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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: ¿ (b)(6) 2007: (b)(6) hospital.(b)(6), md.Indications: ¿mr.(b)(6) is a 53-year-old gentleman with symptomatic umbilical hernia who was being brought to the operating room for laparoscopic repair.¿ implant procedure: laparoscopic umbilical hernia repair.[implant: gore® dualmesh® plus biomaterial, 1dlmcp03/(b)(6), 10cm x 15cm x 1mm thick.] implant date: (b)(6), 2007 [hospitalization dates were not provided] ¿ (b)(6) 2007: (b)(6) hospital.(b)(6), md.Operative report.Preoperative diagnosis: umbilical hernia.Postoperative diagnosis: umbilical hernia.Anesthesia: general.Estimated blood loss: minimal.Specimens: none.Complications: none.¿ wound classification: ¿clean ¿ ¿ findings: ¿umbilical hernia.¿ ¿ procedure: ¿informed consent was obtained.The patient was taken to the operating room and placed in the supine position.After administration of general endotracheal anesthesia, the abdomen was prepped and draped in the usual sterile fashion.Next a 10 mm incision was made in the left subcostal margin and access to the peritoneal cavity was obtained with the opti-vu trocar.A pneumoperitoneum was obtained and then placed a 5 mm trocar in the left lower quadrant and the right upper quadrant.Next the hernia was visualized and a 10 x 15 cm piece of gore-tex dualmesh was obtained.Stay sutures were placed superiorly and inferiorly and the mesh was introduced into the abdomen.It was then unfurled and the gore-tex suture passer used to tack up the previously placed stay sutures exteriorly through the abdominal wall.The protack device was used to tack up the mesh circumferentially.Two additional sutures of gore-tex were placed on both lateral sides.Being satisfied, the 10 mm trocar was removed and the gore suture passer used to pass a vicryl suture through this.The pneumoperitoneum was allowed to egress.All trocars were removed and all skin incisions reapproximated with monocryl and sterile dressings applied.¿ ¿ (b)(6) 2007: (b)(6) hospital.Implant record.¿mesh dual plus 15cm x 19cm x 1mm thick.¿ site: abdomen.Catalog #: 1dlmcp04.Lot #: 05186130.Size: 10x15cm.Manufacturer: wl gore & associates.Relevant medical information: ¿ (b)(6) 2020: (b)(6) hospital.(b)(6)., md.Operative note.Procedure: robotic assist laparoscopic sleeve gastrectomy.Preoperative diagnosis: morbid obesity.Postoperative diagnosis: same.Anesthesia: general.Estimated blood loss: minimal.Specimen: portion of stomach.Complications: none.Indications: [not provided] wound classification: [not provided] procedure: ¿the patient was taken to the operating room [or] and placed in supine position.General anesthesia was administered via endotracheal intubation per anesthesia.The patient was secured with three sets of straps to the or table.Care was taken to assure that there was adequate cushioning and that there was no undue pressure with any of the straps.An oro-gastric tube was placed.The abdomen was prepped and draped in sterile fashion.Timeout was performed with all members of the team participating.A veress needle was inserted in the left upper quadrant and pneumoperitoneum was created.A small incision was made in the left mid abdomen and the abdomen was entered with an optical trocar using a 0° scope.General inspection was carried out followed by placement of additional trocars under direct vision.Adhesions were taken down as necessary to allow for this.The pylorus was identified and starting 5 cm proximal to this the greater curvature was freed up and posterior attachments were released.This continued all the way up to the esophageal hiatus.A visi g 40 french bougie was a position against the lesser curvature and division was then begun.This was started staying wire from the bougie followed, by becoming adjacent to the bougie as progressed towards esophageal hiatus.[sic] staple line was closely inspected [sic] was found to be well formed with no evidence of bleeding.This was then submerged under saline and insufflated with occlusion distally.There is no evidence of air leak.General inspection was carried out followed by retrieval and removal of the specimen.The larger trocar sites were then closed using transfasciall [sic] absorbable suture.Subcutaneous tissue was irrigated followed by closure of the skin using 4-0 monocryi and then skin glue.Patient was transported to the pacu in stable condition.¿ ¿ (b)(6) 2020: (b)(6) hospital lab.(b)(6), md.Pathology report.Specimen: ¿stomach, body, body of stomach¿ final diagnosis: ¿a.Stomach, body, partial gastrectomy: mild chronic gastritis, negative for intestinal metaplasia, negative for granuloma, negative for malignancy.Negative for h.Pylori like organisms.¿ clinical information: ¿morbid obesity.¿ gross description: ¿received in formalin labeled stomach.The specimen consists of a 20.0 cm in length with diameters varying from 3.0 cm to 5.0 cm tubular pink portion of stomach, closed along one edge by a line of staples.The serosa is focally disrupted and dull with adhesions.There is a scant amount of attached perigastric fat.Opening reveals a focal area of submucosal hemorrhage.The remaining mucosa is pink and unremarkable with semiprominent rugal folds.No discrete masses, lesions, polyps, perforations or areas of ulceration are identified.Representative sections including the submucosal hemorrhage are submitted in al-a2.¿ explant preoperative complaints: ¿ (b)(6) 2020: (b)(6) hospital.(b)(6) md.Preoperative diagnosis: perforation bowel.Explant procedure: exploratory laparotomy with resection of small bowel with primary anastomosis.Negative pressure wound dressing.Explant date: (b)(6), 2020 [hospitalization dates were not provided] ¿ (b)(6) 2020: (b)(6) hospital.(b)(6)md.Operative note.Assistant surgeon: (b)(6), md.Postoperative diagnosis: perforation bowel.Anesthesia: general.Estimated blood loss: less than 100 ml.Specimen: small bowel.Mesh from previous hernia repair.Complications: none.¿ wound classification: [not provided] ¿ findings: ¿succus material within the abdominal cavity and small bowel that was attached firmly to mesh at the previous umbilical hernia repair.Tacks were present within this.This appeared to be sustained consistent with his chronic exposure to the mesh.[sic] there is enteric fluid within the subcutaneous tissue on the patient¿s right side where the 12 mm trocar was present.Sleeve gastrectomy staple line was intact and well perfused, good color.No areas of abscess.Remainder of small bowel appeared unremarkable.¿ ¿ procedure: ¿patient was taken to the operating room and after general anesthesia timeout was performed and the abdomen is [sic] prepped and draped in sterile fashion.Midline incision was begun and peritoneal cavities were entered.Cultures were taken.This was extended down over the mesh and the mesh was then cut free.This was then detached from the small bowel and in this area there was a hole in the small bowel.12 mm trocar site was 2 cm to the patient's right of the mesh.Copious amounts irrigation was carried out followed by division of the small bowel proximal and distal to the injured small bowel.Approximately 12 inches of small bowel was removed.The mesentery was divided using ligasure device and then the [sic] this was oversewn as well.A side-to-side stapled linear anastomosis, functional end-to-end was created and this resulted in a [sic] appropriate size lumen.Staple line was oversewn and the mesentery was then closed using vicryl as well.Continue [sic] with copious amounts irrigation [sic] all quadrants were irrigated including interloop areas.This was repeated several times and the surgical team changed gloves with this.Subcutaneous tissue looked healthy although somewhat stained.The 12 mm trocar site was also open and connected to where the air seal trocar had previously been located thus evacuate [sic] and the succus fluid and this too was cultured.Irrigation was carried out and this too appeared to be healthy.There is [sic] a generous amount of omentum and this was used to drape over the small bowel separating from the midline incision.Midline incision was then closed with 0 pds in a small bite technique.Irrigation was carried out followed by placement of foam for wound vac [vacuum assisted closure] in both these areas and connected with a bridge.This was sealed and connected to suction with appropriate results.Patient was discussed with the critical care doctor and will go to the icu intubated.He [sic] was on a small dose of neo [sic] the operating room and anesthesia felt like this would be rapidly titrated off at the end of anesthesia.¿ ¿ (b)(6) 2020: (b)(6) hospital lab.(b)(6), md.Pathology report.O specimens: - a.¿abdomen, abdominal explanted mesh¿ - b.¿small intestine, ileum, small intestine¿ o final diagnosis: - a.¿abdominal explanted mesh: synthetic mesh, attached fibrofatty tissue with acute and chronic inflammation and foreign body type granulomas.¿ - b.¿small intestine: perforated small intestine with surrounding acute serositis, proximal and distal surgical margins are viable, no evidence of inflammatory bowel disease or neoplasm is identified.¿ o clinical information: ¿perforation bowel.¿ o gross description: - a.¿received in formalin labeled abdominal explanted mesh.The specimen consists of a 10.0 x 8.5 x 0.7 cm irregular flat rubbery pale-tan fatty synthetic fragment of tissue with multiple coiled silver metallic structures, which appears grossly consistent with mesh.Representative sections are submitted in a single cassette.¿ - b.¿received in formalin labeled small intestine.The specimen consists of a tortuous unoriented segment of bowel, closed on both ends by a line of staples, with a moderate amount of attached mesenteric fat, which is adherent upon itself, and is approximately 15.0 cm in length by 2.7 cm in average diameter.A 2.5 cm perforation is identified, and is situated 5.0 cm from the closest stapled margin.The serosa is gray and dull with adhesions and focal areas of fibrinous exudate.Opening reveals a tan-green unremarkable mucosa with no discrete masses, lesions or polyps identified.Representative sections are submitted as follows: b1-b2: stapled margins, b3: adherent small bowel, b4-b5: perforation.¿ relevant medical information: ¿ (b)(6) 2021: (b)(6) hospital lab.(b)(6), do.Cytology report.O specimen: ¿abdomen, abdominal abscess drainage¿ o final diagnosis: ¿abdomen, fine-needle aspiration (cell block and cytospin): extensive acute inflammation with portions or fibroadipose tissue.No malignant cells seen.¿ o gross description: ¿specimen labeled ¿abdomen.¿ received 18 ml of fresh, thick, red-brown fluid.One cytospin and one cell block submitted for evaluation.¿ the investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore® dualmesh® plus biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ 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, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.C1: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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