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

Device Problems Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Adhesion(s) (1695); Hernia (2240); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.(b)(6).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) 2015 whereby a gore® dualmesh® biomaterial was implanted.It was reported the patient alleges the following injuries: mesh re-sutured, mesh loosened, additional surgery, adhesions.Additional event specific information was not provided.

Event Description

Medical records indicate that on (b)(6) 2016, an additional procedure occurred whereby the gore device was explanted.

Manufacturer Narrative

B5: updated event description.B7: added medical history.D7: added explant date.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 prior to (b)(6) 2010, including records for exploratory laparoscopy (1997 and 2002), and cesarean section, with repair of infected cesarean section incision, were not provided.Medical records dated (b)(6) 2010 indicate patient was seen at hematology clinic in consultation for ¿chronic abdominal pain, skin rash.¿ the records state: ¿there has been a question of porphyria and she has tested positive for heterozygous mutation of the familial mediterranean fever gene.¿ ¿.Is a 30 year old woman who has had a skin rash for 4 years.¿history and physical dated 4/10/2015 states: ¿this 35-year-old woman comes with the complaint of having abdominal pain.She has had chronic abdominal pain recently in the last week.It has intensified to where she doubled over and had difficulty rising up.She came to the emergency room.A ct scan showed a cyst in her ovary as well as a large ventral hernia.She has a history in 2012 of having a cesarean section.She had an infection which required this to be drained.She has not had symptoms of incarceration of her bowel where she has had any blockage of gas or stool.She has had pain in the lower and right side of her abdomen.She has noticed a bulge in this area.¿ operative records dated (b)(6) 2015 indicate the patient underwent ¿laparoscopic ventral hernia repair.¿ preoperative/postoperative diagnosis ¿ventral hernia.¿ the records state: ¿the previous incision in the umbilicus was reentered and a veress needle inserted.After a drop test was performed, the abdomen was distended with carbon dioxide.After adequate insufflation, a 5 mm trocar was placed using the optview system.There were omental adhesions to the lower midline hernia.Two 5 mm ports were placed lateral to the umbilicus and the omental dissections were cut free allowing it to fall down.¿ operative records dated (b)(6) 2015 state: ¿this revealed a very large hernia of the midline from just below the umbilicus to the pubis.A sheet of dualmesh was then chosen.Sutures were placed circumferentially.It was then placed into the abdomen and using a small incision in an endo catch the sutures were then pulled through the fascia circumferentially suturing the mesh to the abdominal wall and closing the defect.A tacker was then used to cover this in spots in between the mesh.The carbon dioxide had been evacuated and the sutures tied prior to placement of tacks.The wounds were then closed with interrupted 3-0 vicryl in the trocar sites after evacuation and removal of the trocars and steri-strips were used to close the puncture sites where the sutures had been tied.¿ product identification records for the alleged gore dualmesh® biomaterial were not provided.Medical records dated (b)(6) 2015 state: ¿[patient] is a 35-year-old woman who comes following a laparoscopic ventral hernia repair.She states that initially she was doing exceptionally well and not having any problems.She went back to work last week driving.With driving this has caused soreness in her left side.She has not noticed any bulging but has had a marked amount of pain with this.Otherwise she continues to eat and have bowel movements without problems.She has not had any fever.On examination i cannot feel any evidence of a recurrent ventral hernia.Her incisions look good.¿ medical records dated (b)(6) 2015 state: ¿[patient] comes having been seen for continued pain on the lower right side of her abdomen.She had a ct scan which shows fluid above the mesh, as expected.There is no other apparent abnormality of this.She continues to have pain and discomfort.She initially had some pulling but she has not had any pain since then.On examination i cannot feel any defects.¿ ultrasound records dated (b)(6) 2015 indicate the patient underwent ¿ultrasound-guided subcutaneous seroma therapeutic aspiration.¿ the records state: ¿.Needle was inserted from an inferior approach into the subcutaneous fluid collection located just anterior to the abdominal wall mesh.Aspiration was performed obtaining a total of 115 ml of serosanguineous fluid that was discarded.¿ emergency department records dated (b)(6) 2015 state: ¿35-year-old female here today for evaluation of abdominal pain.The patient has a history of chronic and recurrent abdominal pain.She underwent a hernia repair earlier this year.She subsequently developed a seroma that was aspirated.She was following up with her pcp at that point and was having continued pain.Labs were drawn and she had a leukocytsis.She was treated with antibiotics.Her last office visit was june.¿ emergency department records dated (b)(6) 2015 state: ¿the patient said that over the course at today she started getting pain in her left lower quadrant.Her pain has been radiating into her back.She said that she also noticed some blood on the toilet tissue after wiping.She said that her pain is steady and cramping and stabbing in nature.Her pain is worse with standing up.¿ ¿impression: pyelonephritis.¿ emergency department records dated (b)(6) 2016 state: ¿.Presents to the ed with complaint of abdominal pain that worsened today.The patient reports that she saw her pcp., on 1/12 and had a ct-abdomen showing a 7 cm periumbilical hernia containing several bowel loops.She reports progressively worsening abdominal pain since then located to periumbilical area.The patient currently rates the abdominal pain as an 8 out of 10.She states that she has an appointment with the surgeon in 3 days, but she states that the pain is too severe to wait until then.The patient reports that she was prescribed hydrocodone for the pain but experienced associated nausea.She states that she was switched to tramadol but denies significant improvement of the pain.¿ history and physical dated (b)(6) 2016 states patient seen for chief complaint of ¿recurrent ventral hernia.¿ ¿the patient is a 36-year-old woman that i had seen last fall and performed a laparoscopic ventral hernia repair.She had a midline incision for a c-section.It became infected and had undergone a repair of this.She had done well from that time but did have a recurrence of fluid.She had continued to have some discomfort on this and the thought was that perhaps the fluid was accounting for this.¿ history and physical dated (b)(6) 2016 states: ¿she underwent an ultrasound-guided aspiration of 125 ml of fluid in (b)(6) 2015.She had not had any problems until recently when she had pain in her lower abdomen.She was seen at st elizabeth hospital and diagnosed with a recurrent hernia.There was concern that her white blood count was up and whether she had evidence of a graft infection.¿ ¿.A ct scan of this showed a ventral hernia just below the previous repair.The previous mesh was identified.It appears intact superiorly, but just in the lower aspect of her incision, it has a 7 cm opening with a large amount of small bowel protruding through this.The defect is 10cm below the umbilicus.¿ history and physical dated (b)(6) 2016 states: ¿the patient has not had fevers.She has not had redness around her incision.She has not had any drainage, but she has had pain and tenderness associated with this.Her white blood count has been mildly elevated to 14.1 with mild elevation of her sedimentation rate.¿ the record states: ¿physical examination abdomen: her abdomen is obese.She does have a palpable mass on the inferior aspect of her previous incision.There is not redness.There is no drainage.¿ history and physical dated (b)(6) /2016 states: ¿i have told them at this point she has a recurrent hernia.I am not certain as to whether this is due to infection, which is a possibility.I have told them that i am encouraged that i do not see nor did the radiologist see fluid around her hernia or along the mesh.She also has no external signs of infection of this, but i have told her that infection is a possibility that if this is the case that we would need to remove the mesh and do a primary repair with a component separation technique.¿ history and physical dated (b)(6) 2016 states: ¿this would be a larger operation with doing it open and extending her dissection quite laterally to release the muscles, i also discussed with her that it may be as simple as a stitch corning loose in the lower aspect of the mesh and that this has allowed intestines lo protrude out underneath this, or she may need another piece of mesh over this.I discussed with them and recommended they consider a repeat laparoscopic examination, that we look at the mesh and if the hernia is all below this, that we could conceivably repair this laparoscop1cally with another piece of mesh.I also discussed with her that it may mean a larger operation and it may require an open procedure even if there is not an infection.¿ medical records dated (b)(6) 2016 state: [patient] comes with her abdominal hernia.It is giving her a lot of pain and problems.She has a marked rash over her abdomen.There are some open sores.She is currently undergoing treatment.L have recommended that we continue the antibiotic that the dermatologist had placed her on.We will anticipate repairing this in a week's time.¿ operative records dated (b)(6) 2016 indicate the patient underwent ¿laparoscopic ventral hernia repair, resuturing a portion of the mesh.¿ preoperative/postoperative diagnosis ¿recurrent ventral hernia.¿ operative records dated (b)(6) 2016 state: ¿a small incision was made in the right upper quadrant and a 5-mm trocar was placed using the optiview system.The abdomen was then distended with carbon dioxide, the scope inserted.There were a large amount of adhesions present.I was able to see a clear spot in the left upper quadrant and a second 5-mm trocar was placed.The adhesions were then dissected down and i placed a right lower quadrant trocar, 5 mm, and freed up the adhesions of the abdomen.¿ operative records dated (b)(6) 2016 state: ¿there appeared to be a portion of the mesh that had pulled loose on the left lower side revealing a hernia sac.There was material in it that looked as gelled fluid.A catheter was placed in this.As i grasped this gel fluid it did rupture with blister-like fluid being present.This was suctioned and aspirated and sent for culture.The mesh was freed up from some adhesions.It was then resutured to the left lateral abdominal wall using interrupted prolene sutures.The edge was then tacked down with a tacking device.This covered the hernia without problems.The wounds were then closed with 4-0 vicryl in a subcuticular fashion.Sterile dressings were applied.¿ a culture report dated (b)(6) 2016 for a peritoneal fluid specimen obtained (b)(6) 2016 states: ¿culture body fluid aerobic-no growth at 5 days.Culture, anaerobic-no anaerobic growth after 5 days.¿ emergency department records dated (b)(6) 2016 indicate the patient was seen for chief complaint of ¿wound infection.¿ the records state ¿she states she has a wound under her pannus which drained pus.She also noticed increased redness around the area.The patient recently had laparoscopic ventral hernia repair.She stales the area that is draining is not one of the surgical sites.She states she has pain to the area which is 7/10.She denies nausea, vomiting and abdominal pain.¿ emergency department records dated (b)(6) 2016 state: ¿skin rash - treated for folliculitis for 2 years without improvement; dermatologist biopsied rash-superficicial epidermal necrosis, mild follicular inflammation, spongiosis and marked papillary edema-no evidence of porphyria, lichen planus or fungal infection.¿ emergency department records dated (b)(6) 2016 state: ¿a small midline abdominal wound underneath the patient's pannus is present.This is not at the surgical site per the patient.It was not actively draining at the time i evaluated the patient.A small amount of surrounding sialitis was present.A yeast infection was also present.The patient does have psoriasis which is present on the abdomen.¿ emergency department records dated (b)(6) 2016 state: ¿i feel the patient may have had a small subcutaneous abscess which ruptured and spontaneously drained.Surrounding cellulitis is present.No fluctuance or area to drain is present at the area of the wound.A surrounding used [sic] infection is present.The records also state ¿no evidence for postsurgical abscess or deep abdominal infection was present during the time of my evaluation.¿ a culture report dated (b)(6) 2016 states¿ culture: moderate growth escherichia coli, moderate growth mixed skin flora.¿ medical records dated (b)(6) 2016 state: ¿[patient] comes following a ventral hernia repair.She had a small incision made in the previous cesarean section at the bottom of her scar.She complains it was draining.She has a marked area of a fungal infection over her skin.She was placed on antibiotics in the emergency room as well as clomitrazole.I have recommended she continue with this and not use the triple antibiotic on her skin as "it is keeping this area moist where her pannus overlaps this.¿ medical records dated (b)(6) 2016 state: ¿[patient] wound looks much better after using the anti-fungal cream.It is not red.She has tenderness at the suture fixation points but otherwise is unremarkable.She complains of pain on the left side but i cannot feel any evidence of abnormality or other problems.¿ emergency department records dated (b)(6) 2016 indicate the patient was seen for chief complaint of ¿abdominal pain.¿ the record states: ¿the patient has had same "healing pain" since the surgery, but states that her pain became much worse over the past 3-4 days.The patient describes her pain as being "on the inside and outside" of her abdomen and locates it in a small area near the surgical site.The pain is worse with movement, especially when trying to sit up from a laying position.She rates her pain at a 7 or 8 out of 10 while in the ed.The patient denies fevers, nausea, vomiting, bloody stool or diarrhea.She mentions some intermittent burning with urination recently.¿ emergency department records dated (b)(6) 2016 state: ¿there is a horizontal surgical incision to the lower abdomen.There is tenderness in the left lower quadrant just superior to the wound.There is no drainage or erythema.The upper abdomen is non tender.¿ ¿ct abdomen pelvis - impression: 1.Ventral wall hernia in the lower pelvis without significant change compared to the prior ct.2.A peripherally enhancing area at the left ovary measuring 2.2 x 1.9 cm likely a corpus luteal cyst, new since the prior exam 3.No fluid in the abdomen or pelvis.¿ emergency department records dated (b)(6) 2016 indicate patient was seen for ¿abdominal pain.¿ the records state: ¿patient with lower abdominal pain worse over the last couple of days.No nausea vomiting.Some diarrhea.No black or bloody stools.She notes a history of ventral hernia repair x2 with the last one being in february.No vaginal bleeding or discharge.Denies urinary symptoms.No back pain.No fever or chills.Nothing in particular makes symptoms better or worse.¿ ct abdomen/pelvis dated (b)(6) 2016 states: ¿abdominal wall: ventral hernia mesh material is again identified.Inferiorly, below the umbilicus, the left aspect of the mesh is retracted to the midline and there is a recurrent lower abdominal wall hernia above the symphysis pubis with loops of small bowel protruding through the hernia defect into the patient¿s lower pannus.There is no evidence of bowel obstruction.The upper aspect of the urinary bladder is in close proximity to the lower aspect of the abdominal hernia defect as seen previously.¿ emergency department records dated (b)(6) 2016 indicate the patient was seen for chief complaint of ¿abdominal pain.¿ the records state: ¿i saw her 4 days ago for the same pain.She ran out of vicodin yesterday and the pain is persistent.¿ ¿ct 4 days ago did show recurrence of ventral hernia.She plans on seeing the surgeon tomorrow and is just looking for pain medication to get her through until then.¿ operative records dated (b)(6) 2016 indicate the patient underwent ¿ventral hernia repair with mesh, retrojects placement of prolene mesh, lysis of adhesions.¿ preoperative/postoperative diagnosis ¿recurrent ventral hernia.¿ the records state: ¿a young female who has had a c-section and developed a wound infection followed by a hernia.She had a ventral hernia repair, laparoscopic x2 that failed.I saw her in clinic and we did discuss risks and benefits of an open ventral hernia repair with mesh.We discussed the need for panniculectomy at the same time to optimize the outcome.¿ operative records dated (b)(6) 2016 state ¿plastic surgery began first and performed a panniculectomy.¿ the records state: ¿a 10-blade was used to incise the lower incision through the skin.This was dissected through subcutaneous tissue using bovie electrocautery until the abdominal wall was encountered laterally.Medially the planes were not very discrete due to the multiple surgeries and scar tissue present.Once, this was dissected as far medially as safe, a decision was then made to reflex the bed and double check the superior marks that were made in preoperative holding.¿ operative records dated (b)(6) 2016 state: ¿the previous marks looks like there would be no problems with closure.A decision was made to make a top incision too, as this would allow us to approach the hernia circumferentially.The top incision was then made with a 10-blade through the skin and dissected through subcutaneous tissue using bovie electrocautery.Started laterally and lifted the entire pan nus off the abdominal wall until we identified the hernia sac medially.¿ operative records dated (b)(6) 2016 state: ¿this was carefully dissected using bovie and hemostat to avoid entering the hernia sac.The abdominal wall was then taken off the hernia sac and the total weight was 4383 grams.Throughout the dissection, a few large subcutaneous veins were identified and these were controlled using 2-0 vicryl ties or 2-0 vicryl sutures.At this point, general surgery came in for their portion of the procedure.¿ operative records dated (b)(6) 2016 state: ¿plastic surgery began first and performed a panniculectomy.¿ ¿we were intraperitoneal.We removed the old gore-tex mesh, it really was not stuck to anything.There really were not many intra-abdominal adhesions.We did some lysis of adhesions but it was quite minimal.We got into the posterior rectus sheath and identified the posterior rectus fascia up towards the umbilicus.Dissected into that space.¿ operative records dated (b)(6) 2016 state: of course, below the umbilicus it was more just peritoneal layer.Got down to cooper's ligament at the pelvis, and then went up the other side, again exposing this posterior rectus/peritoneal layer.Now we were satisfied that we were all the way to the edge of the rectus sheath.I now proceeded with closing this layer together.This was done with a 0 pds running from either direction.Even though this was "peritoneum" it came together quite nicely.None of the stitches pulled through, it really came together quite well.¿ operative records dated (b)(6) 2016 state: ¿i felt comfortable this was a good barrier for the mesh that i could put in prolene mesh.I used a piece of 30 x 30 mesh that i had cut down to appropriate size of about 20 x 15.This was secured to cooper's ligament inferiorly.This was secured to the midline superiorly and then 1 on each side, right at the edge of the rectus.It was trimmed to size.A 19-french drain was placed.¿ operative records dated (b)(6) /2016 state: ¿now, we closed the anterior rectus fascia.This was done with o pds also.We were very careful to make sure we get anterior rectus fascia and not just hernia sac components.This came together quite nicely.I did run one other layer of o pds of just some of the hernia sac which actually seemed quite strong.Now we trimmed off remaining hernia sac and fat using a ligasure.This gave us a nice hernia repair.We ensured hemostasis.¿ operative records dated (b)(6) 2016 continue: ¿i now turned the case back over to plastic surgery for closure of the panniculectomy.¿ ¿we were called back in to the room and then lifted the abdominal flap up to the costal margins laterally and the xiphoid superiorly.The bed was reflexed.It was felt that it was an especially significant amount of abdominal skin and an additional amount totaling 725 grams was resected mostly laterally to control for the dog ear.¿ operative records dated (b)(6) 2016 continue: ¿at this time, aggressive irrigation was performed as well as a hemostasis of the entire wound.General surgery had previously placed a 19-french drain which was then sent out through the pubic skin anteriorly.I placed 2 additional 15-french drains, one on each flank.Then 2-0 vicryl was used through scarpa's fascia, then lnsorb was used for deep dermal suture and a 3-0 monocryl subcuticular.Dermabond was placed on the wound.¿ records confirm ethicon prolene mesh, (non-gore device) was implanted during the procedure.Operative records dated (b)(6) 2016 state: ¿of note, the umbilicus was included with the resected specimen.General surgery did close the umbilical defect.The decision was made to take the umbilicus due to her history of multiple recurrent hernias and concern that if her umbilicus did not survive, it could potentially be a portal of infection towards her mesh.¿ operative records dated (b)(6) 2016 indicate the patient underwent ¿1.Sharp debridement of abdominal flap, 50cm x 4cm, x7cm deep.2.Vacuum assisted closure device.¿ preoperative/postoperative diagnosis ¿1.Abdominal skin necrosis.2.Intra-abdominal infection.¿ operative records dated (b)(6) 2016 state: ¿[patient] underwent a panniculectomy with ventral hernia repair 2-1 /2 weeks ago.She had been discharged and subsequently developed increasing pain and change in drainage consistency.She was admitted to the hospital and found to have elevated white count and the drain fluid was growing enterococcus and mrsa.Her abdominal flaps have progressive areas of necrosis, which is due to a combination of infection as well as her positive cotinine test.She was taken to the operating room today for an l&d of her abdomen.¿ operative records dated (b)(6) 2016 state: ¿.The grossly necrotic tissue was outlined and this was incised with a 15 blade.It was noted that this was full-thickness abdominal centrally and this was debrided until bleeding tissue was obtained.2-0 nylon were placed in the wound laterally that was still intact due to the fact that the 3-0 monocryl subcuticular was now removed with the debridement.Once the intra-abdominal cavity was entered, it was noted there was a significant amount of very cloudy thick fluid.Her abdominal wall had hypergranulation tissue present.This was then copiously irrigated with 3 liters of pulse lavage.Due to the appearance, the decision was made to delay closure and to place a vacuum assisted closure device.Two black sponges were placed in the wound and the vac was set to 125 mm of continuous suction.¿ operative records dated (b)(6) 2016 indicate the patient underwent ¿1.Sharp debridement of abdominal flap, 50cm x 4cm, x7cm deep.2.Vacuum assisted closure device.¿ preoperative/postoperative diagnosis ¿1.Abdominal skin necrosis.2.Intra-abdominal infection.¿ the records state ¿she presents to the or today for scheduled reexploration of abdominal wound, debridement, irrigation and vac dressing change.¿ operative records dated (b)(6) 2016 state: ¿on exploring the abdomen it was evident that the abdominal flap had areas of fat necrosis and frank infection.These areas were debrided sharply using a 15 blade.Additional areas that required debridement included the lower abdominal wall as well as at the base of the wound on the abdominal wall proper.¿ operative records dated (b)(6) 2016 state: ¿debridement was performed to bleeding healthy-appearing edges.Hemostasis was achieved with bovie electrocautery as needed.Wound was then copiously irrigated with the power irrigated.Three liters of saline were used.Given the ongoing infection we encountered we elected to perform vac dressing change as opposed to close the abdomen.Therefore, a 45 x 3.5 x 3 cm black sponge was used to fill the abdominal wound cavity, and then the vac was hooked up to 125 mm hg intermittent suction.¿ operative records dated (b)(6) 2016 indicate the patient underwent ¿sharp debridement of abdominal skin, fat necrosis and application of vac assisted closure dressing.¿ preoperative/postoperative diagnosis ¿abdominal wound infection status post panniculectomy.¿ the records state: ¿.She ultimately elected to return to the operating room today for a repeat debridement and vac closure.¿ operative records dated (b)(6) 2016 state: ¿the lateral skin edges were debrided sharply with a 15 blade.Hemostasis was achieved with bovie electrocautery.A central area of fat necrosis and 1.5 cm of skin was then debrided sharply with a 15 blade as there was additional skin necrosis from last debridement.Hemostasis was achieved with bovie electrocautery.The wound was then copiously irrigated.¿ operative records dated (b)(6) 2016 state: ¿we then elected to close the lateral edges of the incision approximately 15 cm bilaterally.This was achieved in 3 layers, first with a 2-0 pds then with 2-0 monocryl of the deep dermis.Lastly, 3-0 nylon sutures were used to approximate the skin.These sutures were simple interrupted.At the end of our debridement a 6 x 11 central area of wound dehiscence remained, therefore we elected to apply a vac negative pressure dressing (just to close her dressing.) one black sponge was inserted into the wound, it measured 6 x 11 cm and the vac was hooked up to 125 mmhg suction.There were no leaks.¿ operative records dated (b)(6) 2016 indicate the patient underwent ¿sharp debridement of 12 x 5 cm abdominal wound washout and primary closure.¿ preoperative/postoperative diagnosis ¿abdominal wound infection status post panniculectomy and ventral hernia repair.¿ operative records dated (b)(6) 2016 state: ¿we then sharply debrided a 5 cm area on the superior abdominal wound edge.Debridement was with a 15 blade into the level of bright red bleeding.There was no frank evidence of infection.We therefore power irrigated with 3 liters of normal saline.The wound edges were all clean and bleeding.Hemostasis was then achieved with bovie electrocautery.We obtained a wound culture and then closed the remained 12 x 5 cm central abdominal wound in 3 layers.The 3-0 pds was used to approximate the fascia in a simple interrupted fashion.Then 3-0 monocryl was used to approximate the deep dermis.Then 3-0 nylons were used in simple interrupted fashion to approximate the skin.Sterile dressing was then applied.¿ operative records dated (b)(6) 2016 indicate the patient underwent ¿excisional debridement of abdominal wall including skin and subcutaneous fat, 17 x 2.5 cm, and abdominal wall closure with drain placement.¿ postoperative diagnosis ¿abdominal wall wound, 17 x 2.5 cm, status post panniculectomy and hernia repair, with abdominal wall seroma.¿ operative records dated (b)(6) 2016 state: ¿the patient is a 36-year-old female with a history of hernia repair by general surgery as well as panniculectomy by our service, complicated by a seroma and infection as well as wound healing problems, who presents with eschar at the abdominal incision which has declared itself and continues to be painful for the patient.Also, a ct scan did show a loculated seroma present which at the time of the scan was not drainable.¿ operative records dated (b)(6) 2016 state: ¿the patient's sutures were all removed and then the eschar was excised with a few millimeters of adjacent tissue.This was removed including the subcutaneous fat.Significant seroma was encountered and approximately 50 ml of clear yellow fluid was drained.The tissue was sent for specimen, and the fluid was cultured.There was some granulation tissue over the abdominal fascia, and this was debrided with a curet.¿ operative records dated (b)(6) 2016 state: ¿the skin edges and fat were found to be bleeding healthily, and the entire wound was irrigated.Hemostasis was achieved with bipolar cautery.A 15-french drain was brought out through the incision laterally and trimmed to fit the tunneling, which was approximately 8 cm to the right underneath the closed incision, and 5 cm to the left.The abdominal wall was then closed with 2-0 pds in the scarpa fascial layer, 3-0 monocryl in the deep dermis, and 2-0 nylon simple interrupted sutures in the skin.¿ 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: conclusion code remains unchanged.This claim was withdrawn on 4/10/20, and the alleged product complaint is no longer being pursued at this time.The investigation will be completed with the available information.Conclusion code remains unchanged until the investigation is complete.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: health effect impact code: f26: no health consequences or impact.H6: additional investigation conclusion code: d17: appropriate term/code not available for "withdrawn complaint.¿ previous patient codes (1695 and 3191 used for "mesh re-sutured" and "mesh loosened.") were reported based on the original complaint and are no longer applicable per gore¿s investigation.This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.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.Medical records: the known medical records span (b)(6) 2010 through (b)(6) 2016 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.Product identification records for the alleged gore dualmesh® biomaterial were not provided.Patient information: medical history: smoker ½ pack/day for 15 years.Obesity, bmi 45, diabetes, chronic abdominal pain, endometriosis, depression, anemia, history of herpes, history of skin rashes, 1978, 2002: endometriosis, 2008: pancreatitis, 2010: positive for heterozygous mutation of the familial mediterranean fever gene.Prior surgical procedures: 2008: sphincterotomy, 2011, 2012: cesarean sections.Relevant medical information: (b)(6) 2010: ¿she has had chronic abdominal pain recently in the last week.It has intensified to where she doubled over and had difficulty rising up.She came to the emergency room.A ct scan showed a cyst in her ovary as well as a large ventral hernia.She has a history in 2012 of having a cesarean section.She had an infection which required this to be drained.She has not had symptoms of incarceration of her bowel where she has had any blockage of gas or stool.She has had pain in the lower and right side of her abdomen.She has noticed a bulge in this area.¿ implant preoperative complaints: (b)(6) 2015: preoperative/postoperative diagnosis ¿ventral hernia.¿ implant procedure: laparoscopic ventral hernia repair.Implant: gore® dualmesh® biomaterial (unk/unk).Implant date: (b)(6) 2015.Description of hernia being treated: ¿the previous incision in the umbilicus was reentered and a veress needle inserted.After a drop test was performed, the abdomen was distended with carbon dioxide.After adequate insufflation, a 5 mm trocar was placed using the optview system.There were omental adhesions to the lower midline hernia.Two 5 mm ports were placed lateral to the umbilicus and the omental dissections were cut free allowing it to fall down.¿ ¿this revealed a very large hernia of the midline from just below the umbilicus to the pubis.¿ implant size and fixation: ¿a sheet of dualmesh was then chosen.Sutures were placed circumferentially.It was then placed into the abdomen and using a small incision in an endo catch the sutures were then pulled through the fascia circumferentially suturing the mesh to the abdominal wall and closing the defect.A tacker was then used to cover this in spots in between the mesh.The carbon dioxide had been evacuated and the sutures tied prior to placement of tacks.The wounds were then closed with interrupted 3-0 vicryl in the trocar sites after evacuation and removal of the trocars and steri-strips were used to close the puncture sites where the sutures had been tied.¿ product identification records for the alleged gore® dualmesh® biomaterial were not provided.No post-operative records were provided.Relevant medical information: (b)(6) 2015: ¿¿.Initially she was doing exceptionally well and not having any problems.She went back to work last week driving.With driving this has caused soreness in her left side.She has not noticed any bulging but has had a marked amount of pain with this.Otherwise, she continues to eat and have bowel movements without problems.She has not had any fever.On examination i cannot feel any evidence of a recurrent ventral hernia.Her incisions look good.¿ ¿ (b)(6) 2015: ¿she had a ct scan which shows fluid above the mesh, as expected.There is no other apparent abnormality of this.She continues to have pain and discomfort.She initially had some pulling but she has not had any pain since then.On examination i cannot feel any defects.¿ (b)(6) 2015: ¿ultrasound-guided subcutaneous seroma therapeutic aspiration.¿ ¿.Needle was inserted from an inferior approach into the subcutaneous fluid collection located just anterior to the abdominal wall mesh.Aspiration was performed obtaining a total of 115 ml of serosanguineous fluid that was discarded.¿ (b)(6) 2016: ¿.Presents to the ed with complaint of abdominal pain that worsened today.The patient reports that she saw her pcp on 1/12 and had a ct-abdomen showing a 7 cm periumbilical hernia containing several bowel loops.She reports progressively worsening abdominal pain since then located to periumbilical area.The patient currently rates the abdominal pain as an 8 out of 10.She states that she has an appointment with the surgeon in 3 days, but she states that the pain is too severe to wait until then.The patient reports that she was prescribed hydrocodone for the pain but experienced associated nausea.She states that she was switched to tramadol but denies significant improvement of the pain.¿ (b)(6) 2016: ¿the patient is a 36-year-old woman that i had seen last fall and performed a laparoscopic ventral hernia repair.She had a midline incision for a c-section.It became infected and had undergone a repair of this.She had done well from that time but did have a recurrence of fluid.She had continued to have some discomfort on this and the thought was that perhaps the fluid was accounting for this.¿ ¿she underwent an ultrasound-guided aspiration of 125 ml of fluid in june of 2015.She had not had any problems until recently when she had pain in her lower abdomen.She was seen at st.Elizabeth hospital and diagnosed with a recurrent hernia.There was concern that her white blood count was up and whether she had evidence of a graft infection.¿ ¿.A ct scan of this showed a ventral hernia just below the previous repair.The previous mesh was identified.It appears intact superiorly, but just in the lower aspect of her incision, it has a 7 cm opening with a large amount of small bowel protruding through this.The defect is 10cm below the umbilicus.¿ ¿the patient has not had fevers.She has not had redness around her incision.She has not had any drainage, but she has had pain and tenderness associated with this.Her white blood count has been mildly elevated to 14.1 with mild elevation of her sedimentation rate.¿ ¿her abdomen is obese.She does have a palpable mass on the inferior aspect of her previous incision.There is not redness.There is no drainage.¿ ¿i have told them at this point she has a recurrent hernia.I am not certain as to whether this is due to infection, which is a possibility.I have told them that i am encouraged that i do not see nor did the radiologist see fluid around her hernia or along the mesh.She also has no external signs of infection of this, but i have told her that infection is a possibility that if this is the case that we would need to remove the mesh and do a primary repair with a component separation technique.¿ ¿this would be a larger operation with doing it open and extending her dissection quite laterally to release the muscles, i also discussed with her that it may be as simple as a stitch coming loose in the lower aspect of the mesh and that this has allowed intestines to protrude out underneath this, or she may need another piece of mesh over this.I discussed with them and recommended they consider a repeat laparoscopic examination, that we look at the mesh and if the hernia is all below this, that we could conceivably repair this laparoscopically with another piece of mesh.I also discussed with her that it may mean a larger operation and it may require an open procedure even if there is not an infection.¿ (b)(6) 2016: ¿.Comes with her abdominal hernia.It is giving her a lot of pain and problems.She has a marked rash over her abdomen.There are some open sores.She is currently undergoing treatment.L have recommended that we continue the antibiotic that the dermatologist had placed her on.We will anticipate repairing this in a week's time.¿ (b)(6) 2016: ¿laparoscopic ventral hernia repair, resuturing a portion of the mesh.¿ ¿recurrent ventral hernia.¿ ¿a small incision was made in the right upper quadrant and a 5-mm trocar was placed using the optiview system.The abdomen was then distended with carbon dioxide, the scope inserted.There were a large amount of adhesions present.I was able to see a clear spot in the left upper quadrant and a second 5-mm trocar was placed.The adhesions were then dissected down and i placed a right lower quadrant trocar, 5 mm, and freed up the adhesions of the abdomen.¿ ¿there appeared to be a portion of the mesh that had pulled loose on the left lower side revealing a hernia sac.There was material in it that looked as gelled fluid.A catheter was placed in this.As i grasped this gel fluid it did rupture with blister-like fluid being present.This was suctioned and aspirated and sent for culture.The mesh was freed up from some adhesions.It was then resutured to the left lateral abdominal wall using interrupted prolene sutures.The edge was then tacked down with a tacking device.This covered the hernia without problems.The wounds were then closed with 4-0 vicryl in a subcuticular fashion.Sterile dressings were applied.¿ (b)(6) 2016: culture: ¿culture body fluid aerobic-no growth at 5 days.Culture, anaerobic-no anaerobic growth after 5 days.¿ ¿culture: moderate growth escherichia coli, moderate growth mixed skin flora.¿ (b)(6) 2016: emergency department: ¿she states she has a wound under her pannus which drained pus.She also noticed increased redness around the area.The patient recently had laparoscopic ventral hernia repair.She stales the area that is draining is not one of the surgical sites.She states she has pain to the area which is 7/10.She denies nausea, vomiting and abdominal pain.¿ ¿skin rash - treated for folliculitis for 2 years without improvement; dermatologist biopsied rash-superficial epidermal necrosis, mild follicular inflammation, spongiosis and marked papillary edema-no evidence of porphyria, lichen planus or fungal infection.¿ ¿a small midline abdominal wound underneath the patient's pannus is present.This is not at the surgical site per the patient.It was not actively draining at the time i evaluated the patient.A small amount of surrounding sialitis was present.A yeast infection was also present.The patient does have psoriasis which is present on the abdomen.¿ ¿i feel the patient may have had a small subcutaneous abscess which ruptured and spontaneously drained.Surrounding cellulitis is present.No fluctuance or area to drain is present at the area of the wound.A surrounding [sic] used [sic] infection is present." ¿no evidence for postsurgical abscess or deep abdominal infection was present during the time of my evaluation.¿ (b)(6) 2016: ¿[patient] comes following a ventral hernia repair.She had a small incision made in the previous cesarean section at the bottom of her scar.She complains it was draining.She has a marked area of a fungal infection over her skin.She was placed on antibiotics in the emergency room as well as clomitrazole.I have recommended she continue with this and not use the triple antibiotic on her skin as ¿it is keeping this area moist where her pannus overlaps this¿.¿ (b)(6) 2016: ¿[patient] wound looks much better after using the anti-fungal cream.It is not red.She has tenderness at the suture fixation points but otherwise is unremarkable.She complains of pain on the left side but i cannot feel any evidence of abnormality or other problems.¿ (b)(6) 2016: emergency department: ¿ct abdomen pelvis - impression: 1.Ventral wall hernia in the lower pelvis without significant change compared to the prior ct.2.A peripherally enhancing area at the left ovary measuring 2.2 x 1.9 cm likely a corpus luteal cyst, new since the prior exam 3.No fluid in the abdomen or pelvis.¿ (b)(6) 2016: ct abdomen/pelvis: ¿abdominal wall: ventral hernia mesh material is again identified.Inferiorly, below the umbilicus, the left aspect of the mesh is retracted to the midline and there is a recurrent lower abdominal wall hernia above the symphysis pubis with loops of small bowel protruding through the hernia defect into the patient¿s lower pannus.There is no evidence of bowel obstruction.The upper aspect of the urinary bladder is in close proximity to the lower aspect of the abdominal hernia defect as seen previously.¿ (b)(6) 2016: emergency department: ¿i saw her 4 days ago for the same pain.She ran out of vicodin yesterday and the pain is persistent.¿ ¿ct 4 days ago did show recurrence of ventral hernia.She plans on seeing the surgeon tomorrow and is just looking for pain medication to get her through until then.¿ explant preoperative complaints: (b)(6) 2016: ¿a young female who has had a c-section and developed a wound infection followed by a hernia.She had a ventral hernia repair, laparoscopic x2 that failed.I saw her in clinic and we did discuss risks and benefits of an open ventral hernia repair with mesh.We discussed the need for panniculectomy at the same time to optimize the outcome.¿ explant procedure: ¿ventral hernia repair with mesh, retrorectus placement of prolene mesh, lysis of adhesions.¿ explant date: (b)(6) 2016.¿plastic surgery began first and performed a panniculectomy.¿ ¿a 10-blade was used to incise the lower incision through the skin.This was dissected through subcutaneous tissue using bovie electrocautery until the abdominal wall was encountered laterally.Medially the planes were not very discrete due to the multiple surgeries and scar tissue present.Once, this was dissected as far medially as safe, a decision was then made to reflex the bed and double check the superior marks that were made in preoperative holding.¿ ¿the previous marks looks [sic] like there would be no problems with closure.A decision was made to make a top incision too, as this would allow us to approach the hernia circumferentially.The top incision was then made with a 10-blade through the skin and dissected through subcutaneous tissue using bovie electrocautery.Started laterally and lifted the entire pannus off the abdominal wall until we identified the hernia sac medially.¿ ¿this was carefully dissected using bovie and hemostat to avoid entering the hernia sac.The abdominal wall was then taken off the hernia sac and the total weight was 4383grams.Throughout the dissection, a few large subcutaneous veins were identified and these were controlled using 2-0 vicryl ties or 2-0 vicryl sutures.At this point, general surgery came in for their portion of the procedure.¿ ¿plastic surgery began first and performed a panniculectomy.¿ ¿we were intraperitoneal.We removed the old gore-tex mesh, it really was not stuck to anything.There really were not many intra-abdominal adhesions.We did some lysis of adhesions but it was quite minimal.We got into the posterior rectus sheath and identified the posterior rectus fascia up towards the umbilicus.Dissected into that space.¿ ¿of course, below the umbilicus it was more just peritoneal layer.Got down to cooper's ligament at the pelvis, and then went up the other side, again exposing this posterior rectus/peritoneal layer.Now we were satisfied that we were all the way to the edge of the rectus sheath.I now proceeded with closing this layer together.This was done with a 0 pds running from either direction.Even though this was "peritoneum" it came together quite nicely.None of the stitches pulled through, it really came together quite well.¿ ¿i felt comfortable this was a good barrier for the mesh that i could put in prolene mesh.I used a piece of 30 x 30 [cm] mesh that i had cut down to appropriate size of about 20 x 15 [cm].This was secured to cooper's ligament inferiorly.This was secured to the midline superiorly and then 1 on each side, right at the edge of the rectus.It was trimmed to size.A 19-french drain was placed.¿ ¿now, we closed the anterior rectus fascia.This was done with o pds also.We were very careful to make sure we get anterior rectus fascia and not just hernia sac components.This came together quite nicely.I did run one other layer of o pds of just some of the hernia sac which actually seemed quite strong.Now we trimmed off remaining hernia sac and fat using a ligasure.This gave us a nice hernia repair.We ensured hemostasis.¿ ¿i now turned the case back over to plastic surgery for closure of the panniculectomy.¿ ¿we were called back in to the room and then lifted the abdominal flap up to the costal margins laterally and the xiphoid superiorly.The bed was reflexed.It was felt that it was an especially significant amount of abdominal skin and an additional amount totaling 725 grams was resected mostly laterally to control for the dog ear.¿ ¿at this time, aggressive irrigation was performed as well as a hemostasis of the entire wound.General surgery had previously placed a 19-french drain which was then sent out through the pubic skin anteriorly.I placed 2 additional 15-french drains, one on each flank.Then 2-0 vicryl was used through scarpa's fascia, then lnsorb was used for deep dermal suture and a 3-0 monocryl subcuticular.Dermabond was placed on the wound.¿ ¿of note, the umbilicus was included with the resected specimen.General surgery did close the umbilical defect.The decision was made to take the umbilicus due to her history of multiple recurrent hernias and concern that if her umbilicus did not survive, it could potentially be a portal of infection towards her mesh.¿ records confirm ethicon prolene mesh, (non-gore device) was implanted during the procedure.Relevant medical information: ¿ (b)(6) 2016: ¿1.Sharp debridement of abdominal flap, 50cm x 4cm, x7cm deep.2.Vacuum assisted closure device.¿ ¿1.Abdominal skin necrosis.2.Intra-abdominal infection.¿ ¿[patient] underwent a panniculectomy with ventral hernia repair 2-1 /2 weeks ago.She had been discharged and subsequently developed increasing pain and change in drainage consistency.She was admitted to the hospital and found to have elevated white count and the drain fluid was growing enterococcus and mrsa.Her abdominal flaps have progressive areas of necrosis, which is due to a combination of infection as well as her positive cotinine test.She was taken to the operating room today for an i&d of her abdomen.¿ ¿.The grossly necrotic tissue was outlined and this was incised with a 15 blade.It was noted that this was full-thickness abdominal centrally and this was debrided until bleeding tissue was obtained.2-0 nylon were placed in the wound laterally that was still intact due to the fact that the 3-0 monocryl subcuticular was now removed with the debridement.Once the intra-abdominal cavity was entered , it was noted there was a significant amount of very cloudy thick fluid.Her abdominal wall had hypergranulation tissue present.This was then copiously irrigated with 3 liters of pulse lavage.Due to the appearance, the decision was made to delay closure and to place a vacuum assisted closure device.Two black sponges were placed in the wound and the vac was set to 125 mm of continuous suction.¿ (b)(6) 2016: ¿1.Sharp debridement of abdominal flap, 50cm x 4cm, x7cm deep.2.Vacuum assisted closure device.¿ (b)(6) 2016: ¿sharp debridement of abdominal skin, fat necrosis and application of vac assisted closure dressing.¿ (b)(6) 2016: ¿sharp debridement of 12 x 5 cm abdominal wound washout and primary closure.¿ (b)(6) 2016: ¿excisional debridement of abdominal wall including skin and subcutaneous fat, 17 x 2.5 cm, and abdominal wall closure with drain placement.¿ conclusion: it should be noted that the gore® dualmesh® 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 instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ the instructions for use further state: ¿use only nonabsorbable sutures, such as gore-tex® suture, with a non-cutting needle (such as taper or piercing point) of appropriate size to anchor the device.The use of absorbable sutures may lead to inadequate anchoring of gore® dualmesh® plus biomaterial to the host tissue and necessitate reoperation.For best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ 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.Medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.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 health effect- clinical code.H6: updated investigation findings.H6: updated investigation conclusions.H6: health effect impact code: f26: no health consequences or impact.H6: additional investigation conclusion code: d17: appropriate term/code not available for "withdrawn complaint¿.Previous patient codes (1695 and 3191 used for "mesh re-sutured" and "mesh loosened.") were reported based on the original complaint and are no longer applicable per gore¿s investigation.This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.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.Medical records: the known medical records span september 29, 2010 through december 5, 2016 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.Product identification records for the alleged gore dualmesh® biomaterial were not provided.Patient information: medical history: smoker ½ pack/day for 15 years obesity, bmi 45, diabetes, chronic abdominal pain, endometriosis, depression , anemia, history of herpes, history of skin rashes, 1978, 2002: endometriosis, 2008: pancreatitis, 2010: positive for heterozygous mutation of the familial mediterranean fever gene.Prior surgical procedures: 2008: sphincterotomy , 2011, 2012: cesarean sections.Relevant medical information: on (b)(6) 2010: ¿she has had chronic abdominal pain recently in the last week.It has intensified to where she doubled over and had difficulty rising up.She came to the emergency room.A ct scan showed a cyst in her ovary as well as a large ventral hernia.She has a history in 2012 of having a cesarean section.She had an infection which required this to be drained.She has not had symptoms of incarceration of her bowel where she has had any blockage of gas or stool.She has had pain in the lower and right side of her abdomen.She has noticed a bulge in this area.¿ implant preoperative complaints: on (b)(6) 2015: preoperative/postoperative diagnosis ¿ventral hernia.¿ implant procedure: laparoscopic ventral hernia repair.Implant: gore® dualmesh® biomaterial (unk/unk).Implant date: (b)(6), 2015 description of hernia being treated: ¿the previous incision in the umbilicus was reentered and a veress needle inserted.After a drop test was performed, the abdomen was distended with carbon dioxide.After adequate insufflation, a 5 mm trocar was placed using the optview system.There were omental adhesions to the lower midline hernia.Two 5 mm ports were placed lateral to the umbilicus and the omental dissections were cut free allowing it to fall down.¿ ¿this revealed a very large hernia of the midline from just below the umbilicus to the pubis.¿ implant size and fixation: ¿a sheet of dualmesh was then chosen.Sutures were placed circumferentially.It was then placed into the abdomen and using a small incision in an endo catch the sutures were then pulled through the fascia circumferentially suturing the mesh to the abdominal wall and closing the defect.A tacker was then used to cover this in spots in between the mesh.The carbon dioxide had been evacuated and the sutures tied prior to placement of tacks.The wounds were then closed with interrupted 3-0 vicryl in the trocar sites after evacuation and removal of the trocars and steri-strips were used to close the puncture sites where the sutures had been tied.¿ product identification records for the alleged gore® dualmesh® biomaterial were not provided.No post-operative records were provided.Relevant medical information: on (b)(6) 2015: "initially she was doing exceptionally well and not having any problems.She went back to work last week driving.With driving this has caused soreness in her left side.She has not noticed any bulging but has had a marked amount of pain with this.Otherwise, she continues to eat and have bowel movements without problems.She has not had any fever.On examination i cannot feel any evidence of a recurrent ventral hernia.Her incisions look good.¿ on (b)(6) 2015: ¿she had a ct scan which shows fluid above the mesh, as expected.There is no other apparent abnormality of this.She continues to have pain and discomfort.She initially had some pulling but she has not had any pain since then.On examination i cannot feel any defects.¿ on (b)(6) 2015: ¿ultrasound-guided subcutaneous seroma therapeutic aspiration.Needle was inserted from an inferior approach into the subcutaneous fluid collection located just anterior to the abdominal wall mesh.Aspiration was performed obtaining a total of 115 ml of serosanguineous fluid that was discarded.¿ on (b)(6) 2016: ¿presents to the ed with complaint of abdominal pain that worsened today.The patient reports that she saw her pcp on 1/12 and had a ct-abdomen showing a 7 cm periumbilical hernia containing several bowel loops.She reports progressively worsening abdominal pain since then located to periumbilical area.The patient currently rates the abdominal pain as an 8 out of 10.She states that she has an appointment with the surgeon in 3 days, but she states that the pain is too severe to wait until then.The patient reports that she was prescribed hydrocodone for the pain but experienced associated nausea.She states that she was switched to tramadol but denies significant improvement of the pain.¿ on (b)(6) 2016: ¿the patient is a 36-year-old woman that i had seen last fall and performed a laparoscopic ventral hernia repair.She had had a midline incision for a c-section.It became infected and had undergone a repair of this.She had done well from that time but did have a recurrence of fluid.She had continued to have some discomfort on this and the thought was that perhaps the fluid was accounting for this.¿ ¿she underwent an ultrasound-guided aspiration of 125 ml of fluid in june of 2015.She had not had any problems until recently when she had pain in her lower abdomen.She was seen at (b)(6) hospital and diagnosed with a recurrent hernia.There was concern that her white blood count was up and whether she had evidence of a graft infection.¿ ¿a ct scan of this showed a ventral hernia just below the previous repair.The previous mesh was identified.It appears intact superiorly, but just in the lower aspect of her incision, it has a 7 cm opening with a large amount of small bowel protruding through this.The defect is 10cm below the umbilicus.¿ ¿the patient has not had fevers.She has not had redness around her incision.She has not had any drainage, but she has had pain and tenderness associated with this.Her white blood count has been mildly elevated to 14.1 with mild elevation of her sedimentation rate.¿ ¿her abdomen is obese.She does have a palpable mass on the inferior aspect of her previous incision.There is not redness.There is no drainage.I have told them at this point she has a recurrent hernia.I am not certain as to whether this is due to infection, which is a possibility.I have told them that i am encouraged that i do not see nor did the radiologist see fluid around her hernia or along the mesh.She also has no external signs of infection of this, but i have told her that infection is a possibility that if this is the case that we would need to remove the mesh and do a primary repair with a component separation technique.This would be a larger operation with doing it open and extending her dissection quite laterally to release the muscles, i also discussed with her that it may be as simple as a stitch coming loose in the lower aspect of the mesh and that this has allowed intestines to protrude out underneath this, or she may need another piece of mesh over this.I discussed with them and recommended they consider a repeat laparoscopic examination, that we look at the mesh and if the hernia is all below this, that we could conceivably repair this laparoscopically with another piece of mesh.I also discussed with her that it may mean a larger operation and it may require an open procedure even if there is not an infection.¿ on (b)(6) 2016: ¿comes with her abdominal hernia.It is giving her a lot of pain and problems.She has a marked rash over her abdomen.There are some open sores.She is currently undergoing treatment.I have recommended that we continue the antibiotic that the dermatologist had placed her on.We will anticipate repairing this in a week's time.¿ on (b)(6) 2016: ¿laparoscopic ventral hernia repair, resuturing a portion of the mesh.¿ ¿recurrent ventral hernia.¿ ¿a small incision was made in the right upper quadrant and a 5-mm trocar was placed using the optiview system.The abdomen was then distended with carbon dioxide, the scope inserted.There were a large amount of adhesions present.I was able to see a clear spot in the left upper quadrant and a second 5-mm trocar was placed.The adhesions were then dissected down and i placed a right lower quadrant trocar, 5 mm, and freed up the adhesions of the abdomen.¿ ¿there appeared to be a portion of the mesh that had pulled loose on the left lower side revealing a hernia sac.There was material in it that looked as gelled fluid.A catheter was placed in this.As i grasped this gel fluid it did rupture with blister-like fluid being present.This was suctioned and aspirated and sent for culture.The mesh was freed up from some adhesions.It was then resutured to the left lateral abdominal wall using interrupted prolene sutures.The edge was then tacked down with a tacking device.This covered the hernia without problems.The wounds were then closed with 4-0 vicryl in a subcuticular fashion.Sterile dressings were applied¿.On (b)(6) 2016: culture: ¿culture body fluid aerobic-no growth at 5 days.Culture, anaerobic-no anaerobic growth after 5 days.Culture: moderate growth escherichia coli, moderate growth mixed skin flora.¿ on (b)(6) 2016: emergency department: ¿she states she has a wound under her pannus which drained pus.She also noticed increased redness around the area.The patient recently had laparoscopic ventral hernia repair.She stales the area that is draining is not one of the surgical sites.She states she has pain to the area which is 7/10.She denies nausea, vomiting and abdominal pain.¿ ¿skin rash - treated for folliculitis for 2 years without improvement; dermatologist biopsied rash-superficial epidermal necrosis, mild follicular inflammation, spongiosis and marked papillary edema-no evidence of porphyria, lichen planus or fungal infection¿ ¿a small midline abdominal wound underneath the patient's pannus is present.This is not at the surgical site per the patient.It was not actively draining at the time i evaluated the patient.A small amount of surrounding sialitis was present.A yeast infection was also present.The patient does have psoriasis which is present on the abdomen.¿ ¿i feel the patient may have had a small subcutaneous abscess which ruptured and spontaneously drained.Surrounding cellulitis is present.No fluctuance or area to drain is present at the area of the wound.A surrounding [sic] used [sic] infection is present." ¿no evidence for postsurgical abscess or deep abdominal infection was present during the time of my evaluation.¿ on (b)(6) 2016: ¿[patient] comes following a ventral hernia repair.She had a small incision made in the previous cesarean section at the bottom of her scar.She complains it was draining.She has a marked area of a fungal infection over her skin.She was placed on antibiotics in the emergency room as well as clomitrazole.I have recommended she continue with this and not use the triple antibiotic on her skin as ¿it is keeping this area moist where her pannus overlaps this¿.On (b)(6) 2016: ¿[patient] wound looks much better after using the anti-fungal cream.It is not red.She has tenderness at the suture fixation points but otherwise is unremarkable.She complains of pain on the left side but i cannot feel any evidence of abnormality or other problems.¿ on (b)(6) 2016: emergency department: ¿ct abdomen pelvis - impression: 1.Ventral wall hernia in the lower pelvis without significant change compared to the prior ct.2.A peripherally enhancing area at the left ovary measuring 2.2 x 1.9 cm likely a corpus luteal cyst, new since the prior exam 3.No fluid in the abdomen or pelvis.¿ (b)(6) 2016: ct abdomen/pelvis: ¿abdominal wall: ventral hernia mesh material is again identified.Inferiorly, below the umbilicus, the left aspect of the mesh is retracted to the midline and there is a recurrent lower abdominal wall hernia above the symphysis pubis with loops of small bowel protruding through the hernia defect into the patient¿s lower pannus.There is no evidence of bowel obstruction.The upper aspect of the urinary bladder is in close proximity to the lower aspect of the abdominal hernia defect as seen previously.¿ on (b)(6) 2016: emergency department: ¿i saw her 4 days ago for the same pain.She ran out of vicodin yesterday and the pain is persistent.¿ ¿ct 4 days ago did show recurrence of ventral hernia.She plans on seeing the surgeon tomorrow and is just looking for pain medication to get her through until then.¿ explant preoperative complaints: on (b)(6) 2016: ¿a young female who has had a c-section and developed a wound infection followed by a hernia.She had a ventral hernia repair, laparoscopic x2 that failed.I saw her in clinic and we did discuss risks and benefits of an open ventral hernia repair with mesh.We discussed the need for panniculectomy at the same time to optimize the outcome.¿ explant procedure: ¿ventral hernia repair with mesh, retrorectus placement of prolene mesh, lysis of adhesions.¿ explant date: (b)(6), 2016, ¿plastic surgery began first and performed a panniculectomy.¿ ¿a 10-blade was used to incise the lower incision through the skin.This was dissected through subcutaneous tissue using bovie electrocautery until the abdominal wall was encountered laterally.Medially the planes were not very discrete due to the multiple surgeries and scar tissue present.Once, this was dissected as far medially as safe, a decision was then made to reflex the bed and double check the superior marks that were made in preoperative holding.¿ ¿the previous marks looks [sic] like there would be no problems with closure.A decision was made to make a top incision too, as this would allow us to approach the hernia circumferentially.The top incision was then made with a 10-blade through the skin and dissected through subcutaneous tissue using bovie electrocautery.Started laterally and lifted the entire pannus off the abdominal wall until we identified the hernia sac medially.¿ ¿this was carefully dissected using bovie and hemostat to avoid entering the hernia sac.The abdominal wall was then taken off the hernia sac and the total weight was 4383grams.Throughout the dissection, a few large subcutaneous veins were identified and these were controlled using 2-0 vicryl ties or 2-0 vicryl sutures.At this point, general surgery came in for their portion of the procedure.¿ ¿plastic surgery began first and performed a panniculectomy.¿ ¿we were intraperitoneal.We removed the old gore-tex mesh, it really was not stuck to anything.There really were not many intra-abdominal adhesions.We did some lysis of adhesions but it was quite minimal.We got into the posterior rectus sheath and identified the posterior rectus fascia up towards the umbilicus.Dissected into that space.¿ ¿of course, below the umbilicus it was more just peritoneal layer.Got down to cooper's ligament at the pelvis, and then went up the other side, again exposing this posterior rectus/peritoneal layer.Now we were satisfied that we were all the way to the edge of the rectus sheath.I now proceeded with closing this layer together.This was done with a 0 pds running from either direction.Even though this was "peritoneum" it came together quite nicely.None of the stitches pulled through, it really came together quite well.¿ ¿i felt comfortable this was a good barrier for the mesh that i could put in prolene mesh.I used a piece of 30 x 30 [cm] mesh that i had cut down to appropriate size of about 20 x 15 [cm].This was secured to cooper's ligament inferiorly.This was secured to the midline superiorly and then 1 on each side, right at the edge of the rectus.It was trimmed to size.A 19-french drain was placed.¿ ¿now, we closed the anterior rectus fascia.This was done with o pds also.We were very careful to make sure we get anterior rectus fascia and not just hernia sac components.This came together quite nicely.I did run one other layer of o pds of just some of the hernia sac which actually seemed quite strong.Now we trimmed off remaining hernia sac and fat using a ligasure.This gave us a nice hernia repair.We ensured hemostasis.¿ ¿i now turned the case back over to plastic surgery for closure of the panniculectomy.¿ ¿we were called back in to the room and then lifted the abdominal flap up to the costal margins laterally and the xiphoid superiorly.The bed was reflexed.It was felt that it was an especially significant amount of abdominal skin and an additional amount totaling 725 grams was resected mostly laterally to control for the dog ear.¿ ¿at this time, aggressive irrigation was performed as well as a hemostasis of the entire wound.General surgery had previously placed a 19-french drain which was then sent out through the pubic skin anteriorly.I placed 2 additional 15-french drains, one on each flank.Then 2-0 vicryl was used through scarpa's fascia, then lnsorb was used for deep dermal suture and a 3-0 monocryl subcuticular.Dermabond was placed on the wound.¿ ¿of note, the umbilicus was included with the resected specimen.General surgery did close the umbilical defect.The decision was made to take the umbilicus due to her history of multiple recurrent hernias and concern that if her umbilicus did not survive, it could potentially be a portal of infection towards her mesh.¿ records confirm ethicon prolene mesh, (non-gore device) was implanted during the procedure.Relevant medical information: (b)(6) 2016: ¿1.Sharp debridement of abdominal flap, 50cm x 4cm, x7cm deep.2.Vacuum assisted closure device.¿ ¿1.Abdominal skin necrosis.2.Intra-abdominal infection.¿ ¿[patient] underwent a panniculectomy with ventral hernia repair 2-1 /2 weeks ago.She had been discharged and subsequently developed increasing pain and change in drainage consistency.She was admitted to the hospital and found to have elevated white count and the drain fluid was growing enterococcus and mrsa.Her abdominal flaps have progressive areas of necrosis, which is due to a combination of infection as well as her positive cotinine test.She was taken to the operating room today for an i&d of her abdomen.¿ ¿the grossly necrotic tissue was outlined and this was incised with a 15 blade.It was noted that this was full-thickness abdominal centrally and this was debrided until bleeding tissue was obtained.2-0 nylon were placed in the wound laterally that was still intact due to the fact that the 3-0 monocryl subcuticular was now removed with the debridement.Once the intra-abdominal cavity was entered , it was noted there was a significant amount of very cloudy thick fluid.Her abdominal wall had hypergranulation tissue present.This was then copiously irrigated with 3 liters of pulse lavage.Due to the appearance, the decision was made to delay closure and to place a vacuum assisted closure device.Two black sponges were placed in the wound and the vac was set to 125 mm of continuous suction.¿ on (b)(6) 2016: ¿1.Sharp debridement of abdominal flap, 50cm x 4cm, x7cm deep.2.Vacuum assisted closure device.¿ on (b)(6) 2016: ¿sharp debridement of abdominal skin, fat necrosis and application of vac assisted closure dressing.¿ on (b)(6) 2016: ¿sharp debridement of 12 x 5 cm abdominal wound washout and primary closure.¿ on (b)(6) 2016: ¿excisional debridement of abdominal wall including skin and subcutaneous fat, 17 x 2.5 cm, and abdominal wall closure with drain placement.¿ conclusion: it should be noted that the gore® dualmesh® 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 instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ the instructions for use further state: ¿use only nonabsorbable sutures, such as gore-tex® suture, with a noncutting needle (such as taper or piercing point) of appropriate size to anchor the device.The use of absorbable sutures may lead to inadequate anchoring of gore® dualmesh® plus biomaterial to the host tissue and necessitate reoperation.For best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ 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.Medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.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: 8444111
• MDR Text Key: 139571328
• Report Number: 3003910212-2019-00049
• 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: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 118