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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Obstruction/Occlusion (2422)
Event Date 02/27/2013
Event Type  Injury  
Manufacturer Narrative
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant #1 preoperative complaints: on (b)(6) 2008: pre-op diagnosis: ¿incisional hernia. ¿ implant #1 procedure: laparoscopic lysis of adhesions. Incisional hernia repair. Implantation of mesh for incisional hernia. [implant #1: gore® dualmesh® biomaterial, no information/no information, 18 x 24 cm. ], implant #1 date: (b)(6), 2008 [hospitalization dates unknown], wound classification: unknown. On (b)(6) 2008: (b)(6) system. (b)(6), md. Operative report. Pre-op diagnosis: incisional hernia. Post-op diagnosis: multiple fascial defects in the midline of abdomen. Anesthesia: general endotracheal. Estimated blood loss: minimal. Drains: none. Complications: none. Specimens: none. Procedure: ¿after the patient was identified, she was sterilely prepped and draped in the usual fashion. The abdomen was entered bluntly under direct visualization with the laparoscope using a blunt tip trocar in the left mid abdomen. Extensive adhesions of omentum to the underside of the abdominal wall were encountered. A 5 mm trocar was able to be placed in the left upper quadrant under direct visualization and then the underside of the abdomen was cleared using blunt, sharp and harmonic scalpel dissection. A 12 mm trocar was placed in the lateral right upper quadrant. The underside of the fascia was identified and there was a large periumbilical defect, another in the lower midline extending to the right and two smaller ones just above the umbilicus. All of these were repaired with one piece of gore-tex dual mesh 18 x 24 cm with prolene sutures tied to its corners which were brought out through stab wounds and tied down in the subcutaneous space to hold it to the underside of the fascia. An additional suture was pieced in the lover midline suprapubic area to held the lower edge of the mesh. The circumference of the mesh was then tacked to the fascia with the protack device. The abdomen was irrigated, aspirated, inspected for bleeding or injury and none was found so the ports were removed and the abdomen allowed to desufflate. The three laparoscopic incisions were closed with subcuticular vicryl and the stab wounds for the sutures were closed with steri-strips. The patient tolerated the procedure well, was taken to the recovery area in stable condition. ¿ revision #1, and implant #2 and #3 preoperative complaints: on (b)(6) 2009: pre-op diagnosis: ¿ventral hernia. ¿ revision #1, and implant #2 and #3 procedure: laparoscopic lysis of adhesions. Laparoscopic repair of incisional hernia in the upper midline. Laparoscopic incisional hernia repair in the right lower quadrant. Implantation of gore-tex dualmesh for both separate hernias. [implant #2: gore® dualmesh® biomaterial, no information/no information, 18 x 18 [sic]; implant #3: gore® dualmesh® biomaterial, no information/no information, 18 x 19 [sic]. ]; revision #1, and implant #2 and #3 date: (b)(6), 2009 [hospitalization dates unknown] wound classification: unknown. On (b)(6) 2009: (b)(6) system. (b)(6), md. Operative report. Pre-op diagnosis: ventral hernia. Post-op diagnosis: ventral hernia with incisional hernia defect in the superior midline and right lower quadrant along with intraabdominal adhesions. Anesthesia: general endotracheal. Estimated blood loss: minimal. Drains: none. Complications: none. Specimen: none. Procedure: ¿after the patient was identified, she underwent general anesthesia and was sterilely prepped and draped in the usual fashion. The abdomen was entered bluntly under direct visualization with the laparoscope using a blunt-tipped trocar in the left mid abdomen. There were extensive adhesions of omentum and small intestine to the underside of the abdominal wall. There was a piece of gore-tex mesh covering the central portion of the abdomen from 6 or 7 cm above the umbilicus to 4 or 5 cm below. There was fibrotic peel on top of the mesh, and this was able to be peeled off, freeing most of the small bowel adhesions. There were omental adhesions to the underside of the fascia around the mesh, and these were lysed using blunt, sharp and harmonic scalpel dissection. There was a fascial defect in the upper midline, and this had omentum incarcerated in it. This was reduced by dividing adhesions using primarily harmonic scalpel dissection. The falciform ligament was divided and dissected out of the fascial defect as well. The margins of the defect were completely cleared and then a piece of 18 x 18 [sic] (b)(6) dualmesh was tacked to the underside of the fascia along the inferior and lateral aspects of the defect using prolene sutures. The tails of the sutures ware pulled out through stab wounds in the skin and tied in the subcutaneous space. The superior portion of the mesh was laid up over the liver where it was held in place with the protack device which was also used to tack the inferior portion to prevent gapping between the sutures. Attention was then turned to the right lower quadrant where there was a moderate-sized fascial defect from a previous incision. The peritoneum was taken off along the inferior aspect of the defect dissecting the right median umbilical ligament and bladder off of the underside of the fascia to expose cooper's ligament. A piece of 18 x 19 [sic] (b)(6) dualmesh was then tacked to the underside of the fascia using prolene with the tails of the suture pulled out through stab wounds in the skin and tied in the subcutaneous space. The inferior medial corner of the mesh was secured to (b)(6) ligament with the protack device, and the circumference of the mesh was tacked with the protack to prevent gapping between the sutures. The abdomen was then irrigated, aspirated and inspected for bleeding or injury and none was found. The ports were removed and the abdomen allowed to desufflate. The skin incisions at the laparoscopic port sites were closed with subcuticular vicryl and steri-strips, and the stab wounds where the sutures were placed on the corners of the mesh were closed with steri-strips. The patient tolerated the procedure well and was taken to the recovery area in stable condition. ¿ revision #2 preoperative complaints: [none provided], revision #2 procedure: laparoscopic lysis of adhesions. Laparoscopic incisional hernia, repair. [implant: physio mesh 15 x 20 [sic] oval], revision #2 date: (b)(6) 2010 [hospitalization dates unknown], wound classification: unknown. On (b)(6) 2010: (b)(6) system. (b)(6), md. Operative report. Anesthesia: general endotracheal. Estimated blood loss: minimal. Drains: none. Complications: none. Specimens: none. Procedure: ¿after the patient was identified, she underwent general anesthesia and was sterilely prepped and draped in the usual fashion. The abdomen was entered bluntly, under direct visualization with the laparoscope, using a blunt tip trocar in the left mid abdomen. The preperitoneal space was difficult to find. The left side of the abdomen was completely frozen. We turned our attention to the right side where we entered the abdomen again using a blunt tipped trocar under direct visualization with a laparoscope and we were able to encounter some free space. There were extensive intraabdominal adhesions that posed the risk of pain or small bowel obstruction and needed to be treated separately from the incisional hernia repair and an extensive laparoscopic lysis of adhesions was carried out to free the entire underside of the abdominal wall as a separate and distinct procedure from the incisional hernia repair. An additional 5 mm trocar was able to be placed in the left upper quadrant. I then carried out primarily sharp dissection lysing adhesions in the upper abdomen, which consisted of largely small bowel to the underside of mesh from previous hernia repair procedures. The adhesions were very dense, and the dissection was very difficult. We took great care to avoid injury to small intestine not to create enterotomy. After a lengthy tedious dissection, we were able to free a small area in the upper abdomen and begin work interiorly. There was a piece of mesh down the middle of the abdomen and another in the right lower quadrant. As we worked toward the periumbilical region, the adhesions were especially dense, and we were able to enter the fibrinous peel surrounding the mesh and peel this off leaving it on the surface of the bowel to help prevent additional dissection of the bowel over a small area. Unfortunately, by the edge of the mesh, the adhesions were very dense and leathery and difficult to get it free of the intestinal adherence. With great care and persistence, we were able to free down to the edge of the mesh and began working on the mesh in the right lower quadrant and with an hour of dissection we were able to free the underside of the abdominal wall. Attention was then turned to the hernia in the loft lower quadrant. This was repaired arthroscopically [sic] using a piece of 15 x 20 oval physio mesh with prolene sutures tacked around its circumference, and this was quite intra-abdominally and then the suture tails were pulled out through stab wounds and tied in the subcutaneous space to hold the mesh on the underside of the fascia. The absorbable tacker was used to tack the circumference of the mesh between the sutures to prevent gapping. The abdomen was then irrigated, aspirated and inspected for bleeding or injury and none was found. The surfaces of the small intestine that were previously dissected were especially carefully inspected, and no area of enterotomy were [sic] identified. The underside of the abdominal wall was then sprayed with evicel fibrin sealant to help with postoperative adhesion prevention. The surfaces of the intestines were also coated. This was allowed to dry. The ports were then removed and the abdomen allowed to desufflated [sic]. The laparoscopic port site incisions were closed with subcuticular vicryl and steri-strips. The stab wounds and suture site on the mesh were closed with steri-strips only. The patient tolerated the procedure well. And was taken to the recovery area in stable condition. ¿ explant preoperative complaints: on (b)(6) 2013: preoperative diagnosis: ¿small-bowel obstruction. ¿ explant procedure: robotic exploratory laparoscopy and lysis of adhesions. Laparotomy. Reduction of internal hernia. Debridement of skin, subcutaneous tissues, and muscle of left lower quadrant abdominal wall. Open repair of recurrent incisional hernia. Small bowel resection of terminal ileum and cecum colostomy. Removal of foreign body (mesh). Explant date: (b)(6), 2013 [hospitalization dates unknown] on (b)(6) 2013: (b)(6) hospital. (b)(6), md. Operative report. Assistant: (b)(6). Preoperative diagnosis: small-bowel obstruction. Postoperative diagnoses: small-bowel obstruction plus strangulated internal hernia, a recurrent left lower quadrant incisional hernia, extensive intraabdominal adhesions. Anesthesia: general endotracheal. Estimated blood loss: 250 cc. Drains: 10 mm flat closed suction. Complications: none. Specimen: products of debridement, culture and sensitivity, and terminal ileum and cecum. Procedure: ¿after the patient was identified, she underwent general anesthesia, was sterilely prepped and draped in usual fashion. The abdomen was entered bluntly under direct visualization with the laparoscope using a blunt-tipped trocar in the right upper quadrant. Additional 8. 5 mm robotic trocar was able to be placed in the lateral right mid abdomen and another in the left mid abdomen. The abdomen was explored and there were some adhesions of small bowel to the underside of the periumbilical region, and these were lysed from the underside of (b)(6) mesh, which had covered the entire underside of the midline from the epigastric region down to the pubic area. Numerous adhesions were lysed down into the suprapubic area where we were then able to identify loops of necrotic bowel. There was a recurrent incisional at hernia just to the left of the gore-tex mesh in the left lower quadrant, along the lateral border of the rectus muscle, but this was reducible and did not appear to be the source of strangulation. At this point we decided we would have to repair this hernia, so laparotomy was carried out, and the robotic instruments were removed. Transverse incision was made over the right lower quadrant hernia site. There was necrotic skin, subcutaneous tissue, and fascia identified and a thickened peritoneal hernia sac was debrided as well down to the fascial margins. The bowel was already reduced and there was no incarceration or strangulation here. We extended the fascial detect medially towards the midline, which exposed the gore-tex mesh, which was secured to the underside of the fascia with protack tacks. There was a necrotic bowel. We decided to remove the mesh, with the source of infection suture as this was removed with blunt, sharp, and cautery dissection. There were numerous fascial defects in the midline and these were unfortunately not going to be able to repair [sic] today. The abdomen was then further explored and there was a tight band of adhesion from omentum that was adherent to the mesh from the underside of the midline of the fascia and then it was adherent down to the base of the mesentery in the left lower quadrant. There was a loop of terminal ileum incarcerated under this band and it was necrotic. The band was lysed and we were able to reduce the internal hernia and inspected the bowel completely and the majority of the terminal ileum was not viable so we decided to resect this and this was done using an echelon 60 mm powered stapler to divide the ileum where it was viable and then the mesentery to the terminal ileum was divided with the same stapler with seamguard for hemostasis. The caput of the cecum was then resected to remove the terminal ileum and portion of the cecum from the operative field as specimen. A side-to-side anastomosis was then created using the same echelon stapler and the rent in the mesentery was closed with running silk suture. The patient was significantly septic and it was not clear that this would be a viable anastomosis, so it was decided to mature this as a double-barrel colostomy. This was done by opening a disk of skin in the right mid abdomen, and then creating a cruciate incision in the anterior rectus sheath. I then dilated in order to except [sic] the anastomosis which was then matured to the skin and secured to the fascia to prevent herniation. The abdomen was then irrigated with copious irrigation solution and the small intestines were inspected in a hand overhand fashion, and all of the remaining bowel was healthy and viable, with no injury. A 10 mm flat drain was placed through the left abdominal trocar site laid in the pelvis. The left lower quadrant hernia was then further debrided with additional necrotic skin, subcutaneous tissue, and fascia were removed using sharp and cautery dissection. The hernia was then repaired using #2 nylon retention sutures for full-thickness support and then a #1 looped nylon for the primary fascial repair. Skin was left open and packed with betadine-soaked gauze and dressed with a dry dressing. The remaining laparoscopic wounds were closed with subcuticular vicryl and steri-strips. The patient tolerated the procedure well, was taken to the recovery area in guarded condition. ¿ on (b)(6) 2013: (b)(6) services. (b)(6), md. Surgical pathology report. Specimen: debrided subcutaneous tissue. Mesh. Terminal ileum and cecum. Debrided necrotic abdominal tissue. Gross description: ¿the specimen is received in formalin labeled ¿debrided subcutaneous tissue¿. The specimen consists of multiple fragments. The first is green-dark gray necrotic fragment of tissue measuring 10 x 7 x 1. 9 cm. The underlying is locally hemorrhagic to yellow. The remaining fragments are focally hemorrhagic yellow to dark gray tissue with necrotic areas. These fragments measure up to 9. 6 cm in aggregate. These fragments are sectioned and representative sections are submitted into two cassettes called a. ¿ ¿the specimen is labeled ¿mesh¿. The specimen consists of an irregular sheet-like piece of red-tan material, consistent with mesh. This piece measures 27. 1 x 12 x 0. 3 cm. Throughout the piece there is metallic spring-like pieces and blue suture material. A small representative section is submitted into one cassette. The specimen is retained in the laboratory with the medical devices. ¿ ¿the specimen is received in formalin, labeled ¿terminal ileum and cecum¿. It consists of an approximately 37. 7 cm in length portion of terminal ileum, small bowel and cecum. The specimen ranges in diameter from 6. 6 to 0. 9 cm. The terminal ileum and small bowel are contorted in areas. There is an appendix grossly identified, measuring up to 6 cm in length and up to 0. 7 cm in diameter. The serosal surface of the specimen is red-brown and contains large necrotic green thin-walled areas measuring up to approximately 17. 5 cm. Opening the specimen reveals red fecal material. The mucosal surface is red-tan and contains multiple necrotic ischemic areas. In these areas, the mucosal surface is flattened and thin-walled. The mucosal surface in the cecum is red-tan. The ileocecal valve is hemorrhagic to tan. Located in the ileum, approximately 3 cm from the valve, is a constricted hemorrhagic brown area measuring up to 0. 9 cm. No mass lesions are grossly identified within the specimen. Along the serosal surface, there are multiple areas of adhesions. There is an area which is thickened and contains adhesions along with what appears to be synthetic mesh-like material. Sectioning through the mesenteric tissue reveals hemorrhagic cut surfaces with the vessels containing areas of blood clot. Multiple representative sections are submitted in fourteen cassettes as follows: c1 and c2 stapled margins, c3 cecum, c4 ileocecal valve, c5 and c6 constricted area in the ileum, c7 appendix, c8 through c12 random sections with c8 and c9 containing thin-walled areas, c10 random sections, c11 attached adhesions with synthetic-like material, c12 sections of bowel, c13 cross section of the vessels, c14 lymph nodes. ¿ ¿the specimen is received in formalin labeled ¿debrided necrotic abdominal tissue¿. The specimen consists of multiple fragments. The first is a strip-like elliptical red-tan skin measuring 34. 2 x 5 x 3 cm in depth. The surface of the skin is discolored red-tan. The subcutaneous tissue is focally hemorrhagic yellow with necrotic areas along the base of the fragment. Next in the container are multiple irregular green to tan-yellow necrotic fragments measuring up to 8. 9 cm in aggregate. The specimen is sectioned and representative sections of the skin are submitted in d1 and d2, remaining fragments d3. Representative sections are submitted in three cassettes called d. ¿ final diagnosis: ¿ ¿debrided subcutaneous tissue: fragments of acutely inflamed and partially necrotic soft tissue with vascular thrombosis. ¿ ¿mesh: portion of synthetic mesh. The remaining mesh is retained with the medical devices. ¿ ¿portion of terminal ileum and cecum: ischemic changes, extensive, large and small bowel with local gangrene. Extensive fibrous adhesions, vascular thrombosis and acute peritonitis. Resected margins are viable. Negative for atypia and malignancy. Benign appendix with fibrous adhesions. Benign pericolic lymph node. ¿ ¿debrided necrotic abdominal tissue: skin and soft tissue exhibiting extensive necrosis, acute inflammation and vascular thrombosis. ¿ relevant medical information: on (b)(6) 2013: (b)(6) hospital. (b)(6), md. Operative report. Assistant: karen andrews. Preoperative diagnosis: ileostomy and colostomy in the right lower quadrant with dehydration. Postoperative diagnosis: ileostomy and colostomy in the right lower quadrant with dehydration. Procedure: 1. Closure of ileostomy and colostomy in the right lower quadrant. 2. Debride skin and subcutaneous tissue using sharp dissection with a scalpel for approximately 20 g of tissue. Anesthesia: general endotracheal. Estimated blood loss: minimal. Drains: none. Complications: none. Specimen: products of debridement. - procedure: ¿after the patient was identified, she underwent general anesthesia, was sterilely prepped and draped in usual fashion. A sharp dissection was used to excise ileostomy and colostomy in the right lower quadrant where a previous ileocolectomy anastomosis had been matured as both ileostomy and colostomy. This was dissected free of the surrounding tissue down into the peritoneal space using blunt, sharp and cautery dissection. Anastomosis was inspected and it was found to be widely patent both ascending and descending directions and so the open end of it was stable off [sic] to close the ostomy and then the anastomosis was again palpated and found to be widely patent. This was irrigated and then returned to the peritoneal space where seprafilm was placed covering the new anastomosis and then the wound was closed with running pds on the posterior sheath running prolene on the anterior sheath and then the incision was again irrigated and the skin and subcutaneous tissues were debrided sharply to freshen the edges and remove the infected or otherwise injured tissue and then the wound was closed loosely with staples with telfa wound wicks in between the staples to allow for wound drainage. The patient tolerated the procedure well, and was taken to the recovery area in stable condition. ¿ on (b)(6) 2013: (b)(6) hospital. (b)(6), md. Operative report. Preoperative diagnosis: feculent wound drainage. Postoperative diagnosis: feculent wound drainage. Procedure: wound packing. Anesthesia: none due to neuropathy. Estimated blood loss: none. Complications: none. Specimen: none. Procedure: ¿after the patient was identified, she underwent a sterile preparation in usual fashion. The staples were removed from the right lower quadrant wound and the subcutaneous space was irrigated of feculent material, and the wound was packed open with gauze and dressed with a dry dressing. Stoma therapy nurses will come by to assess the wound later and apply a stoma bag. ¿ on (b)(6) 2013: (b)(6) hospital. (b)(6), md. Operative report. Assistant surgeon: (b)(6). Preoperative diagnosis: enterocutaneous fistula, right lower quadrant, status post ileostomy closure. Postoperative diagnosis: enterocutaneous fistula, right lower quadrant, status post ileostomy closure. Proposed procedure: exploratory laparotomy with takedown and closure of enterocutaneous fistula. Procedure done: exploratory laparotomy, extensive lysis of adhesions, takedown and closure of enterocutaneous fistula. Anesthesia: general endotracheal. Indication: ¿the indication for surgery in this (b)(6) female was the development of an enterocutaneous fistula approximately 4 to 5 weeks earlier after the patient had undergone closure of a temporary ileostomy. The patient had an extensive surgical history dating back to january of this year when she presented with a partial small bowel obstruction due to adhesions. She required urgent laparotomy in march of this year for a progressive abdominal pain associated with a bowel obstruction and the findings of a gangrenous loop of small bowel due to an internal hernia at that time. In addition to the laparotomy and small bowel resection, the continuity of the gi tract was restored using a side-to-side anastomosis between the distal ileum and ascending colon. This was matured as a double-barrel stoma in the right lower quadrant at that time due to the debilitated state at the time of surgery. The patient had survived that procedure and had gone on to have the ileostomy closed approximately 4 to 5 weeks earlier. Unfortunately following the closure, she developed an enterocutaneous fistula to the right lower quadrant abdominal wall. She had stabilized considerably after going on bowel rest and total parental nutritional support for approximately 3 weeks. It was felt that she was currently 4 months since her original laparotomy and for that reason, she was advised to proceed with a second surgery to close the enterocutaneous fistula for which she consented. ¿ procedure: ¿the patient was brought to the operating room, and after being identified was positioned on the or table in supine position. She underwent induction with general anesthesia and endotracheal intubation. Iv antibiotic prophylaxis was administered. A foley catheter was placed to decompress the urinary bladder. The anterior abdominal wall was then prepped and draped using betadine prep and sterile drapes to create a sterile field. An ioban sheet was placed to complete the draping process. Using the cautery an elliptical incision was then made around the enterocutaneous fistula in the right lower quadrant. The incision was designed to encompass all of the existing granulation tissue that had formed at the base of the fistula wound. The subcutaneous space was entered above the incision and carried down to the rectus fascia. The same technique was used to take down the fistula inferiorly with sharp mobilization down to the rectus. The rectus fascia was then divided around the circumference of the fistula tract and the peritoneal cavity was entered. It was necessary to proceed rather cautiously at this point due to numerous adhesions representing her previous surgery. We were able to define a plane just below the rectal column and this was developed around the circumference of the wound and fistula tract. Eventually, proceeding in the same manner, the ileal loops in the right lower quadrant were all fully defined and mobilized using careful blunt and sharp dissection. The regional omentum in the right upper quadrant was mobilized and preserved as well. 0 prolene suture material from the last laparotomy was identified and were encountered [sic] sharply removed. Eventually, the last 2 fees of ileum were fully mobilized down to the ileocolic anastomosis in the right lower quadrant. As expected, the fistula was found to originate from the anastomotic staple line. A dehiscence in the midportion of that staple line represented the etiology and origin of the enterocutaneous fistula. The anastomosis was then sharply mobilized and evaluated. It was felt to be intact. There was nothing about the anastomosis that would lend itself to suture line breakdown. It measured approximately 1. 5 fingerbreadths in size. We were concerned that perhaps this was too small and may have been the underlying cause for the fistula formation. Although her preoperative workup showed no evidence of a distal obstruction on the basis of a normal preoperative barium enema. With the dissection completed, the small bowel and anastomosis fully mobilized, the fistula was sharply excised and submitted as a surgical specimen. The common septum between the distal ileum and ascending colon was then extended for an additional 3 cm in length using an ethicon echelon 45 stapler with a vascular insert. The extension of anastomosis was reinforced above and below using a row of interrupted 2-0 silk (b)(6) sutures. The defect in the anastomosis was then closed by firing the tlc 60 stapler. The last staple line was oversewn with a 3-0 silk suture in a continuous fashion to fully imbricate and isolate the remaining staple line. The anastomosis was tested and found to be airtight at approximately 2. 5 fingerbreadths in width. At this point, with the anastomosis revised and the fistula closed, the anastomosis was returned to the right lower quadrant. The abdomen was irrigated out with copious amounts of antibiotic solution. A 10 mm (b)(6) drain was then placed in the right gutter and extended down into the pelvis. It was brought out through a stab wound then right upper quadrant. The initial sponge, needle, and instrument count was correct. The small bowel was covered with a sheet of seprafilm, draped with the regional omentum and a second sheet of seprafilm applied to the omental surface. The initial sponge, needle, and instrument count was correct at this time. The wound was then closed in layers using a #1 pds suture in an interrupted figure-of-eight fashion for the fascia. The subcutaneous space was irrigated out and scarpa fascia was reapproximated with interrupted 2-0 vicryl sutures. The skin was then reapproximated using surgical clips over quarter-inch penrose drain. The drain was secured with a 2-0 silk suture and a sterile dressing was applied to complete the procedure. All sponge, needle, and instrument counts for the case were correct on 3 counts. Estimated blood loss for the case was approximately 100 cc. The patient was hemodialysed. She received 1200 cc of crystalloid during the procedure. She was hemodynamically stable throughout the entire procedure and tolerated it well. She was returned to the recovery room, awake, extubated and in stable condition. On (b)(6) 2013: commonwealth health laboratory services. (b)(6) , md. Surgical pathology report. Specimen: fistula. Clinical diagnosis and history: ¿(b)(6) female with enterocutaneous fistula rlq [right lower quadrant] after small bowel resection now undergoes closure. Fistula submitted. ¿ pre-operative diagnosis: enterocutaneous fistula. Gross description: ¿the specimen is received in formalin, labeled ¿fistula'. It consists of three portions of tissue. First is a narrow ellipse of skin and underlying indurated somewhat hemorrhagic tissue. The skin measures 6. 2 cm in length x 1. 1 cm in width x 5. 2 cm in depth. The central skin surface has a linear longitudinal opening into the subcutis measuring about 5. 3 cm. A complete cross section is submitted in a1 and a2. The next irregular fragment of tissue measures 6. 5 x 3. 6 x 1. 8 cm and has apparent bowel mucosa seen on one side and adherent indurated fat. Sectioning through the bowel tissue reveals a staple line which may represent an anastomotic line, representatively submitted in a3. Lastly is an irregular fragment of rubbery red-brown to yellow tissue measuring 4. 5 x 2. 8 x 1. 8 cm, representatively submitted in a4. ¿ final diagnosis: ¿entero-cutaneous fistula: benign skin and small bowel with ulcer, extensive fat necrosis and inflammation consistent with an enterocutaneous fistula. Negative for malignancy. ¿ it should be noted that the gore® dualmesh® biomaterial instructions for use 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.
 
Event Description
It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2008 and (b)(6) 2009 whereby a gore® dualmesh® biomaterial device and two gore® dualmesh® biomaterial devices were implanted respectively. The complaint alleges that on (b)(6), 2009, (b)(6), 2010, (b)(6), 2013, (b)(6), 2013, (b)(6), 2013 and (b)(6), 2013 an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: mesh removal, recurrence, revision, dense adhesions, fistula, feculent wound drainage, ileostomy, colostomy, pain and suffering. Additional event specific information was not provided.
 
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Brand NameGORE® DUALMESH® BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key13285982
MDR Text Key287897253
Report Number3003910212-2022-01323
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/18/2022 Patient Sequence Number: 1
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