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

Model Number 1DLMC06

Device Problems Use of Device Problem (1670); Microbial Contamination of Device (2303); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Fistula (1862); Unspecified Infection (1930); Nausea (1970); Pain (1994); Vomiting (2144)

Event Date 04/02/2007

Event Type  Injury  

Manufacturer Narrative

(b)(4).(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 parastomal hernia repair on (b)(6) 2003 whereby a gore dualmesh® biomaterial device was implanted.It was reported that on (b)(6) 2005, laparoscopic repair of a parastomal hernia was performed whereby another gore dualmesh® biomaterial device was implanted.According to the report, the patient underwent laparoscopic ventral hernia repair on (b)(6) 2006 whereby a third gore dualmesh® biomaterial device was implanted.The complaint alleges that on (b)(6) 2007, the gore devices were explanted, and two parastomal mesh devices were implanted.It was reported the patient alleges the following injuries: abdominal pain, nausea and vomiting, dense abdominal adhesions, adhesions to small bowel and colon, multiple bowel obstructions, small bowel perforation, hernia recurrence, additional surgeries to repair hernia, abdominal abscess, open draining wound, and mesh removal.Additional event specific information and medical records were not provided but have been requested.

Manufacturer Narrative

Corrected conclusion code.Added medical record summary.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to (b)(6) 2003, including prior abdominal procedures, were not provided.Operative records dated (b)(6) 2003 indicate the patient underwent repair of a peristomal hernia and incisional hernia.Postoperative diagnosis states: ¿peristomal hernia of ileal conduit.¿ the (b)(6) 2003 records state: ¿the peritoneal cavity was entered through his previous midline incision and near the umbilicus, as we went through the subcutaneous tissue, we encountered no fascia.It was then found with a finger being able to be placed into the peritoneal cavity that he had multiple fascia defects along the midline and these were incorporated as the previous incision was opened.With the midline open, several loops of jejunum which were tightly adherent to the opening were then taken down in order to allow complete mobilization of the bowel that was adherent to the midline.There was no bowel injury during takedown of these adhesions.With this done, the pelvis was gently palpated and there was no evidence of any recurrence of his tumor, no nodules were noted and no masses visualized.Next, attention was turned to the peristomal hernia which was located in the right lower quadrant.This was found to contain omentum as well as the right colon, cecum, appendix and a portion of the terminal ileum.This was able to actually be drawn back into the peritoneal cavity without any difficulty and there were no adhesions into the peritoneal sac.With this done, the defect was found to measure approximately 5-6 cm in diameter and had only the ileal conduit going up through it.The defect was actually lateral to the stoma.The posterior fascia of the rectus muscle was found to be slightly widened also on the medial aspect of the stoma.The adhesions were taken down so that the stoma was completely circumferentially dissected but again there was no injury to the stoma or it¿s mesentery.¿ the (b)(6) 2003 operative report states: ¿a piece of gore-tex mesh was then cut and measures 12 x 12 cm.It was then keyholed with a 3 cm hole in the middle.Prior to mesh repair of the defect, it was reapproximated with two interrupted sutures of 0 ethibond which were placed full thickness to reapproximate the fascial defect.However, the tip of the small finger could still easily be passed up alongside the stoma in order to avoid compromise of it.Next, the piece of keyholed mesh was placed around the stoma with the slit on the medial aspect towards the midline.It was then fixed in place using 4.8 mm staples circumferentially with a slight overlap in order to bring this around the stoma.After completely stapling it in place, it was then also fixed in place with several interrupted sutures of 2-0 ethibond in order to help reinforce the staples.The staples were placed along the lateral edges, as well as at several portions in the mid portions of the mesh which was obviously placed rough side up to promote the ingrowth.No sutures or staples were placed into the conduit itself.With this done, the abdomen was checked to ensure hemostasis and the midline was then closed with a running #2 prolene.The wound was copiously irrigated and the skin was closed with clips.A sterile dressing was applied.The stoma was pink following completion of the procedure and in the recovery room he was making large amounts of clear, yellow urine.¿ the records confirm a gore dualmesh® biomaterial (1dlmc06/02433055) was used during the procedure.Records between 12/10/2003 and 1/26/2005 were not provided.Operative records dated (b)(6) 2005 indicate the patient underwent exploratory laparotomy with adhesiolysis and reduction, mesh repair of peristomal hernia, and repair of perforated ileal conduit.Postoperative diagnoses state: ¿1.Peristomal richter hernia involving small bowel.2.Perforation of ileal conduit.¿ the (b)(6) 2005 records state: ¿the peritoneal cavity was entered through a midline incision revealing extensive adhesions to the omentum and multiple interloop adhesions.The omentum was freed from both the overlying peritoneum as well as the underlying loops of bowel so that it could be retracted in a cephalad fashion.This revealed multiple loops of bowel all tightly adherent which were taken down using metzenbaum scissors.While he did have some dilated loops of bowel there was no massive distention.However, as we worked down into the right lower quadrant it was noted that he appeared to have a moderate amount of clear fluid present within the pelvis and right lower quadrant.We in fact encountered several large pockets of this as the adhesions were taken down.¿ the (b)(6) 2005 operative report states: ¿eventually we reached the stoma of his ileal conduit and as we dissected around what to him would be the lateral cephalad portion of the ostomy site there was a loop of bowel which formed a richter type hernia with a single wall of the bowel stuck up in that location through the opening.This was able to be gently retracted down and while there was some ecchymosis on the bowel wall there was no evidence of ischemia, necrosis or perforation.This was retracted down.After mobilization of the loops of bowel his previous small bowel anastomosis was identified and was found to be patent.No other significant kinking of the bowel was noted and at this point the question was how to keep this from recurring.The patient had had a previous dual-sized piece of gore-tex mesh placed in a keyhole fashion around his much larger peristomal hernia which had been repaired in the past.At this time we were able to slip a fingertip alongside of the stoma and felt that this would have to be closed more tightly in order to prevent any type of recurrence.With a window around the stoma an additional piece of gore-tex dual-sided mesh was cut measuring approximately 8 x 8.5 cm and keyholed with a 2 cm hole.We measured the diameter of the stoma and it appeared to be approximately 2.5 cm.¿ the (b)(6) 2005 operative report continues: ¿this was then placed with the slit facing inferiorly or towards his pelvis and was fixed in place with interrupted sutures of 0 ethibond.The flaps were then overlapped slightly in order to provide a tight seal around the stoma but enough that it would still allow passage of a right angle clamp.This was tested several times.On the medial side we did place several serosal sutures to the mesh in an attempt to close the dead space around the conduit.When this was done we were providing a final dissection when it was noted that there appeared to be some, what was initially thought to be purulent material lateral to the conduit.There was just a slight amount of this but we had also noticed that there appeared to be a buildup of clear fluid, more than one would expect from third-spacing of the bowel building up.The patient had had a pure urine output throughout the case.Inspection of the ileal conduit did not show any obvious leaks; however, as we traced the stoma up through the mesh there appeared to be a small necrotic area on the back wall.It was at this time that dr.Heth was consulted.¿ the (b)(6) 2005 records state: ¿while i expect that he dictated a separate intraoperative consultation, essentially what happened is we prepped the ostomy site into the operative field and a red rubber catheter was placed down into the conduit.While this was being done the conduit was rolled in a cephalad fashion.There appeared to be a small perforation on the back wall of an area of what appeared to be initially some necrosis.Diluted blue dye was then injected and it did in fact show a perforation on the back of the conduit.This was repaired by dr.Heth in a double layer using initially 4-0 vicryl following by an imbricating layer of 3-0 vicryl.It was again tested and found to have no leaks.The red rubber catheter was then fixed in place using a nylon suture to the skin to stay in place as a wick.The abdomen was then irrigated copiously with saline, checked to ensure hemostasis and a #10 jackson-pruitt drain was brought out through a separate stab incision in the left lower quadrant.This runs down into the pelvis and is looped up towards the conduit but not in the area of his sutures.¿ the (b)(6) 2005 records continue: ¿the fascia was then closed with a 00 pds suture with ligation in the middle.It should be mentioned that the patient has known attenuated tissue in the midline and several small fascia defects were noted upon closure.The wound was again irrigated and the skin was closed with clips.The patient tolerated the procedure well.There were no known complications.¿ an addendum to the operative notes states: ¿prior to closure of the abdomen an omental patch was sewn by mobilizing the omentum and pulling it through the lateral window to the stoma in the vicinity of the repair and suturing it in place with an 0 ethibond suture.Following that abdominal closure was performed as dictated.¿ the records indicate a gore dualmesh® biomaterial (1dlmc02/02866844) was used during the procedure.Operative records dated (b)(6) 2006 indicate the patient underwent laparoscopic repair of a recurrent ventral hernia with mesh.The records state: ¿this is a 58-year-old male with history of bladder cancer, who has undergone a bladder resection with creation of an ileal conduit.He has had multiple operations complicated by hernias related to peristomal hernia as well as ventral hernias, as well as bowel obstructions.He now presents with a large recurrent ventral hernia.¿ the (b)(6) 2006 operative report states: ¿i was able to identify a fair amount of small bowel and colonic adhesions to the large ventral hernia as well as the omental adhesions.The left lateral aspect of his the abdomen appeared relatively free of adhesions.I was able to place two 5 mm versastep trocars.One was placed above the hassan trocar, the second was placed below the hassan trocar.Adhesions were very dense and appeared to be multiple small bowel adhesions tightly adherent to the abdominal wall, i, therefore, elected to sharply take these down with a metzenbaum scissors.Once the small bowel adhesions were all taken down, i was then able to use the harmonic scalpel on a large amount of omental adhesions.Ultimately, i was able to identify the entire fascial defect and cleared the intact fascia several centimeters out from the hernia itself.I was able to clear this down to the ileal conduit were a previously placed piece of mesh was identified.Once this was completed, i then reduced the intra-abdominal pressure down to 8 mmhg, measured the fascial defect and ultimately in order to have at least a 3 to 4 cm overlap, i used the largest gortex [sic] dual mesh of 18 cm x 24 cm, i placed a total of six 0 nurolon stitches along the periphery, then rolled the mesh into a cigar, removed the hassan trocar, placed it through the abdominal wall, placing it into the abdomen, then replaced the hassan trocar, regained pneumoperitoneum.¿ the (b)(6) 2006 records continue: ¿i then was able to laparoscopically unroll this piece of mesh.The rough side of the mesh was placed anteriorly towards the anterior abdominal wall, i started by placing the far right lower quadrant stitch near the ileal conduit.A total of six small counter incisions were made along the periphery of the circumference of the mesh.The excel suture passer was used to pull each tail of the nurolon stitch through these counter incisions.Hemostats were used to secure them.This was done circumferentially starting to the far right lateral inferior superior and finally on the left lateral aspect closest to the previously placed trocars.I was able to visualize this easily.There was good overlap and the entire defect was well covered.I then used pro-tacker's and placed a pro-tack every centimeter along the periphery.In order to do this successfully, i did place an additional 5 mm trocar in the far right upper quadrant.After initial gore-tex was placed along the circumference, along the periphery of the mesh, i then placed a second layer closer to the edge of the defect, however, keeping this still outside the defect and a second ring was made circumferentially.Once this was completed and it appeared to be in good position, i then confirmed good hemostasis, removed the 5 mm versastep trocars, again confirmed hemostasis, removed the hassan trocar, lost all pneumoperitoneum.I closed this fascial defect with interrupted figure-of-eight o vicryl stitches.¿ the records confirm a gore dualmesh® biomaterial (1dlmc06/04380897) was used during the procedure.Operative records dated (b)(6) 2007 indicate the patient underwent repair of an incarcerated recurrent peristomal hernia.The records state: ¿this is a 58-year-old male, who has had multiple ventral hernia repairs.He has an ileal conduit secondary to bladder cancer and has had previous peristomal hernias repaired in the past with mesh, also a large ventral hernia which i repaired last december 2006 with a large sheet of gore-tex duomesh.This was performed laparoscopically.Patient also has had multiple bowel obstructions requiring adhesiolysis.He presents with bowel obstruction since yesterday with nausea, vomiting, fever and chills.Ct scan was performed and revealed a knuckle of distal ileum caught within a peristomal defect.There also appears to be dilatation of his ileal conduit from the fascia proximally likely due to extrinsic compression due to the incarcerated loop of bowel.¿ the (b)(6) 2007 records state: ¿a midline incision was made, carried down through the area of the previous laparoscopic mesh repair.After opening through the mesh.There was a larqe capsule area identified.This was adhesed to the periphery of the mesh circumferentially.Protacks were identified.Some of the rough protacks that were not well covered with peritoneum were removed with the hemostat.I was able to take down the adhesions of the peritoneum along the right lateral aspect of the mesh using a metzenbaum scissors.I continued the dissection laterally.I was able to reach the old peristomal mesh that was in place and there were some adhesions to this.These were sharply taken down.I was able to identify the ileal conduit which was quite distended extending posteriorly towards the pelvis.I followed this up to its opening in the fascia and then i was able to identify the knuckle of ileum that was caught within the opening.This was sharply taken down using the metzenbaum scissors.Ultimately, i was able to release the bowel and then this then allowed decompression of the ileal conduit the defect was only slightly larger than the tip of my index finger, i did place an additional #1 prolene figure-of-eight stitch to slightly diminish the size of the defect, however, knowing that a large enough defect had to be allowed to allow the ileal conduit to properly drain.At the conclusion of closing the defect, i was now only able to place the tip of my little finger within the defect site, i irrigated with saline, i then took some omentum that was hanging down in this area and tacked it to the ileal conduit, trying to create a shield from further incarceration of bowel within this small defect.This was done using 3-0 pds suture.I again irrigated with saline, confirmed hemostasis and closed the midline incision with #1 prolene from above as well as below.This was done closing the divided mesh, incorporating some of the subcutaneous tissues with it.I then irrigated with saline in the subcutaneous tissue.There was a fairly thin amount of adipose tissue due to his previous multiple hernias.I then closed the superficial subcutaneous tissue with a running 3-0 vicryl and the skin was closed with a running 4-0 monocryl in a subcuticular fashion.¿ operative records dated (b)(6) 2007 indicate the patient underwent repair of a small bowel perforation, excision of abdominal wall mesh, and drainage of abdominal abscess.The postoperative diagnosis states: ¿perforated viscus.¿ the records state: ¿(b)(6) is a 58-year-old gentleman with a previous history of bladder carcinoma who has an ileal conduit and has had problems with peristomal hernia.He recently presented with an incarcerated recurrent peristomal hernia on (b)(6) 2007, repaired by dr.Hower.On the morning of (b)(6) 2007, he stood and had the drainage of succus out of his mid line incision.The wound was open and was noted to have succus entericus draining from his midline incision.¿ the (b)(6) 2007 records state: ¿the mid line incision was opened and all the previous suture was removed.The gore-tex mesh was completely encapsulated with small bowel contents and quite bilious stained all over.I, therefore, removed all of the of gore-tex mesh with all of the protack staples.I then dissected down the right lower quadrant where the bowel content seemed to be coming forth from.There was an abscess present there with pus and stool, and this was all washed out, and i eventually came upon the full thickness perforation on the antimesenteric side.The edges were freshened up and then i closed this transversely with a full layer thickness 3-0 pds, followed by interrupted lembert 3-0 silk sutures.Immediately adjacent to this in a kinked portion of small intestine was another small area of perforation which had been leaking as well, and this was sutured in the identical manner.¿ the (b)(6) 2007 records state: ¿during the course of retraction and exposure, i created an enterotomy on a loop of small intestine which the loop was completely adherent to the lower midline incision and was extremely friable.This was not secondary to excessive force retraction but simply "fell apart" and, therefore, was repaired primarily again with a transverse running 3-0 pds suture followed by interrupted 3-0 silk sutures.Given the fact that the patient did not have a lot of abdominal pain prior to this and could not clinically tell us that there was a significant problem, i elected to place a drain in the right lower quadrant to monitor in the immediate postoperative period.A 19 blake drain was placed.The abdomen was copiously irrigated out with sterile saline followed by some antibiotic-laden saline.I then closed the mid line fascia with two separate running #1 double-stranded pds sutures.The subcutaneous tissue was packed open.A new ileal conduit device was applied.¿ operative records dated (b)(6) 2008 indicate the patient underwent laparoscopic repair of a large recurrent ventral hernia and dense adhesiolysis (two hours).The records state: ¿fifty-nine-year-old male with a previous history of bladder cancer; has undergone a ileo conduit.He has developed ventral hernias from his previous mid line incision as well as parastomal hernias.He has had previous repairs outside our institution.I ultimately performed a laparoscopic ventral hernia repair in december of 2006.He did well, however, in april he returned to our emergency room with evidence of an incarcerated recurrent parastomal hernia.A midline incision was made through the gore-tex mesh.A richter's hernia was identified.A knuckle of small intestine was pulled from the hernia defect.The defect was closed with a single stitch.Five days later he developed peritonitis and had a small bowel perforation at the site of the previous richter's hernia.As a result his entire previous gore-tex dual mesh had been removed and the wound was allowed to granulate in.He is now here for definitive ventral hernia repair.¿ the (b)(6) 2008 records state: ¿there was a large amount of omental adhesions to the left upper quadrant, but ultimately i was able to work around to the far left lateral and was able to place a 5 mm working versastep trocar and then started taking down these dense adhesions of the small bowel to the abdominal surface as well as used a harmonic on all of the omentum that was quite adhesed to the left upper quadrant once i had performed over two hours of dense adhesiolysis of the small bowel and assured myself that there was no obvious injury i then deflated the pressure intraabdominal down to 8.I then measured the size of the defect and ultimately with proper overlap a 20 x 30 cm <____> [sic] composite mesh was used.An o nurolon stitch was placed in each corner.It was rolled into a cigar and passed through the hasson trocar.At this point i also had a left lower 5 mm trocar, so there was a total of two 5 mm trocars and the hasson trocar.I was able to unroll the mesh, made a small counterincision just above the ileo conduit and used the excel suture passer to grasp the far right lateral nurolon stitches.Each were brought up separately.This was done for each corner.The mesh was somewhat big and ultimately i did place an additional 0 nurolon stitch to the far right upper quadrant i then used a protack and was able to place protack every cm on the periphery of the wound as well as several throughout the mid portion of the graft, however, keeping attention to stay away from the fascial edges within the defect.I also used some of the absorbant tacks intermittently.¿ the (b)(6) 2008 records continue: ¿once this was all in place there was good overlap.I should note, however, in order to complete placement of all the protack i did place another 5 mm versastep trocar and this was placed in the right upper quadrant, again done under direct vision.At this point i then irrigated and aspirated the abdominal cavity being sure i did not miss any obvious potential enterotomies, and all appeared well.¿ product identification records for the mesh used during the (b)(6) 2008 procedure were not provided.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2003: (b)(6), md.Radiology ¿ ct abdomen/pelvis.Indication: [ni].Findings: ostomy right lower quadrant.Contrast containing bowel does herniate through the abdominal wall defect.This was apparent at prior examination.Impression: some sigmoid diverticula.Some herniation of bowel at ostomy site.(b)(6) 2003: (b)(6), md.Office notes.Urology.Exam: hernia right side at stoma, not clearly a peristomal hernia.Extends fairly extensively on the right.Impression/plan: follow up ct today was clear for any evidence of new disease.Consultation with dr.(b)(6).(b)(6) 2003: (b)(6), md.Office notes.Peristomal hernia, scheduled for repair.I obtained consultation with dr.(b)(6) and dr.(b)(6).I stated, in general, switching the stoma to the other side has not been shown to have long-term success rate at preventing herniation in future, but occasionally sutures can be placed on the inside, but very often mesh with bilaminar material has good results.I agreed with his recommendation from dr.(b)(6) that a midline incision be made.He is well-informed by his general surgeon doctor, and is cognoscente of risks, benefits, spectrum of options, we will proceed.(b)(6) 2003: (b)(6), md.Office notes.Evaluation prior to repair of peristomal hernia.Developed peristomal hernia from his ileal conduit.Ct showed multiple loops of bowel in the peristomal area.Abdomen: well-healed midline incision.Ideal [sic] conduit right lower quadrant with soft semi-reducible mass at lateral aspect.Operative repair again reviewed.He and i have had several discussions regarding approach and he also discussed with other surgeons, he is comfortable proceeding through a midline incision.Unfortunately, it would appear that peristomal incisions would only lead to problems with postoperative contamination of incision and repair of the hernia site as well as mesh reinforcement have also been discussed.He wishes to proceed.Understands risks of bleeding, infection, potential injury to the stoma or ureters.(b)(6) 2004: (b)(6), md.Radiology ¿ ct abdomen/pelvis.Indication: [ni].Findings: we again note some herniation at the ostomy site in right lower abdomen.Images through lower abdomen, pelvis show multiple metallic clips.(b)(6) 2005: (b)(6), md.Operative report.Addendum: ¿prior to closure of the abdomen an omental patch was sewn by mobilizing the omentum and pulling it through the lateral window to the stoma in the vicinity of the repair and suturing it in place with an 0 ethibond suture.Following that abdominal closure was performed as dictated.¿ (b)(6) 2006: (b)(6), md.Office notes.Urology.Now 5 years status post radical cystoprostatectomy, ileal conduit.Conduit has had problems with herniation but otherwise he has done well.Abdomen: easily reducible parastomal hernia.(b)(6) 2006: (b)(6), md.Radiology ¿ ct abdomen/pelvis.Indication: carcinoma of bladder follow-up, has an ileal loop diversion.Findings: some element of partial obstruction may be present as the proximal loop of bowel going into the hernia is slightly greater caliber than exiting hernia.Impression: a small paraumbilical hernia noted with contrast-filled small bowel extending into the hernia.A broad-based umbilical hernia is again apparent.(b)(6) 2006: (b)(6), md.Office notes.Family practice.Had significant bloating, some abdominal fullness 2 days ago.Has had episodes recurrent abdominal pain.(b)(6) 2005 had recurrent surgery due to obstruction.Also had a perforation of ileal conduit that required repair.Exam: little tender left lower quadrant.Impression: possible partial small bowel obstruction that is now resolving.Plan: observation.(b)(6) 2006: (b)(6), md.Radiology ¿ x-ray abdomen.Indication: abdominal pain, possible bowel obstruction.Impression: single mildly dilated loop of small bowel in midabdomen.Appearance is indeterminate.Early small bowel obstruction could be considered if there are persistent symptoms.(b)(6) 2006: (b)(6), md.Office notes.Several laparotomies for stomal hernia repair as well as ileal conduit leak on last laparotomy.Has known hernia disease of anterior abdominal wall, relatively asymptomatic.Has been working quite hard with exercise to manage weight.Recent episode left lower quadrant pain, distention.Abdominal examination shows some midline hernias, soft, easily reducible, currently not a problem.Impression/plan: currently doing well.Follow-up as needed.(b)(6) 2006: (b)(6), md.Office notes.Underwent second exploratory laparotomy with again revision of the mesh around his stoma.It was noted at first laparotomy for the peristomal hernia that the fascia was quite attenuated.At that time it was expected he would likely develop an incisional hernia.This has in fact happened.Peristomal area appears intact but midline incision has progressive herniation.Exam: large fascial defect with a smaller one below and no palpable defects near the bottom portion of incision.Impression/plan: incisional hernia which will likely require somewhat of a more complicated procedure given the proximity of his conduit and its mesh.(b)(6) 2006: (b)(6), md.Office notes.Recurrent hernia.Has had additional operations for recurrent hernias, i believe at least 2 pieces of mesh are in place.Abdomen: visible epigastric hernia.On palpation of the defect it is approximately 11 cm x 15 cm.It extends towards the stoma, however it does not appear to involve the stoma itself.I can feel a ridge of normal fascia few inches from stoma itself.Defect is large, easily reducible.Impression: ultimately i would recommend repair.I could attempt to perform laparoscopic repair.I have found it is more difficult to perform these repairs whenever there is history of mesh in place because the small bowel can become quite adherent to the mesh and is quite difficult to excise this laparoscopically.However, diagnostic laparoscopy could be performed and subsequently if adhesions appear amenable to laparoscopic repair i certainly feel that this would be a better repair for him, it would be less risk of infection due to large size of mesh that will be required and hopefully will facilitate his healing and hopefully prevent further recurrences.I did state that i was unsure if i would be able to perform it laparoscopically and ultimately would decide intraoperatively and if converted to open operation is necessary this would be done.I did discuss high risk of potential injury to small bowel due to the possibility of quite dense adhesions and this would ultimately prevent me from being able to place mesh, however a biologic type mesh could subsequently be used if needed.At this point the patient does not desire repair immediately.He is also unsure if this has increased in size the past 6 months.I have ultimately recommended he undergo hernia repair sooner than later but at this time it does not work well for him to have surgery, will plan for return to office 1 month.He does not wish to miss further work as it does affect his overall retirement plan.If we notice he is having more symptoms he needs to undergo repair.If hernia is enlarging in size in 1 month followup, he should undergo repair.If it is similar size, will try to wait until december.Patient is in agreement, understands risks involved with waiting.(b)(6) 2006: (b)(6), md.Office notes.Has developed large ventral hernia defect.Has not noticed changes in size of hernia.Exam: abdomen has multiple scars.Ileoconduit in right lower quadrant has a 14 x 10 cm fascial defect in the epigastric region in area of previous repairs.Impression: stable, large, recurrent ventral hernia.We have again discussed repair.Patient would like to do this electively first week of (b)(6).(b)(6) 2006: (b)(6), md.Office notes.Exam: large ventral hernia from xiphoid process to umbilicus.Incisions are well healed.Impression: i recommend he undergo repair due to the multiple episodes of recurrence he has had.Will attempt laparoscopic ventral hernia repair.He understands there is high risk we will need to convert to open operation due to large size of hernia as well as potential adhesions that would keep me from being able to perform the operation laparoscopically.He understands risks include, but not limited to bleeding, infection, recurrence, high probability procedure cannot be performed laparoscopically and would need to convert to open operation.Also a high risk of injury to intra-abdominal organ which may result in inability to perform any type of repair due to risk of infecting mesh.High risk of recurrence, high risk of intra-abdominal organ injury, inability to perform laparoscopically due to multiple adhesions, that are formed from previous repairs as well as previous mesh placements.Understands he is at risk of recurrence with his tobacco use.Understands that if open repair is necessary, this will require a large incision, a large piece of mesh will be placed.Risk of infections related to open incision.Likelihood of drains being required to diminish size of the seroma.Understands that [if] laparoscopic repair, a large seroma will develop and may be persistent.Usually these will slowly subside over time and hopefully not require aspiration.He understands all these risks and wishes to proceed.(b)(6) 2006: (b)(6), md.Operative report.Preoperative diagnosis: recurrent ventral hernia.Postoperative diagnosis: recurrent ventral hernia.Procedure: laparoscopic repair of recurrent ventral hernia with 18 x 24 cm gore-tex dual mesh.Indications: this is a 58-year-old male with history of bladder cancer, who has undergone a bladder resection with creation of an ileal conduit.He has had multiple operations complicated by hernias related to peristomal hernia as well as ventral hernias, as well as bowel obstructions.He now presents with a large recurrent ventral hernia.Findings: ¿patient had dense adhesions to the anterior abdominal wall.These were sharply taken down with a laparoscopic metzenbaum scissors as well as the harmonic scalpel.I was able to identify a previously placed piece of gore-tex mesh around his ileal conduit.I was able to dissect down to this mesh as well as down to the ileoconduit, but did not need to dissect around the ileoconduit.The hernia was more medial from the ileal conduit.It did not appreciate any obvious peristomal hernia.In order to adequately repair this large midline ventral hernia, an 18 x 24 cm piece of gore-tex dual mesh was used for the repair.A total of 6 sutures were placed around the periphery of this for anchoring as well as ultimately two rows of pro-tacks along the circumference.¿ description of procedure: ¿the patient was brought to the operating room, placed in supine position on the table.General endotracheal anesthesia was administered.H was prepped and draped in the usual sterile fashion.I should note that a sterile bag was placed over his ileal conduit.Once he was prepped and draped, i also placed an ioban over the right lateral aspect of the abdomen, including the ileoconduit bag and applied.I started by making a left upper quadrant transverse incision just below the costal margin and carried this down, separating the various muscle layers until i reached peritoneum.This was then opened, finger was inserted.There was a free space.I then placed a pds figure-of-eight vicryl stitch on the edges of the peritoneum, inserted the hassan trocar and then gained pneumoperitoneum.I was able to identify a fair amount of small bowel and colonic adhesions to the large ventral hernia as well as the omental adhesions.The left lateral aspect of his the [sic] abdomen appeared relatively free of adhesions.I was able to place two 5 mm versastep trocars.One was placed above the hassan trocar, the second was placed below the hassan trocar.Adhesions were very dense and appeared to be multiple small bowel adhesions tightly adherent to the abdominal wall.I, therefore, elected to sharply take these down with a metzenbaum scissors.Once the small bowel adhesions were all taken down, i was then able to use the harmonic scalpel on a large amount of omental adhesions.Ultimately, i was able to identify the entire fascial defect and cleared the intact fascia several centimeters out from the hernia itself.I was able to clear this down to the ileal conduit were a previously placed piece of mesh was identified.Once this was completed, i then reduced the intra-abdominal pressure down to 8 mmhg, measured the fascial defect and ultimately in order to have at least a 3 to 4 cm overlap, i used the largest gortex [sic] dual mesh of 18 cm x 24 cm, i placed a total of six 0 nurolon stitches along the periphery, then rolled the mesh into a cigar, removed the hassan trocar, placed it through the abdominal wall, placing it into the abdomen, then replaced the hassan trocar, regained pneumoperitoneum.¿ i then was able to laparoscopically unroll this piece of mesh.The rough side of the mesh was placed anteriorly towards the anterior abdominal wall.I started by placing the far right lower quadrant stitch near the ileal conduit.A total of six small counter incisions were made along the periphery of the circumference of the mesh.The excel suture passer was used to pull each tail of the nurolon stitch through these counter incisions.Hemostats were used to secure them.This was done circumferentially starting to the far right lateral inferior superior and finally on the left lateral aspect closest to the previously placed trocars.I was able to visualize this easily.There was good overlap and the entire defect was well covered.I then used pro-tacker¿s and placed a pro-tack every centimeter along the periphery.In order to do this successfully, i did place an additional 5 mm trocar in the far-right upper quadrant.After initial gore-tex was placed along the circumference, along the periphery of the mesh, i then placed a second layer closer to the edge of the defect, however, keeping this still outside the defect and a second ring was made circumferentially.Once this was completed and it appeared to be in good position, i then confirmed good hemostasis, removed the 5 mm versastep trocars, again confirmed hemostasis, removed the hassan trocar, lost all pneumoperitoneum.I closed this fascial defect with interrupted figure-of-eight 0 vicryl stitches.Marcaine 0.5% was injected into the subcutaneous tissues and staples were used to close the skin.A new ileal conduit appliance was placed.An abdominal binder was then used.Patient was taken to the recovery room in stable condition.I should note that during the operation, there was no output via his ileal conduit, however, in the recovery room it started to make urine again¿.Complications: ¿none.¿ (b)(6) 2006: (b)(6).Procedure note.Pre-procedure diagnosis: recurrent ventral hernia.Post-procedure diagnosis: same.Procedure: laparoscopic repair of giant recurrent ventral hernia [with] 18 x 24 cm gore dual mesh.Findings: ¿large defect repaired [with] large mesh ileal conduit posterior to hernia-old mesh seen at ileal conduit.¿ specimens: [checked] none.Complications: [checked] none.Patient condition: [checked] stable.(b)(6) 2006: (b)(6).Implant sticker.Gore dualmesh® biomaterial.Ref catalogue number: 1dlmc06.Lot batch code: 04380897.W.L.Gore & associates.The records confirm a gore® dualmesh® biomaterial (1dlmc06/04380897) was implanted during the procedure.(b)(6) 2006: (b)(6).Photocopies.Endoscopy.4 photocopies.First [handwritten] defect.Second [handwritten] old mesh around ileal conduit.Last photocopy [handwritten] completed repair.[very poor-quality copies] (b)(6) 2006: (b)(6), md.Discharge summary.Discharge recommendations: no lifting greater than 15 pounds for full 6 weeks following date of surgery.Discharge medications: aspirin.(b)(6) 2007: (b)(6), md.Office notes.Initially had problems with constipation, resolved.Continues to wear abdominal binder at all times.Exam: incisions clean, dry, healing well.Removed all staples.Applied benzoin, steri-strips.Impression: overall doing very well.Continue to wear abdominal binder during the day, but he does not need to wear at night.May shower, bath is also okay at this point.I strongly urged him to continue to refrain from lifting greater than 15 pounds for a full 6 weeks from time of surgery, after which he can then resume his usual activities.No further follow up is necessary unless problems or concerns.(b)(6) 2007: (b)(6), md.Office notes.Staples removed by dr.Hower but one was missed underneath his appliance bag.He peeled this back and i could easily remove the staple.Appears to be doing well, is quite happy with the repair thus far.Dr.Hower¿s instructions reiterated.(b)(6) 2007: (b)(6), md.Office notes.Urology.We obtained a loopogram.It is significant for the extremely large area of mesh which is notable in abdomen.He has a little bit of lipping in l4-5 space.No filling defects or stenosis.Abdomen: laparoscopic wounds are well-healed.(b)(6) 2007: (b)(6), md.Radiology ¿ ct abdomen pelvis.Indication: abdominal pain.Impression: herniated loop of terminal ileum with moderate stool, dilation seen in small bowel just proximal to herniated loop.Concerning for small bowel obstruction.Moderate distention of ilioconduit [sic] with abrupt change in caliber as the conduit passes through the right interior abdominal wall.Concern for functional obstruction of ilioconduit [sic].This is likely related to the patient¿s anterior abdominal wall hernia containing a loop of small bowel.(b)(6) 2007: (b)(6), md.History and physical.Bowel obstruction.Developed right lower quadrant discomfort.Nauseated with vomiting.Has fever currently.Abdomen: difficult to examine due to patient¿s shaking chills but does have palpable bulge just lateral to ileal conduit.Mildly distended.Ct reveals parastomal hernia.Appears to be a knuckle of distal small bowel stuck within.Wbc 18.9.Impression: incarcerated recurrent parastomal hernia around ileal conduit.Plan: or today for laparotomy and repair of parastomal hernia.Appears to have probably a temporary obstruction due to the incarcerated loop of bowel on his ileal conduit causing what may be some urosepsis or bacteremia.Has lots of mesh in place already and i will try to proceed without additional mesh.I discussed multiple risks, benefits, alternatives with patient and wife.Risks include but are not limited to bleeding, infection, recurrence of hernia, recurrence of midline hernia, possible infection of hernias, possibility of injury to the conduit or small bowel which could require repair, possibility of resection of small bowel, wound infections, intraabdominal infections, recurrent hernias.Also understand risk of recurrent obstructions.They understand all of these risks and wish to proceed.(b)(6) 2007: (b)(6).Procedure notes.Pre-procedure diagnosis: incarcerated recurrent peristomal hernia.Post-procedure diagnosis: same.Procedure: exploratory laparotomy.Repair of recurrent peristomal hernia.Findings: ¿knuckle of distal ileum incarcerated in stoma, single prolene stitch to decrease defect after reduction completed.¿ complications: [checked] none.Patient condition: [checked] none.[date discrepancy] (b)(6) 2007: (b)(6), md.Operative report.Assistant: white.Preoperative diagnosis: incarcerated recurrent peristomal hernia.Postoperative diagnosis: incarcerated recurrent peristomal hernia.Procedure: repair of incarcerated recurrent peristomal hernia.Indications: this is a 58-year-old male, who has had multiple ventral hernia repairs.He has an ileal conduit secondary to bladder cancer and has had previous peristomal hernias repaired in the past with mesh, also a large ventral hernia which i repaired last december 2006 with a large sheet of gore-tex duomesh.This was performed laparoscopically.Patient also has had multiple bowel obstructions requiring adhesiolysis.He presents with bowel obstruction since yesterday with nausea, vomiting fever and chills.Ct scan was performed and revealed a knuckle of distal ileum caught within a peristomal defect.There also appears to be dilatation of his ileal conduit from the fascia proximally likely due to extrinsic compression due to the incarcerated loop of bowel.¿.Findings: ¿this is a patient with adhesions surrounding the periphery of the gore-tex duomesh.There were several protacks that were removed from the mesh that appeared to have somewhat of a rough edge.I was able to dissect laterally towards the ileal conduit where the dilated ileal conduit was identified.Superior and posterior to this i was able to identify a knuckle of the most distal part of the distal ileum.With difficulty ultimately, i was able to free this.The defect was not very large.It was only slightly larger than my index finger.Ultimately, i elected to slightly decrease the size of this defect using a single figure-of-eight #1 prolene stitch.Now only my little finger was allowed into the defect.I then placed some omentum over this area to help prevent additional bowel from going back into the small opening.¿ description of procedure: ¿the patient was brought to the operating room, placed in the supine position onto operating room table.General endotracheal anesthesia was administered.He was prepped in the usual sterile fashion.A midline incision was made, carried down through the area of the previous laparoscopic mesh repair.After opening through the mesh.There was a large capsule identified.This was adhesed to the periphery of the mesh circumferentially.Protacks were identified some of the rough protacks that were not well covered with peritoneum were removed with the hemostat.I was able to take down the adhesions of the peritoneum along the right lateral aspect of the mesh using a metzenbaum scissors.I continued the dissection laterally.I was able to reach the old peristomal mesh that was in place and there were some adhesions to this.These were sharply taken down.I was able to identify the ileal conduit which was quite distended extending posteriorly towards the pelvis.I followed this up to its opening in the fascia and then i was able to identify the knuckle of ileum that was caught within the opening.This was sharply taken down using the metzenbaum scissors.Ultimately, i was able to release the bowel and then this then allowed decompression of the ileal conduit the defect was only slightly larger than the tip of my index finger, i did place an additional #1 prolene figure-of-eight stitch to slightly diminish the size of the defect, however, knowing that a large enough defect had to be allowed to allow the ileal conduit to properly drain at the conclusion of closing the defect, i was now only able to place the tip of my little finger within the defect site.I irrigated with saline.I then took some omentum that was hanging down in this area and tacked it to the ileal conduit, trying to create a shield from further incarceration of bowel within this small defect.This was done using 3-0 pds suture.I again irrigated with saline, confirmed hemostasis, and closed the midline incision with #1 prolene from above as well as below.This was done closing the divided mesh, incorporating some of the subcutaneous tissues with it.I then irrigated with saline in the subcutaneous tissue.There was a fairly thin amount of adipose tissue due to his previous multiple hernias.I then closed the superficial subcutaneous tissue with a running 3-0 vicryl and the skin was closed with a running 4-0 monocryl in a subcuticular fashion.Mastisol, steri-strips, and gauze were applied followed by a large rectangular tegaderm.Dressings were removed and i then was able to examine the ileal conduit.I removed the previous conduit appliance.The ileal conduit was pink, however, on the inferior edge there was some bruising and ischemia but the center of the ostomy was pink and well perfused as well the remaining of the periphery.Patient was then taken to the recovery room in stable condition.¿ specimens: ¿we did send the urinalysis at the conclusion of procedure.¿ complications: ¿none.¿ (b)(6) 2007: (b)(6).Progress notes.Febrile.Abdomen: minimal distention.Incision clean, dry.Wbc 19.1.Impression/plan: new fever but i do not think there is any intra-abdominal process occurring, but unsure where temperature is coming from.Maybe from his urosepsis-bacteremia.Change [antibiotics].Will also start lovenox.(b)(6) 2007: (b)(6).[signature illegible].Progress notes.Drainage of copious stool like material from wound.Wound opened with drainage of copious stool colored fluid.Plan: exploratory laparotomy and repair perforation.Discussed risks, benefits, including but not limited to bleeding, infection, organ injury, need for repair of ileal conduit, benefits of surgery, alternatives of non operative treatment, questions answered.Appears to understand and wishes to proceed.(b)(6) 2007: (b)(6), md.Operative report.Preoperative diagnosis: perforated viscus.Postoperative diagnosis: perforated viscus.Procedure: repair of small bowel perforation.Excision of abdominal wall mesh.Drainage, abdominal abscess.Indication: mr.Weckmueller is a 58-year-old gentleman with a previous history of bladder carcinoma who has an ileal conduit and has had problems with peristomal hernia he recently presented with an incarcerated recurrent peristomal hernia on (b)(6), 2007, repaired by dr.(b)(6).On the morning of (b)(6), 2007, he stood and had the drainage of succus out of his mid line incision.The wound was open and was noted to have succus entericus draining from his midline incision.¿ the wound was open and was noted to have succus entericus draining from his midline incision.Findings: ¿the previous gore dualmesh was completely encapsulated with small bowel succus material and was removed.There was pus and stool-like material in the right lower quadrant.The abdomen was quite hostile and stuck.There was a full thickness perforation on the antimesenteric side of the distal ileum with a secondary area immediately adjacent to this with a small pinhole of approximately 2 or 3 mm which was leaking.This was all repaired primarily.The abdomen was completely irrigated out over the involved areas.One full thickness new enterotomy was created at the time of this surgery right in the lower aspect of the midline incision where there was an adherent loop of bowel, which enterotomy occurred during the course of retraction and was repaired primarily.It was on an adjacent but separate loop of small intestine.¿ technique: ¿the patient was brought in the operating room, placed on the operating table in supine position.After the induction of a general endotracheal anesthesia, the patient was positioned, prepped and draped in the usual sterile fashion.I placed a 16 french foley catheter through the ileal conduit on the field, placed this to drainage.The midline incision was opened and all the previous suture was removed.The gore-tex mesh was completely encapsulated with small bowel contents and quite bilious stained all over.I, therefore, removed all of the of gore-tex mesh with all of the protack staples.I then dissected down the right lower quadrant where the bowel content seemed to be coming forth from.There was an abscess present there with pus and stool, and this was all washed out, and i eventually came upon the full thickness perforation on the antimesenteric side.The edges were freshened up and then i closed this transversely with a full layer thickness 3-0 pds, followed by interrupted lembert 3-0 silk sutures.Immediately adjacent to this in a kinked portion of small intestine was another small area of perforation which had been leaking as well, and this was sutured in the identical manner.During the course of retraction and exposure, i created an enterotomy on a loop of small intestine which the loop was completely adherent to the lower midline incision and was extremely friable.This was not secondary to excessive force retraction but simply "fell apart" and, therefore, was repaired primarily again with a transverse running 3-0 pds suture followed by interrupted 3-0 silk sutures.Given the fact that the patient did not have a lot of abdominal pain prior to this and could not clinically tell us that there was a significant problem, i elected to place a drain in the right lower quadrant to monitor in the immediate postoperative period.A 19 blake drain was placed.The abdomen was copiously irrigated out with sterile saline followed by some antibiotic-laden saline.I then closed the midline fascia with two separate running #1 double-stranded pds sutures.The subcutaneous tissue was packed open.A new ileal conduit device was applied.All final sponge, needle, and instrument counts were reported to be correct.The drain was sutured into place with a 3-0 nylon.The patient tolerated the procedure well and was discharged back to the pacu.¿.

Manufacturer Narrative

The investigation has been completed.In the absence of additional information or medical records from the complainant, this event will be closed with the information provided.Previous patient codes (1690, 1695, 1970, 1994, 2144, 2225, 2240, 2422, 2668) were reported based on the original complaint and are no longer applicable and/or not reportable per gore's investigation.The following information was determined from the medical records.Medical records: the known medical records span (b)(6) 2001 through (b)(6) 2018, and not all records received in this time span are relevant to the three implanted gore® dualmesh® biomaterial devices.Medical records from (b)(6) 2010 through (b)(6) 2012 and from (b)(6) 2015 through (b)(6) 2017 were not provided.Medical history: bladder cancer.Diverticulosis, polyps.Small bowel obstruction.Alcohol.On (b)(6) 2006 occasional alcohol use.On (b)(6) 2018 ¿couple glasses of wine every day.¿ smoking.On (b)(6) 2006 smokes a pipe, about one can of tobacco per week.On (b)(6) 2006 ¿understands he is at risk of recurrence with his tobacco use.¿ on (b)(6) 2009 ¿continues to smoke.¿ on (b)(6) 2018 daily pipe smoker.Obesity.On (b)(6) 2006 233 lbs., bmi 33.4.On (b)(6) 2008 240 lbs., bmi 34.4.On (b)(6) 2009 228 lbs., bmi 32.7.On (b)(6) 2012 205 lbs., bmi 29.4.On (b)(6) 2014 182 lbs., bmi 26.On (b)(6) 2018 166 lbs., bmi 24.Prior surgical procedures: on (b)(6) 2001: resection of large bladder lesion.On (b)(6) 2001: radical cystoprostatectomy with ileal conduit urinary diversion, bilateral pelvic lymph node dissection.On 2002 peristomal hernia repair, mesh placed [type not specified].Implant #1 preoperative complaints: on (b)(6) 2003 ¿hernia right side at stoma, not clearly a peristomal hernia.Extends fairly extensively on the right.¿ on (b)(6) 2003: ct abdomen: ¿some sigmoid diverticula.Some herniation of bowel at ostomy site.¿ on (b)(6) 2003: ¿developed peristomal hernia from his ileal conduit.Ct showed multiple loops of bowel in the peristomal area.Abdomen: well-healed midline incision.Ideal [sic] conduit right lower quadrant with soft semi-reducible mass at lateral aspect.Implant #1 procedure: repair of a peristomal hernia and incisional hernia.Implant: gore® dualmesh® biomaterial (1dlmc06/02433055, 18x24cm, ¿cut to 12cm x 12 cm¿).Implant #1 date: (b)(6) 2003 [hospitalization dates unknown].Description of hernia being treated: ¿the peritoneal cavity was entered through his previous midline incision and near the umbilicus, as we went through the subcutaneous tissue, we encountered no fascia.It was then found with a finger being able to be placed into the peritoneal cavity that he had multiple fascia defects along the midline and these were incorporated as the previous incision was opened.With the midline open, several loops of jejunum which were tightly adherent to the opening were then taken down in order to allow complete mobilization of the bowel that was adherent to the midline.Next, attention was turned to the peristomal hernia which was located in the right lower quadrant.This was found to contain omentum as well as the right colon, cecum, appendix and a portion of the terminal ileum.This was able to actually be drawn back into the peritoneal cavity without any difficulty and there were no adhesions into the peritoneal sac.With this done, the defect was found to measure approximately 5-6 cm in diameter and had only the ileal conduit going up through it.The defect was actually lateral to the stoma.The posterior fascia of the rectus muscle was found to be slightly widened also on the medial aspect of the stoma.The adhesions were taken down so that the stoma was completely circumferentially dissected but again there was no injury to the stoma or it¿s mesentery¿ implant size and fixation: ¿a piece of gore-tex mesh was then cut and measures 12 x 12 cm.It was then keyholed with a 3 cm hole in the middle.Prior to mesh repair of the defect, it was reapproximated with two interrupted sutures of 0 ethibond which were placed full thickness to reapproximate the fascial defect.However, the tip of the small finger could still easily be passed up alongside the stoma in order to avoid compromise of it.Next, the piece of keyholed mesh was placed around the stoma with the slit on the medial aspect towards the midline.It was then fixed in place using 4.8 mm staples circumferentially with a slight overlap in order to bring this around the stoma.After completely stapling it in place, it was then also fixed in place with several interrupted sutures of 2-0 ethibond in order to help reinforce the staples.The staples were placed along the lateral edges, as well as at several portions in the mid portions of the mesh which was obviously placed rough side up to promote the ingrowth.No sutures or staples were placed into the conduit itself.¿ implant #2 preoperative complaints: on (b)(6) 2004 ct abdomen: ¿we again note some herniation at the ostomy site in right lower abdomen.Images through lower abdomen, pelvis show multiple metallic clips.¿ implant #2 procedure: exploratory laparotomy with adhesiolysis and reduction, mesh repair of peristomal hernia, and repair of perforated ileal conduit.Implant: gore® dualmesh® biomaterial (1dlmc02/02866844, 8x12cm, ¿cut to 8cm x 8.5 cm¿) implant #2 date: (b)(6) 2005 [hospitalization dates unknown].Description of hernia being treated: ¿the peritoneal cavity was entered through a midline incision revealing extensive adhesions to the omentum and multiple interloop adhesions.¿ eventually we reached the stoma of his ileal conduit and as we dissected around what to him would be the lateral cephalad portion of the ostomy site there was a loop of bowel which formed a richter type hernia with a single wall of the bowel stuck up in that location through the opening.This was able to be gently retracted down and while there was some ecchymosis on the bowel wall there was no evidence of ischemia, necrosis or perforation.This was retracted down.After mobilization of the loops of bowel his previous small bowel anastomosis was identified and was found to be patent.No other significant kinking of the bowel was noted and at this point the question was how to keep this from recurring.The patient had had a previous dual-sized [sic] piece of gore-tex mesh placed in a keyhole fashion around his much larger peristomal hernia which had been repaired in the past.At this time we were able to slip a fingertip alongside of the stoma and felt that this would have to be closed more tightly in order to prevent any type of recurrence.¿ implant size and fixation: ¿with a window around the stoma an additional piece of gore-tex dual-sided mesh was cut measuring approximately 8 x 8.5 cm and keyholed with a 2 cm hole.We measured the diameter of the stoma and it appeared to be approximately 2.5 cm.¿ ¿this was then placed with the slit facing inferiorly or towards his pelvis and was fixed in place with interrupted sutures of 0 ethibond.The flaps were then overlapped slightly in order to provide a tight seal around the stoma but enough that it would still allow passage of a right angle clamp.This was tested several times.On the medial side we did place several serosal sutures to the mesh in an attempt to close the dead space around the conduit.¿ ¿diluted blue dye was then injected and it did in fact show a perforation on the back of the conduit.This was repaired by dr.(b)(6) in a double layer using initially 4-0 vicryl following by an imbricating layer of 3-0 vicryl.It was again tested and found to have no leaks.¿ relevant medical information: on (b)(6) 2006 urology: ¿conduit has had problems with herniation but otherwise he has done well.Abdomen: easily reducible parastomal hernia.¿ on (b)(6) 2006 ct abdomen: ¿a small paraumbilical hernia noted with contrast-filled small bowel extending into the hernia.A broad-based umbilical hernia is again apparent.¿ on (b)(6) 2006 ¿had significant bloating, some abdominal fullness 2 days ago.Has had episodes recurrent abdominal pain.¿ on (b)(6) 2006 abdominal x-ray: ¿single mildly dilated loop of small bowel in midabdomen.¿ on (b)(6) 2006 ¿recent episode left lower quadrant pain, distention.Abdominal examination shows some midline hernias, soft, easily reducible, currently not a problem.¿ on (b)(6) 2006 ¿incisional hernia which will likely require somewhat of a more complicated procedure given the proximity of his conduit and its mesh.¿ on (b)(6) 2006 ¿visible epigastric hernia.On palpation of the defect it is approximately 11 cm x 15 cm.It extends towards the stoma, however it does not appear to involve the stoma itself.I can feel a ridge of normal fascia few inches from stoma itself.Defect is large, easily reducible.¿ on (b)(6) 2006 ¿ileoconduit in right lower quadrant has a 14 x 10 cm fascial defect in the epigastric region in area of previous repairs.¿ implant #3 preoperative complaints: on (b)(6) 2006 ¿large ventral hernia from xiphoid process to umbilicus.I recommend he undergo repair due to the multiple episodes of recurrence he has had.¿ ¿understands he is at risk of recurrence with his tobacco use.¿ implant #3 procedure: laparoscopic repair of recurrent ventral hernia with 18 x 24 cm gore-tex dual mesh.Implant: gore® dualmesh® biomaterial (1dlmc06/04380897) implant #3 date: (b)(6) 2006 [hospitalization (b)(6) 2006] description of hernia being treated: ¿i started by making a left upper quadrant transverse incision just below the costal margin and carried this down, separating the various muscle layers until i reached peritoneum.This was then opened, finger was inserted.There was a free space.I then placed a pds figure-of-eight vicryl stitch on the edges of the peritoneum, inserted the hassan trocar and then gained pneumoperitoneum.I was able to identify a fair amount of small bowel and colonic adhesions to the large ventral hernia as well as the omental adhesions.The left lateral aspect of his the [sic] abdomen appeared relatively free of adhesions.I was able to place two 5 mm versastep trocars.One was placed above the hassan trocar, the second was placed below the hassan trocar.Adhesions were very dense and appeared to be multiple small bowel adhesions tightly adherent to the abdominal wall.I, therefore, elected to sharply take these down with a metzenbaum scissors.Once the small bowel adhesions were all taken down, i was then able to use the harmonic scalpel on a large amount of omental adhesions.Ultimately, i was able to identify the entire fascial defect and cleared the intact fascia several centimeters out from the hernia itself.I was able to clear this down to the ileal conduit where a previously placed piece of mesh was identified.¿ implant size and fixation: ¿once this was completed, i then reduced the intra-abdominal pressure down to 8 mmhg, measured the fascial defect and ultimately in order to have at least a 3 to 4 cm overlap, i used the largest gortex [sic] dual mesh of 18 cm x 24 cm, i placed a total of six 0 nurolon stitches along the periphery, then rolled the mesh into a cigar, removed the hassan trocar, placed it through the abdominal wall, placing it into the abdomen, then replaced the hassan trocar, regained pneumoperitoneum.I then was able to laparoscopically unroll this piece of mesh.The rough side of the mesh was placed anteriorly towards the anterior abdominal wall.I started by placing the far right lower quadrant stitch near the ileal conduit.A total of six small counter incisions were made along the periphery of the circumference of the mesh.The excel suture passer was used to pull each tail of the nurolon stitch through these counter incisions.Hemostats were used to secure them.This was done circumferentially starting to the far right lateral inferior superior and finally on the left lateral aspect closest to the previously placed trocars.I was able to visualize this easily.There was good overlap and the entire defect was well covered.I then used pro-tacker¿s and placed a pro-tack every centimeter along the periphery.In order to do this successfully, i did place an additional 5 mm trocar in the far-right upper quadrant.After initial gore-tex was placed along the circumference, along the periphery of the mesh, i then placed a second layer closer to the edge of the defect, however, keeping this still outside the defect and a second ring was made circumferentially.Once this was completed and it appeared to be in good position, i then confirmed good hemostasis, removed the 5 mm versastep trocars, again confirmed hemostasis, removed the hassan trocar, lost all pneumoperitoneum.I closed this fascial defect with interrupted figure-of-eight 0 vicryl stitches.¿ findings: ¿patient had dense adhesions to the anterior abdominal wall.These were sharply taken down with a laparoscopic metzenbaum scissors as well as the harmonic scalpel.I was able to identify a previously placed piece of gore-tex mesh around his ileal conduit.I was able to dissect down to this mesh as well as down to the ileoconduit, but did not need to dissect around the ileoconduit.The hernia was more medial from the ileal conduit.It did not appreciate any obvious peristomal hernia.In order to adequately repair this large midline ventral hernia, an 18 x 24 cm piece of gore-tex dual mesh was used for the repair.A total of 6 sutures were placed around the periphery of this for anchoring as well as ultimately two rows of pro-tacks along the circumference.¿ relevant medical information: on (b)(6) 2007 ¿appears to be doing well, is quite happy with the repair thus far.¿ on (b)(6) 2007 urology: loopogram: ¿significant for the extremely large area of mesh which is notable in abdomen.He has a little bit of lipping in l4-5 space.¿ explant [#3 device] preoperative complaints: on (b)(6) 2007 ¿bowel obstruction.Developed right lower quadrant discomfort.Nauseated with vomiting.Has fever currently.¿ on (b)(6) 2007 ct abdomen: ¿moderate distention of ilioconduit [sic] with abrupt change in caliber as the conduit passes through the right interior abdominal wall.Concern for functional obstruction of ilioconduit [sic].This is likely related to the patient¿s anterior abdominal wall hernia containing a loop of small bowel.¿ on (b)(6) 2007: exploratory laparotomy.Repair of incarcerated recurrent peristomal hernia.¿a midline incision was made, carried down through the area of the previous laparoscopic mesh repair.After opening through the mesh.There was a large capsule identified.This was adhesed to the periphery of the mesh circumferentially.Protacks were identified.Some of the rough protacks that were not well covered with peritoneum were removed with the hemostat.I was able to take down the adhesions of the peritoneum along the right lateral aspect of the mesh using a metzenbaum scissors.I continued the dissection laterally.I was able to reach the old peristomal mesh that was in place and there were some adhesions to this.I was able to identify the ileal conduit which was quite distended extending posteriorly towards the pelvis.I followed this up to its opening in the fascia and then i was able to identify the knuckle of ileum that was caught within the opening.This was sharply taken down using the metzenbaum scissors.Ultimately, i was able to release the bowel and then this then allowed decompression of the ileal conduit.The defect was only slightly larger than the tip of my index finger, i did place an additional #1 prolene figure-of-eight stitch to slightly diminish the size of the defect, however, knowing that a large enough defect had to be allowed to allow the ileal conduit to properly drain.At the conclusion of closing the defect, i was now only able to place the tip of my little finger within the defect site.I then took some omentum that was hanging down in this area and tacked it to the ileal conduit, trying to create a shield from further incarceration of bowel within this small defect.This was done using 3-0 pds suture.I again irrigated with saline, confirmed hemostasis, and closed the midline incision with #1 prolene from above as well as below.This was done closing the divided mesh, incorporating some of the subcutaneous tissues with it.I then irrigated with saline in the subcutaneous tissue.¿ on (b)(6) 2007: ¿drainage of copious stool like material from wound.Wound opened with drainage of copious stool colored fluid.¿ ¿he recently presented with an incarcerated recurrent peristomal hernia on (b)(6) 2007, repaired by dr.(b)(6).On the morning of (b)(6) 2007, he stood and had the drainage of succus out of his mid line incision.The wound was open and was noted to have succus entericus draining from his midline incision.¿ explant [#3 device] procedure: repair of small bowel perforation.Excision of abdominal wall mesh.Drainage, abdominal abscess.Explant [#3 device] date: (b)(6) 2007 [hospitalization (b)(6) 2007] ¿the midline incision was opened and all the previous suture was removed.The gore-tex mesh was completely encapsulated with small bowel contents and quite bilious stained all over.I, therefore, removed all of the of gore-tex mesh with all of the protack staples.I then dissected down the right lower quadrant where the bowel content seemed to be coming forth from.There was an abscess present there with pus and stool, and this was all washed out, and i eventually came upon the full thickness perforation on the antimesenteric side.¿ ¿immediately adjacent to this in a kinked portion of small intestine was another small area of perforation which had been leaking as well, and this was sutured in the identical manner.During the course of retraction and exposure, i created an enterotomy on a loop of small intestine which the loop was completely adherent to the lower midline incision and was extremely friable.This was not secondary to excessive force retraction but simply ¿fell apart¿ and, therefore, was repaired primarily again with a transverse running 3-0 pds suture followed by interrupted 3-0 silk sutures.¿ ¿a 19 blake drain was placed.The abdomen was copiously irrigated out with sterile saline followed by some antibiotic-laden saline.I then closed the midline fascia with two separate running #1 double-stranded pds sutures.The subcutaneous tissue was packed open.¿ on (b)(6) 2007 pathology: ¿abdominal wall mesh material, removal: mesh material with surrounding inflamed and necrotic tissue.¿ on (b)(6) 2007 microbiology: ¿positive for vancomycin resistant enterococcus gallinarum), rare candida albicans.¿ on (b)(6) 2007 discharge summary: ¿incarcerated recurrent peristomal hernia, urosepsis with bacteremia, perforation of small bowel with peritonitis.¿ relevant medical information: on (b)(6) 2007 ¿midline wound, which was left open, is doing very well.¿ on (b)(6) 2007 ¿wound has healed.¿ on (b)(6) 2007 ¿.Developed recurrent hernia at midline.Approximately a 7 x 11 cm defect in upper aspect of his midline excision [sic] extending in to right upper quadrant.¿ on (b)(6) 2007 ¿defect appears to be about 9 x 12 cm.¿ on (b)(6) 2008 ¿large hernia seems to be reducible, currently measuring about 12 x 15 cm.¿ on (b)(6) 2008 hospitalization.Laparoscopic repair of recurrent ventral hernia [with] 20 x 30 cm parietex composite mesh.Two additional hours of adhesiolysis.On (b)(6) 2009 ¿continues to smoke.¿ on (b)(6) 2014 ¿draining abscess on previous surgical scar.Continue localized care.¿ on (b)(6) 2014 ¿ileal conduit-enteric fistula.He has been seeing fecal-like material in catheter bag for over 1 year.¿ on (b)(6) 2014 fistulogram/ct abdomen: ¿short enterocutaneous fistula at site of small bowel adhesion to anterior abdominal wall.Enteroileal conduit fistula through space containing partially calcified, redundant surgical mesh.¿ explant [#1 & #2 devices] preoperative complaints: on (b)(6) 2014 ¿ct abdomen: large panel of mesh with abdominal wall tacks in place.Mesh measures 19 cm in craniocaudad and begins 6 cm above pubis, extends to 7 cm below xiphoid.Hernia defect is slightly smaller than the panel of mesh.Transverse colon appears intimately associated with mesh.¿ explant [#1 & #2 devices] procedure: enterolysis (three hours).Takedown of enterocutaneous fistula.Takedown of enteric-ileal conduit fistula.Explantation of infected anterior abdominal wall mesh.Takedown of ileal conduit.Small bowel resection with enteroenterostomy, side-to-side.Resection of ileal conduit.Isolation loop of small bowel for creation of ileal conduit.Excision of prior ileal conduit.Creation of new ileal conduit into the left lower quadrant.Explant [#1 & #2 devices] date: (b)(6) 2014 [hospitalization (b)(6) 2014 through (b)(6) 2014] ¿a primary upper midline incision was made above the level where ct predicted there might be small bowel adherent to the abdominal wall mesh.This incision was eventually extended inferiorly in an elliptical fashion to encompass the patient's previous midline abdominal incisional scar in the cutaneous portion of the enterocutaneous fistula.The peritoneal cavity was entered.Thankfully, there were no adhesions of small bowel or transverse colon to the undersurface of the anterior abdominal wall in the midline.A thin veil of omentum was adherent to the previously placed mesh.This was taken down with electrocautery.I then began to mobilize the previously placed mesh from the abdominal wall.This was a prolene-like panel.This was first taken down from the left abdominal wall.Attention was then directed to the right abdomen.The superior aspect of the mesh was dissected free of the undersurface of the anterior abdominal wall.There was a dense adhesive process in the right lower quadrant where multiple loops of small bowel were adherent to the undersurface of the anterior abdominal wall.With careful dissection, small bowel was taken down from the undersurface of the anterior abdominal wall, and ultimately a cavity was entered, which was filled with a large crumpled portion of stool stained mesh.Photographs were taken.The enterocutaneous fistula was intubated with a red rubber catheter, and with further dissection, we proved that this catheter entered the small bowel at the previous enteroenterostomy from patient's initial ileal conduit creation.It was initially difficult to identify the ileal conduit as this laid lateral to the small bowel involved in the enterocutaneous fistula.However, with further careful dissection, we recognized that the same stool stained mesh had eroded into the conduit itself, and indeed, came to occupy a portion of the intraluminal aspect of the conduit.¿ ¿dr.(b)(6) and i then mobilized the ileal conduit from the abdominal wall.This was rather tedious given the very redundant nature of the ileal conduit.At this time, the entire specimen was free.This compromised an en bloc specimen of the ileal conduit, the entirety of the anterior abdominal wall mesh with attached tacks, the small bowel encompassing the enteroenterostomy and the enterocutaneous fistula along with an ellipse of skin through which the fistula exited, and the appendix.¿ ¿ ¿it was immediately apparent that the stool-stained mesh was present and grossly invading into the lumen of the ileal conduit as well as the lumen of the small bowel.We were able to mobilize the butt end of the conduit out of the pelvis.We identified both ureters.These were ligated right where they entered into the conduit itself.This freed the conduit specimen, and the majority of the feculent debris was secured densely to this area.To remove the conduit itself we incised upon the mucocutaneous junction circumferentially and lysed adhesions from the subcutaneous fat to the conduit.This everted the conduit, and it was then removed en bloc with the remaining mesh, and adherent small bowel.After this had been completed dr.(b)(6) was able to identify an approximately 20-cm segment of ileum.¿ ¿findings: infected mesh eroded into the ileal conduit, with communicating enteric-ileal conduit fistula and enterocutaneous fistula.Involvement of appendix in inflammatory response.¿ on (b)(6) 2014 pathology report: ¿small bowel, ileal conduit, appendix, abdominal wall mesh, resection: skin, portions of small bowel and appendix with multiple fistula tracts associated with mesh, adhesions and acute inflammation.¿ ¿received fresh labeled ¿ileal conduit, portion small bowel, abdominal wall mesh¿ is a 17.7 x 2.8 cm tan skin ellipse with attached 31 cm ileal conduit, 17 cm portion of adherent small bowel, 9.7 x 1.1 cm adherent appendix, abundant adherent mesh.The skin displays a 0.5 x 0.3 cm fistula which is contiguous with a 5.5 x 1.8 cm small bowel ulcer.The ulcer is also contiguous with an ileal conduit fistula and a fistula between both portions of small bowel.A portion of the mesh has eroded into the ulcer.The mucosa surrounding the ulcer and fistulas is erythematous.¿ on (b)(6) 2014 ¿making progress but clearly has abdominal wall infection caused by previously infected mesh.¿ on (b)(6) 2014 ct abdomen: ¿small retropubic fluid collection, extends into posterior pelvis posterior to ileal conduit.Generalized small bowel dilation consistent with an ileus.¿ on (b)(6) 2014 debridement of open abdominal wound.Open drainage of suprapubic abscess.On (b)(6) 2014 ct abdomen: ¿interval decrease in size of the deep pelvic fluid collection.¿ on (b)(6) 2014 development of bilateral cutaneous/subcutaneous advancement flaps.Debridement of midline and right lower quadrant open abdominal wounds (60 cm2).Development of cutaneous/subcutaneous advancement flaps (200 cm2).Delayed primary closure of midline wound and right lower quadrant wound.(on b)(6) 2014 discharge summary: ¿home with home health services.Information for continuing care of ostomy and surgical incision.Home intravenous antibiotic therapy regimen.¿ relevant medical information: on (b)(6) 2014 ¿postoperative course complicated by suprapubic abscess related to intraoperative contamination.¿ on (b)(6) 2014 ct abdomen: ¿drained abscess.¿ on (b)(6) 2015 ct abdomen: ¿small recurrent abscess in right side pelvis, likely too small for drain but could be aspirated under ct guidance.¿ conclusion: 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.¿ the gore® dualmesh® biomaterial instructions for use also states, ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ the gore® dualmesh® biomaterial instructions for use also warns, ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ the gore® dualmesh® biomaterial instructions for use also states, ¿to help maintain strict asepsis during surgery, special precautions and extremely careful preoperative site preparations are necessary.When operative infection is suspected, dissection of involved tissues should be considered.Any postoperative infection should be aggressively treated at the earliest possible time.An unresolved infection may require removal of the material.Staged repairs should be considered when gore dualmesh® biomaterial will be subjected to gross contamination or infection.¿ the gore® dualmesh® biomaterial instructions for use also states, ¿cutting gore® dualmesh® biomaterial to the proper size is essential.Use sharp surgical instruments to trim the mesh.If gore® dualmesh® biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.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 devices were 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 lots met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE DUALMESH BIOMATERIAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7639203
• MDR Text Key: 112381789
• Report Number: 2017233-2018-00336
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00733132600991
• UDI-Public: 00733132600991
• 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: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2008
• Device Model Number: 1DLMC06
• Device Catalogue Number: 1DLMC06
• Device Lot Number: 02433055
• 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: 58 YR
• Patient Weight: 109