wall and there is quite a bit of omentum incarcerated through tears in the mesh between the mesh and the abdominal wall.It was later found that this is a piece of physiomesh.After tedious dissection, all of the adhesions are taken down off the abdominal wall.The physiomesh was in the midline.There is a piece of gore-tex mesh tacked in the right upper quadrant, which was very well incorporated.Once this physiomesh was exposed, it was then removed using sharp dissection.Again, it is not incorporated all into the abdominal wall and is only necessary to cut the mesh around the periphery where it was sewn in place.¿ the records dated 8/13/2013 state: ¿the mesh was then removed from the abdominal cavity.It can now be seen that the defect is in the midline.There are multiple small defects and then a larger diastasis of the rectus muscles of approximately 4-5 inches.A piece of 8 x 10 inch sepramesh with the echo balloon delivery system was inserted in the peritoneal cavity.This was pulled up against the abdominal wall.The mesh extends from the pubic bone all the way up to the liver edge, which is adherent to the abdominal wall does cover the defect with a good 1-2 inches of overlap.The mesh has positioned well.It was then tacked in place.There are spots where the new mesh overlies the old gore-tex mesh.¿ operative records dated 8/13/2013 continue: ¿a protack titanium tack was used in this location.The remainder of the mesh was tacked in place using a strap tacker.The balloon was removed from the mesh.The mesh was then also secured with transfascial sutures of 0 ethibond spaced above, at the superior and inferior aspect of the mesh.An additional 5 mm trocar was placed in the right abdomen for tacking.The 12 mm trocar site was closed with 0 vicryl.Pneumoperitoneum released and the skin incisions are closed with 4-0 monocryl.Steri-strips and sterile dressings are applied.¿ records confirm a ventralight st mesh was implanted.Pathology report dated 8/13/2013 states: ¿the specimen consists of a tan to pink irregular synthetic 1 0.4 x 8.0 x 0.2 cm material consistent with mesh.There is a yellow lobulated to white pliable, stringy soft tissue attached.The specimen is sectioned and representative sections are submitted in one cassette.Diagnosis: specimen submitted as "old mesh": fibrofatty tissue containing mesh surrounded by foreign body giant cell reaction and focal minimal chronic inflammation.¿ procedure records dated 2/14/2014 state the patient underwent left cardiac catheterization, coronary angiography and left ventriculogram for treatment of unstable angina.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® 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.¿ 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.
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Manufacturer Narrative
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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: 03/18/06: bronson battle creek.Matthew s.Pilsbury, md.Emergency room visit.Cc: painful bulge above incision from hernia repair 2 weeks ago.Bulge noted x 2 days.03/20/06: bronson battle creek.James b.Nolin, md.Emergency room visit.Hpi: presents with wound infection.Age of the wound is 4 days.Location rlq abdomen.Wound etiology surgery hernia repair 2 ½ weeks ago.Drainage moderate (yellow-green).Exam: moderate distress.Abdominal: tenderness: severe right upper quadrant, right lower quadrant.Description of wound: appears infected (erythema right mid abd wound, no drainage), very tender in area of wound and several cm above and below.Wbc 17.3.Impression/plan: abdominal surgical wound infection.Admit.03/20/06: bronson battle creek.William f.Coughlin, md.Radiology ¿ ct abdomen/pelvis with contrast.Indication: postop infection.Findings: lung bases are normal.There are no focal liver lesions.The gallbladder had been removed.The spleen is normal.The bowel is not dilated.The left kidney is normal.The right kidney is absent.In the pelvis, no masses or inflammatory change.The patient has a crescentic shaped fluid collection in the anterior abdominal wall superficial to the hernia repair.It measures 10 x 3 cm in greatest dimensions.Impression: crescentic shaped fluid collection over the right anterior abdominal wall.Hernia repair.No intra-abdominal abnormality seen.03/20/06: bronson battle creek.Forrest d.Robert, do.History and physical.Cc: right upper quadrant pain with swelling, status post hernia repair.Hpi: has developed erythema and pain in the right upper quadrant which has become locally tender and painful.Has a ct scan which reveals a fluid collection under the skin which possibly may be an abscess.Has had some fevers over the last couple of days and also has developed some leukocytosis of 17,000.Exam: abdomen: moderate swelling and tenderness in the right upper quadrant.Incision not draining at this time but slightly erythematous.No palpable mass noted.There is some fluid palpable under the skin.Impression: fluid collection in the right upper quadrant with abdominal pain and fever as well as leukocytosis, possible abscess.Plan: take to the operating room and do incision and drainage of this area.May need the mesh removed if there is purulent debris in the abdominal incision.Start on clindamycin 600 mg every 8 hours.03/20/06: bronson battle creek.Lab ¿ microbiology.Aerobic culture.Source: abscess; mesh from hernia repair.Accession #: 06-079-1312.Collected 03/20/06 @17:53.Gram stain report: few white blood cells; no organisms seen; amorphous material.Final report: culture yields no growth.Anaerobic culture: accession #: 06-079-1311.Gram stain report: rare white blood cells; no organisms seen; amorphous material.Final report: no anaerobes recovered.03/20/06: bronson battle creek.Lab ¿ microbiology.Aerobic culture.Source: abscess; mesh from surgical incision (hernia repair site, right abdominal wall).Accession #: 06-079-1390.Collected: 03/20/06 @18:48.Gram stain report: few white blood cells; no organisms seen; amorphous material.Final report: 1+ staphylococcus aureus recovered.Anaerobic culture: accession #: 06-079-1389.Gram stain report: few white blood cells; no organisms seen; amorphous material.Final report: no anaerobes recovered.03/20/06: bronson battle creek.Lab ¿ microbiology.Gram stain.Collected: 03/20/06 @17:53.Accession #: 06-079-1313.Source: mesh from hernia repair.Final report: few white blood cells; no organisms seen; amorphous material; smear reviewed by pathology department personnel no significant changes from stat result report.03/21/06: bronson battle creek.Forrest d.Robert, do.Discharge summary.Discharge dx: abscess, abdominal wall; infected prosthetic mesh, anterior abdominal wall; status post hernia repair; leukocytosis.Hospital course: developed and infection of the mesh and in the subcu and came in with leukocytosis and right upper quadrant abdominal pain.Had been treated with keflex as outpatient, but did not solve problem.Was taken to the operating room on 03/20/06.Had i&d of abscess as well as removal of the abdominal mesh.Gram stain was negative for any organisms, but there was a foul odor on the mesh, and it was decided to remove it.Had a jackson-pratt drain placed, and it appears that the hernia has not recurred.10/10/06: bronson battle creek.Forrest d.Robert, do.History and physical.Cc: hernia.Hpi: hx right upper quadrant abdominal pain.Had a hernia repair done by me in the area of previous open cholecystectomy incision.Now complaining of a new site of a hernia, which is in the right upper quadrant just under the rib cage.This is in the area of previous port site from previous laparoscopy.Has been painful and has noticed a bulge when coughs or sneezes.Exam: gastrointestinal: there is some bulging in the area of the right upper quadrant just under the right rib cage.Slightly tender to palpation.Impression: right upper quadrant incisional hernia from previously laparoscopic port site.Plan: elective outpatient right upper quadrant abdominal wall hernia repair at the area of previous incision.10/19/06: battle creek health system.Forrest d.Robert, do.Discharge instructions.Activity restrictions: lifting to 10 lbs.07/11/07: battle creek surgical, pc.Forrest d.Robert, do.Office notes.Cc: hernia.Hpi: onset gradual; abdominal pain began approximately 1 month ago.Exam: abdomen: a tender mass is noted in the right upper quadrant.Approximately 2 cm nonreducible.Impression: right upper quadrant possible mesh vs.Recurrent hernia.Plan: exploration ruq abdominal wall with possible mesh removal or hernia repair.04/05/12: bronson battle creek.Steven e.Miltz-miller, md.Radiology ¿ ct abdomen and pelvis without contrast.Indication: abdominal pain in the right lower quadrant.Findings: post-surgical changes in the abdominal wall.Small bowel pattern appears normal.No inflammatory process, mass or adenopathy.Herniation of mid abdominal wall containing fat.Impression: absent right kidney or nephrectomy.Post-surgical changes.Small midline abdominal hernia.06/11/13: bronson battle creek.Indraneel n.Banerji, md.Radiology ¿ ct abdomen and pelvis without contrast.Indication: right and low abdominal pain status post colonoscopy and endoscopy yesterday.Impression: no acute process in the abdomen or pelvis.No evidence of perforation.08/29/13: bronson battle creek.Indraneel n.Banerji, md.Radiology ¿ ct abdomen/pelvis with contrast.Indication: right lower quadrant pain and pelvic pain for 3 days.Mesh removed in august of 2013.Impression: minimally thickened cecum with small amount of adjacent fat stranding may indicate inflammatory, infectious or less likely neoplastic process with microperforation 08/29/13: bronson battle creek.Reza m.Tehrani, md.History and physical.Hpi: recent surgery for mesh placement for a hernia, had ct of the abdomen done, which shows inflammation or possibly microperfusion [sic].Has been admitted for the same.Impression: post laparoscopic repair of recurrent incarcerated incisional hernia with mesh and removal of old mass [sic, mesh] on 08/13/13.Cecal inflammation and possible microperforation.Plan: iv hydration, iv antibiotics and surgical consultation.08/31/13: bronson battle creek.Steven e.Miltz-miller, md.Radiology ¿ ct abdomen/pelvis with contrast.Indication: abdominal pain and pelvic pain.Concern for cecal perforation.Impression: small bilateral pleural effusions and minimal bibasilar atelectasis.Otherwise negative study.09/01/13: bronson battle creek.Reza m.Tehrani, md.Discharge summary.Hospital course: admitted with abdominal pain.Had a ct of abdomen showed inflammation or possibly microperforation.Was started on antibiotics, showed significant improvement with antibiotic therapy.Final dx: abdominal pain, colon inflammation and question of microperforation on first cat scan, the second cat scan did not show any pathology.Recent surgery for laparoscopic repair of recurrent incarcerated incisional hernia with mesh removal on 08/13/13 prior to this hospitalization.09/27/13: bronson battle creek.James h.Timmons, md.Radiology ¿ ct abdomen/pelvis with contrast.Indication: epigastric and right lower quadrant pain.Recent umbilical hernia repair.Impression: no abnormality in the current study.Previous effusions and periumbilical seroma have resolved.Small amount of ascites visible on the previous study has also resolved.06/13/14: bronson battle creek.Jessica a.Wright, do.Emergency room visit.Cc: abdominal pain x 3 days.Hpi: chronic ruq abd pain since 1996.Ed course: notes chronic ruq pain out of pain meds.Scheduled for f/u with general surgeon monday.No evidence of bowel obstruction improved pain on f/u exam.Smiling, laughing and walking around without pain prior to discharge.Impression: chronic ruq abdominal pain.Plan: discharge.09/24/14: bronson battle creek.James e.Dartt, md.Emergency room visit.Cc: abdominal pain; diarrhea.Hpi: mid abdominal pain with diarrhea x 3 days no vomiting.Impression: abdominal pain.Plan: discharge.09/24/14: bronson battle creek.Stephane l.Delaunay, md.Radiology ¿ ct abdomen/pelvis without contrast.Indication: pain without trauma.Impression: no acute process identified.10/24/14: bronson battle creek.Brandon e.Plante, do.Emergency room visit.Cc: abdominal pain.Ed course: labs negative.Has had multiple ct scans of the abd last was 3 weeks ago.Has chronic stomach pain.Impression: upper abdominal pain.Plan: discharge.Reports being seen at u of m for mesh removal and was told that adhesions from mesh cause this type of pain.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® 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.¿ 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.
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Manufacturer Narrative
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No further investigation is required at this time.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.This event will be closed as no problem detected.Previous patient codes (2240, 1994, 3191: no term/code available used for ¿mesh failure¿) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Medical records: the known medical records span (b)(6) 1999 through october 24, 2014 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Patient information: medical history: chronic pyelonephritis, smoker, on (b)(6) 2003: smokes ½ pack/day x20 years, spontaneous pneumothorax, (b)(6) 2004: small hiatal hernia, prior surgical procedures: 1990: right nephrectomy on (b)(6) 1992: cholecystectomy and placement of ruq [right upper quadrant] mesh on (b)(6) 1992: removal of mesh and replacement with new mesh at site of prior repair on (b)(6) 1993: sphincteroplasty, pancreas surgery [unknown date], appendectomy [unknown date].Relevant medical information: records prior to (b)(6) 1999, including records for any prior abdominal procedures, were not provided.Implant #1 preoperative complaints: on (b)(6) 1999: ¿this 32 year old female presents with evidence of reducible swelling in the right upper quadrant of the abdomen and on the examination, evidence of a reducible incisional hernia.The patient has had two prior right upper quadrant abdominal surgical incisions at the site of cholecystectomy and sphincteroplasty.She has also undergone a right nephrectomy and the herniation appears to be present near the confluence of these two areas.The patient has had nothing to suggest nausea, vomiting, obstipation, distention or suggestion of incarceration or strangulation.¿ ¿the patient has had marked difficulty with a prior repair of an incisional hernia in the right upper quadrant at the site of placement of the mesh.The mesh was removed and the wound was reconstructed several times.¿ implant #1 procedure: ventral incisional herniorrhaphy employing ¿gortex duofilm mesh¿ implant: gore® dualmesh® plus biomaterial (p14989-005/1dlmcp03) 10 cm x 15 cm, oval.Implant #1 date: (b)(6) 1999 [hospitalization dates unknown]: description of hernia being treated: ¿¿an oblique incision was made in the axis of the lateral portion of the right subcostal scar.This was carried into the confluence of the right subcostal scar with the right flank scar.The external and inferior oblique muscles were elevated at this time.The peritoneum was then reflected off the musculature and off the rectus muscle more medially.¿ implant size and fixation: ¿upon completion of this then the gortex duofilm, 10 by 15 cm, mesh with the proper orientation was placed into the defect.This was sutured about the margins of the defect beneath the muscle employing a running 0 prolene.Portions of the gortex were trimmed to fit the size of the defect itself.Upon completion of this then the area appeared to be adequately stabilized in the defect.The muscle and fascia were closed over the duofilm mesh employing interrupted 0 ethibond near-and-far sutures.The subcutaneous fat was almost nonexistent and the skin was closed with a running 3-0subcuticular absorbable suture.¿ no post-operative records were provided.Implant #2 preoperative complaints: on (b)(6) 2001: ¿this 34-year-old female had in november of 1999 undergone a repair of a ventral incisional hernia at the confluence of a cholecystectomy and right nephrectomv wound.The patient had had dual-mesh placed.The patient had demonstrated relief of symptoms following the repair and had done well until approximately several weeks prior at which time she noted the onset of a reducible swelling in the area of the previous repair.The patient states that she had been involved in significant lifting and straining.She noted significant local pain and tenderness.The patient, on examination, was found to have a bulge and significant weakness in the same area.¿ implant #2 procedure: repair of recurrent ventral incisional hernia; ¿gore-tex mesh¿ implant: gore® dualmesh® plus biomaterial with gore corduroy surface (00561995/1dlmcp03) 10cm x 15cm, oval.Implant #2 date: (b)(6) 2001 [hospitalization dates unknown] description of hernia being treated: ¿¿an incision was made in the right subcostal plane and then carried laterally along the old nephrectomy wound.With this then, the upper flap was reflected to the chest wall superiorly and inferiorly along the abdominal wall and along the area of the right flank.Following completion of this then, the muscle which was markedly attenuated was then incised.This raised a flap superiorly which was myofascial.The fascia was very weak and some of the peritoneal area was bulging through.¿ implant size and fixation: ¿following completion of this then, the gore-tex dual-film with the proper orientation was placed into the incision and sutured in place employing #1prolene mattress sutures.Kefzol solution was irrigated over the gore-tex graft and the gore-tex had been previously soaked in the 2% kefzol solution.Following completion of this then, the myofascial layer was closed over the gore-tex employing 0ethibond suture.Following completion of this then, the skin was closed with interrupted 3-0 silk deep vertical mattress sutures.¿ no post-operative records were provided.The previously placed gore® dualmesh® plus biomaterials are not mentioned in the (b)(6) 2001 operative record.Relevant medical information: on (b)(6) 2002: appendectomy.No reference is made to the either previously placed gore® dualmesh® plus biomaterial devices in the (b)(6) 2002 record.On (b)(6) 2003: laparoscopy, drainage of paratubal cysts, lysis of adhesions and right partial salpingectomy.¿the abdomen was filled with co2 with normal filling pressures.The upper abdomen was visualized.The liver surface appeared normal.There were some adhesions long the ligament of treitz but these were minor.The remainder of the upper abdomen essentially appeared to be normal.¿ no reference is made to the either previously placed gore® dualmesh® plus biomaterial devices in the (b)(6) 2003 record.On (b)(6) 2003: excision of appendiceal stump and total abdominal hysterectomy with bilateral oopho-salpingectomy.No reference is made to the either previously placed gore® dualmesh® plus biomaterial devices in the (b)(6) 2003 record.On (b)(6) 2004: esophagogastroduodenoscopic examination with biopsies of the duodenum, gastric antrum and gastroesophageal junction.Post-operative diagnosis: small superficial duodenal ulceration healing, antral gastritis, mild peptic esophagitis, small hiatal hernia.On (b)(6) 2006: incisional hernia repair with mesh placement.¿an incision was made along the previous nephrectomy line and the subcutaneous tissue was dissected down.There was a previous hernia repair with a mesh placement in this region.There was recurrence at the junction of the cholecystectomy incision and the nephrectomy incision.It was decided to repair this with an onlay mesh.A 4-x 6-inch piece of mesh was selected and the size was used to judge the clearing of the fascia.The fascia was cleared for a similar area around the hernia defect.Hernia defect itself was about 2 cm in size.The mesh was sewn anteriorly on the abdominal wall using 0interrupted surgidac sutures.This was done in a circumferential fashion.There were no gaps noted in the mesh.The mesh was then irrigated and the subcutaneum was closed using a 3-0 vicryl suture.Skin was then closed using surgical staples.¿ records indicate a non-gore device was implanted during the (b)(6) 2006 procedure.No reference is made to the either previously placed gore® dualmesh® plus biomaterial devices in the (b)(6) 2006 record.On (b)(6) 2006: emergency room: ¿painful bulge above incision from hernia repair 2 weeks ago.Bulge noted x 2 days.¿ on (b)(6) 2006: emergency room: ¿hpi: presents with wound infection.Age of the wound is 4 days.Location rlq abdomen.Wound etiology surgery hernia repair 2 ½ weeks ago.Drainage moderate (yellow-green).¿ on (b)(6) 2006: ct abdomen/pelvis: ¿crescentic shaped fluid collection over the right anterior abdominal wall.Hernia repair.No intra-abdominal abnormality seen.¿ on (b)(6) 2006: history and physical: ¿fluid collection in the right upper quadrant with abdominal pain and fever as well as leukocytosis, possible abscess.Plan: take to the operating room and do incision and drainage of this area.May need the mesh removed if there is purulent debris in the abdominal incision.¿ on (b)(6) 2006: incision and drainage of abdominal wall abscess and removal of infected mesh in the abdominal wall ¿an incision was made with the 10 blade scalpel over the previous incision.The subcutaneous tissues were immediately entered and a large purulent debris was expressed.Cultures were sent for gram stain as well as culture and sensitivity.Because of the malodorous emission from the wound, it was thought that the wound was certainly infected and that the mesh should be removed.There was some filmy bile and exudated material along the mesh.This was removed along with the entire mesh.The mesh was cut off from the abdominal wall and came out from the abdominal fascia fairly readily.There was a small resulting hernia defect and this was suture closed using 0vicryl suture.The area was then fairly irrigated out and any remaining surgidac suture was removed from the mesh and from the abdominal wall.The mesh was sent for culture as well.The wound was then closed by inserting a blake drain through a separate stab incision, and the skin was closed in a single layer using surgical staples.The drain was connected to suction.Prior to closure, the wound was thoroughly irrigated out using approximately a liter of normal saline which was sterile.¿ no reference is made to the either previously placed gore® dualmesh® plus biomaterial devices in the (b)(6) 2006 record.On (b)(6) 2006: microbiology: ¿source: abscess; mesh from hernia repair.¿ ¿culture yields no growth.¿ on (b)(6) 2006: microbiology: ¿source: abscess; mesh from surgical incision (hernia repair site, right abdominal wall).¿ ¿1+ staphylococcus aureus recovered.¿ on (b)(6) 2006: discharge summary: ¿developed and infection of the mesh and in the subcu [subcutaneous tissue] and came in with leukocytosis and right upper quadrant abdominal pain.Had been treated with keflex as outpatient, but did not solve problem.Was taken to the operating room on (b)(6) 2006.Had i&d of abscess as well as removal of the abdominal mesh.Gram stain was negative for any organisms, but there was a foul odor on the mesh, and it was decided to remove it.Had a jackson-pratt drain placed, and it appears that the hernia has not recurred.¿ on (b)(6) 2006: history and physical: ¿had a hernia repair done by me in the area of previous open cholecystectomy incision.Now complaining of a new site of a hernia, which is in the right upper quadrant just under the rib cage.This is in the area of previous port site from previous laparoscopy.Has been painful and has noticed a bulge when coughs or sneezes.¿ on (b)(6) 2006: incisional hernia repair.[the patient] ¿is a 39 -year-old female.She has a history of right upper quadrant abdominal pain and bulge.She has a history of multiple incisional hernias in the past and now has a new incisional hernia at the area of her laparoscopic port site from previous surgery.¿ ¿the right upper quadrant was palpated, and the area of hernia was identified.A transverse incision was made in a kocher style fashion until the subcutaneous tissues were identified.There was a small hernia which was approximately 1.5 cm in total size with a small hernia sac.This was imbricated primarily and closed using o interrupted surgidac sutures with good healthy fascia on either side.This was really close to the edge of the rib, so some of the fascia over the ribcage was brought down for closure.¿ no references is made to the either previously placed gore® dualmesh® plus biomaterial devices in the 10/19/2006 record.On (b)(6) 2007: excision of suture granuloma of the anterior abdominal wall.¿a right upper quadrant incision was made using a 10-blade scalpel.The subcutaneous tissues was [sic] dissected down until the palpable mass was encountered.It was carefully entered and there was purulent debris inside.It was cultured although i believe this was most likely secondary to sterile pyogenic granuloma as there was noted to be suture material at the base of the abscess cavity.The suture was completely removed and it appeared to be braided 0 ¿tycrons [sic].The area around the capsule was excised using the bovie pencil and sent to pathology.The remaining area was then irrigated out.Fascia was not violated during the procedure.The subcutaneous was closed using a 3-0 running vicryl suture.¿ on (b)(6) 2007: pathology: ¿suture granuloma, negative for neoplasia.¿ a culture report for the specimen collected (b)(6) 2007 was not provided.On (b)(6) 2008: exploratory laparotomy, lysis of adhesions and repair of incisional hernia, right upper quadrant, implantation of permacol mesh.[the patient] ¿is a 41-year-old female.She has had multiple abdominal surgeries.She is noted to be having pain in the right upper quadrant region and a suspected palpable hernia in the office.¿ ¿¿a midline incision was made from the xiphisternum down through the area just to the umbilicus.The subcutaneous tissue was dissected through using the bovie pencil and the fascia was identified.The linea alba was identified and cleaned off from the subcutaneous fat.An incision was then made with a 10-blade scalpel and the abdomen was entered without difficulty.There were very few adhesions over the area of the liver; however, there were moderate adhesions, which were thin and filmy in the right upper quadrant region to the abdominal wall.These were taken down using the metzenbaum scissors and with also blunt dissection.The inspection of the lateral abdominal wall all the way back to the area of the kidney did not reveal any hernias laterally; however, at the area of the laparoscopic cholecystectomy incision, there was noted to be a weakness in the abdominal wall consistent with a small hernia.A 10 x 15 permacol mesh was selected and placed into the abdominal cavity.Then, 0 tycron sutures [sic] were used in all 4 corners and in the midline for a total of 6 sutures.Securing this to the abdominal wall, the spiral tacker was then used to further secure the mesh to the abdominal wall in between the sutures.Once the hernia repair was complete, the air was irrigated out and any bleeding was controlled with electrocautery.There was minimal blood loss for the entire procedure.The fascia was then closed using 0 interrupted tycron [sic] pop-off sutures and the skin was then closed using surgical staples.¿ records indicate a non-gore device was implanted during the (b)(6) 2008 procedure.No reference is made to the either previously placed gore® dualmesh® plus biomaterial devices in the (b)(6) 2008 record.On (b)(6) 2009: esophagogastroduodenoscopy [rule out hiatal hernia vs.Esophagitis].Post-operative diagnosis: ¿normal endoscopy.¿ on (b)(6) 2012: ct abdomen/pelvis: ¿absent right kidney or nephrectomy.Post-surgical changes.Small midline abdominal hernia.¿ on (b)(6) 2012: repair of incisional hernia, recurrent with mesh.¿a midline incision was made.The subcutaneous tissues were dissected down until the fascia was encountered.There was some suture from previous hernia repair, this is removed.The abdomen was entered using a metzenbaum scissors and a bovie pencil.The fascia was opened up proximally and distally to the hernia defect.The hernia defect was then opened up and the sac was inspected.There was some minimal bowel in the sac.This is easily reducible back into the abdomen.There were some omental and bowel adhesions to the undersurface of peritoneum from the previous hernia repair.These were taken down carefully using the metzenbaum scissors.Once there was a good circumferential area cleared away around the hernia defect, a physio mesh was selected.This was a 10 x 15 cm size mesh.This was inserted into the abdomen.It was then fixated on the undersurface of the peritoneum using 4 individual #0 tycron [sic] sutures in interrupted fashion in all 4 quadrants.The mesh was then tacked in place using the secure strap tacker.This was done circumferentially to prevent bowel encroachment anterior to the mesh.Once the hernia repair was completed, the area was irrigated out.The fascia was closed over the hernia defect using a 0 interrupted vicryl suture in a figure-of-eight fashion.¿ records indicate that a non-gore device was implanted during the (b)(6) 2012 procedure.No reference is made to the either previously placed gore® dualmesh® plus biomaterial devices in the (b)(6) 2012 record.On (b)(6) 2013: ct abdomen/pelvis: ¿indication: right and low abdominal pain status post colonoscopy and endoscopy yesterday.Impression: no acute process in the abdomen or pelvis.No evidence of perforation.¿ on (b)(6) 2013: laparoscopic repair of recurrent incarcerated incisional hernia with mesh and removal of old mesh [the patient] ¿is a 46-year-old female who has had 29 prior operations.She has had multiple laparotomies.Last year, she had repair of a midline hernia.She also has right upper quadrant incision with mesh in this area.She has now developed a recurrence in the upper portion of the midline incision.¿ ¿veress needle was inserted and pneumoperitoneum was created.The visiport was then used to enter the peritoneal cavity under direct vision.The left side of the abdomen as expected is clear and two 5-mm trocars were placed in the lower abdomen.The midline and upper abdomen are packed full of adhesions.These are slowly taken down from the anterior abdominal wall carefully.Where there was omentum to the abdominal wall, the harmonic scalpel was used.Some of the adhesions are very filmy and these were taken down sharply.There was one area of adhesions that involves bowel and this was also taken down sharply.There are some adhesions of the stomach to the anterior abdominal wall and these were taken down using sharp dissection.At the conclusion of the procedure, the abdomen was carefully inspected and there was no evidence of bowel injury or leak or bleeding.As the adhesions were taken down, it can be seen that there was a piece of large bore soft mesh in the midline.This mesh was not incorporated in the abdominal wall and there is quite a bit of omentum incarcerated through tears in the mesh between the mesh and the abdominal wall.It was later found that this is a piece of physiomesh.After tedious dissection, all of the adhesions are taken down off the abdominal wall.The physiomesh was in the midline.There is a piece of gore-tex mesh tacked in the right upper quadrant, which was very well incorporated.Once this physiomesh was exposed, it was then removed using sharp dissection.Again, it is not incorporated all into the abdominal wall and is only necessary to cut the mesh around the periphery where it was sewn in place.The mesh was then removed from the abdominal cavity.It can now be seen that the defect is in the midline.There are multiple small defects and then a larger diastasis of the rectus muscles of approximately 4-5 inches.Apiece [sic] of 8 x 10 inch sepramesh with the echo balloon delivery system was inserted in the peritoneal cavity.This was pulled up against the abdominal wall.The mesh extends from the pubic bone all the way up to the liver edge, which is adherent to the abdominal wall does cover the defect with a good 1-2 inches of overlap.The mesh has positioned well.It was then tacked in place.There are spots where the new mesh overlies the old gore-tex mesh.A protack titanium tack was used in this location.The remainder of the mesh was tacked in place using a strap tacker.The balloon was removed from the mesh.The mesh was then also secured with transfascial sutures of 0 ethibond spaced above, at the superior and inferior aspect of the mesh.An additional 5 mm trocar was placed in the right abdomen for tacking.The 12 mm trocar site was closed with 0 vicryl.Pneumoperitoneum released and the skin incisions are closed with 4-0 monocryl.¿ records indicate that a non-gore device was implanted during the (b)(6) 2013 procedure.On (b)(6) 2013: pathology: ¿the specimen consists of a tan to pink irregular synthetic 1 0.4 x 8.0 x 0.2 cm material consistent with mesh.There is a yellow lobulated to white pliable, stringy soft tissue attached.The specimen is sectioned and representative sections are submitted in one cassette.Diagnosis: specimen submitted as ¿old mesh¿: fibrofatty tissue containing mesh surrounded by foreign body giant cell reaction and focal minimal chronic inflammation.¿ on (b)(6) 2013: ct abdomen/pelvis: ¿right lower quadrant pain and pelvic pain for 3 days.Mesh removed in (b)(6) 2013.Impression: minimally thickened cecum with small amount of adjacent fat stranding may indicate inflammatory, infectious or less likely neoplastic process with microperforation.¿ on (b)(6) 2013: ct abdomen/pelvis: ¿small bilateral pleural effusions and minimal bibasilar atelectasis.Otherwise negative study.¿ on (b)(6) 2013: discharge summary: ¿admitted with abdominal pain.Had a ct of abdomen showed inflammation or possibly microperforation.Was started on antibiotics, showed significant improvement with antibiotic therapy.Final dx [diagnosis]: abdominal pain, colon inflammation and question of microperforation on first cat scan, the second cat scan did not show any pathology.Recent surgery for laparoscopic repair of recurrent incarcerated incisional hernia with mesh removal on (b)(6) 2013 prior to this hospitalization.¿ on (b)(6) 2013: ct abdomen/pelvis: ¿no abnormality in the current study.Previous effusions and periumbilical seroma have resolved.Small amount of ascites visible on the previous study has also resolved.¿ on (b)(6) 2014: emergency room: ¿chronic ruq abd pain since 1996.Ed course: notes chronic ruq pain out of pain meds.Scheduled for f/u with general surgeon monday.No evidence of bowel obstruction improved pain on f/u exam.Smiling, laughing and walking around without pain prior to discharge.¿ on (b)(6) 2014: ct abdomen/pelvis: ¿indication: pain without trauma.Impression: no acute process identified.¿ on (b)(6) 2014: emergency room: ¿has had multiple ct scans of the abd last was3 weeks ago.Has chronic stomach pain.Impression: upper abdominal pain.Plan: discharge.Reports being seen at u of m for mesh removal and was told that adhesions from mesh cause this type of pain.¿ conclusion: it should be noted that the gore® dualmesh® plus biomaterial instructions for use include 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 further state: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot 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 p14989-005.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.
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Search Alerts/Recalls
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