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W.L. GORE & ASSOCIATES GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number GKFV1015 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Pain (1994); Seroma (2069); Bowel Perforation (2668); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/22/2018 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).It should be noted that the instructions for gore® synecor intraperitoneal biomaterial use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2018 whereby a gore® synecor intraperitoneal biomaterial was implanted.The complaint alleges that on (b)(6) 2018 an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: "on (b)(6) 2018, an exploratory laparotomy with explantation of previous hernia mesh and repair of small bowel perforation.At the time of this surgery, (b)(6) condition was noted to be critical.Further, (b)(6) was diagnosed with sepsis due to an unspecified organism." four days after her initial discharge, she returned "with severe postprandial abdominal pain, nausea and vomiting." additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.H6: results code 1.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: relevant medical information: [ni] [not indicated].Implant procedure: laparoscopic incarcerated incisional ventral hernia repair with an underlay reinforcement with a 15 x 10 cm synecor mesh.Laparoscopic wedge biopsy of the liver.Laparoscopic lysis of adhesions x30 minutes.Implant: gore® synecor intraperitoneal biomaterial [gkfv1015/16525072, 15 x 10 cm] implant date: (b)(6) 2018 (hospitalization [ni].(b)(6) 2018: (b)(6) center.(b)(6), md.Operative report.Preoperative diagnosis: chronic abdominal pain post roux-en-y gastric bypass.History of nonalcoholic steatohepatitis with recent history of alcohol abuse.Postoperative diagnosis: chronic abdominal pain post roux-en-y gastric bypass secondary to multiple intraabdominal adhesions and incarcerated incisional ventral hernia in the epigastrium.History of nonalcoholic steatohepatitis with recent history of alcohol abuse.Anesthesia: general endotracheal.Estimated blood loss: negligible.Drains: none.Specimens removed: wedge biopsy of liver.Complications: none.Background: this is a 48-year-old female with a prior history of morbid obesity status post roux-en-y gastric bypass with me, no longer morbidly obese, however, presented to the office with a recent history of alcohol abuse and epigastric pain and the patient, therefore, underwent upper gi endoscopy to rule out marginal ulcer and she was found to have normal anatomy without marginal ulceration.For persistence of the pain, the patient has, therefore, been consented for exploratory laparoscopy or diagnostic laparoscopy and also biopsy of the liver.Description of procedure: ¿after appropriate consent was obtained, the patient was given prophylactic antibiotics intravenously and 5000 units of heparin subcutaneously and taken to the operating room and placed supine on the operating table.Foot compression devices were placed on her feet and initiated and after appropriate general endotracheal anesthesia was accomplished the abdomen was prepped and draped in the standard sterile fashion.A scalpel was then used to incise the skin 5 mm in the midline below the umbilicus and a 5 mm optiview trocar with a 5 mm 0-degree scope was then used to enter the abdominal cavity under direct visualization.No intraabdominal contents were injured during entrance into the abdominal cavity.Additional 5 mm trocars were placed in the right lower quadrant, a 5 mm trocar was placed in the right lateral abdomen.Intraabdominal contents were inspected and there, the previous gastric bypass was inspected, as the transverse mesocolon was retracted anteriorly due to adhesions of the omentum to the anterior abdominal wall, exposure to the small intestine was readily available and the alimentary limb was seen in its retrocolic position and there were multiple adhesions of the small intestine itself, the presence of which could actually be causing her pain.Therefore, all adhesions to the small intestine itself were taken down as well as to the biliopancreatic limb and the transverse mesocolic area was inspected and there was no defect in that area and no internal herniation.The common channel was followed down to the ileocecal valve without pathology.This lysis of adhesions took approximately 30 minutes.Electrocautery was then used to take down the adhesions of the omentum to the anterior abdominal wall.In the epigastrium, a 1 cm defect was seen with incarcerated omentum within it and omentum was delivered back into the abdominal cavity.It was unclear whether this small hernia was part of the etiology of her pain.Therefore, it was elected to repair that hernia defect with an underlay reinforcement with the bio-a mesh.Therefore, a 15 x 10 cm bio-a oval synecor mesh was then rolled and introduced over the abdominal cavity and then tacked into position with securestrap absorbable tacking device both circumferentially and peripherally and within the midportion of the mesh.A wedge biopsy of the edge of the left lobe of liver just to the right of the falciform ligament was taken with the shears and hemostasis was accomplished with electrocautery.This specimen was removed.A 40 ml of 0.25 % was then used to inject around the area of the tacking of the mesh as well as the trocar sites and the abdomen was then desufflated of c02 and the 5 mm trocars were then removed and the skin incisions were then closed with 3-0 monocryl interrupted, then further reinforced with dermabond dressing and the patient was then awakened from.¿ [nurse reviewer note: incomplete record].Relevant medical information: [ni].Explant procedure: [ni].Explant date: [ni] (hospitalization [ni].Relevant medical information: [ni].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® synecor intraperitoneal 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.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2018: covenant health system.Implant sticker.Gore® synecor intraperitoneal biomaterial.Ref: (b)(4).Sn: (b)(6).Exp: 2020-06-27.Explant procedure: exploratory laparotomy with explantation of previous hernia mesh and repair of small bowel perforation.Explant date: (b)(6) 2018 (hospitalization [ni]).(b)(6) 2018: (b)(6), md.Operative report.Preoperative diagnosis: acute abdomen.Postoperative diagnosis: acute abdomen secondary to perforated small bowel.Procedure performed: exploratory laparotomy with explantation of previous hernia mesh and repair of small bowel perforation.Anesthesia: general endotracheal.Estimated blood loss: negligible.Drains: none.Specimens removed: hernia sac and necrotic edge of small bowel perforation.Complications: none.Anesthesia time: 7:19 p.M.To 8:52 p.M., 1 hour and 33 minutes.Surgical time: 7:35 p.M.To 8:37 p.M., 1 hour and 2 minutes.Background: this is a 48-year-old female with a prior history of morbid obesity, status post roux-en-y gastric bypass with me, who underwent laparoscopic lysis of adhesions and incisional ventral hernia repair 3 days previously.She experienced acute onset abdominal pain 24 hours ago and presented to the emergency room, was found to have an acute abdomen and has been consented for exploratory laparotomy.Description of procedure: ¿after appropriate consent was obtained, the patient was given prophylactic antibiotics intravenously and 5000 units of heparin subcutaneously, taken to the operating room, placed supine on the operating table.Foot compression devices were placed on her feet and initiated, and then after appropriate general endotracheal anesthesia was accomplished, the abdomen was prepped and draped in the standard sterile fashion.A scalpel was then used to excise the previous 10 cm upper midline scar and the subcutaneous tissues were then divided down to midline fascia.Midline fascia was then divided with electrocautery and a previously placed mesh was encountered.The incision was extended additional 5 cm inferiorly.The mesh was then detached off the anterior abdominal wall as it was secured just with absorbable securestrap tacking device at the previous surgery.There was a large amount of succus entericus, which was within the abdominal cavity and this was all suctioned out, and after copious amounts of irrigation, the area was inspected and there was an area of the alimentary limb, which was 40 cm proximal to the jejunojejunostomy, which was part of the area, which had undergone lysis of adhesions, which was found to have a perforation.The perforation was small and 2 mm in diameter.Metzenbaum scissors were used to cut out the area of the necrotic edges of the perforation until the edges of the enterotomy were healthy and the small enterotomy, which was now 5 mm in diameter, was then closed with a 3-0 pds in a running 2-layered lembert fashion.Further surveillance was accomplished of the entire abdominal cavity and no further pathology was encountered.This area of perforation was likely an area where previously the lysis of adhesions caused deserosalization of the area and with a postop ileus that area was thinned and then eventually ended up perforating.An additional 7 l of normal saline were used to irrigate out the abdominal cavity until clear effluent returned.The fascia was then closed with #1 pds in a running fashion.There was a necrotic fat in the subcutaneous space in the lower aspect of the incision heading to the left where the patient had previously noticed a bulge and this fat was debrided back until healthy fat was encountered.The upper incision, which had no necrotic fat, was partially closed with 2-0 nylon suture, vertical mattress, interrupted x3.The lower incision was then packed with normal saline wet-to-dry gauze dressing and sterile dressings were then applied and the patient was then awakened from anesthesia and taken to the recovery room in stable condition.¿ relevant medical information: (b)(6) 2018: (b)(6), md.Pathology report.Final diagnosis: small bowel resection: fragments of small bowel with mucosal erosion and acute and chronic serositis (clinically perforated).No evidence of malignancy.Specimen(s) received: small bowel perforation.Clinical history: perforated bowel.Gross description: specimen is received with patient name and dob.Specimen received in formalin and labeled small bowel perforation, consists of a tan to hemorrhagic tissue fragment that measures 1 x 1 x 0.8 cm.The fragment is bisected.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information. it should be noted that the gore® synecor intraperitoneal 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.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect h6: updated investigation finding h6: updated investigation conclusions h6: health effect impact code: f1903: device explantation h6: medical device component: g04088: membrane 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.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.It should be noted that the gore® dualmesh® plus biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further state: ¿improper positioning of the smooth, non-textured surface adjacent to fascia or subcutaneous tissue will result in minimal tissue attachment.Persistent seroma may result.¿ 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.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.Section c1: name: plus antimicrobial product coating manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 03324286 additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect h6: updated investigation finding h6: updated investigation conclusions h6: health effect impact code: f26: no health consequences or impact h6: medical device component: g04089: mesh /g04053: fiber /g04088: membrane 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.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.It should be noted that the gore® synecor intraperitoneal 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, adhesions and related harms, bowel obstruction, contamination, defect recurrence and related harms, dysphagia, erosion or extrusions and related harms, exposure or protrusions and related harms, fever, fistula, gerd recurrence, infection, irritation or inflammation, mesh migration, mesh shrinkage, pain, parathesis, seroma or hematoma and related harms, tissue ischemia, wound dehiscence and additional intervention including surgery.The instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ 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 persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.The instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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 and sterilization records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated investigation conclusions.H6: health effect impact code: f26: no health consequences or impact.H6: medical device component: g04089: mesh /g04053: fiber /g04088: membrane.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.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.It should be noted that the gore® synecor intraperitoneal 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, adhesions and related harms, bowel obstruction, contamination, defect recurrence and related harms, dysphagia, erosion or extrusions and related harms, exposure or protrusions and related harms, fever, fistula, gerd recurrence, infection, irritation or inflammation, mesh migration, mesh shrinkage, pain, parathesis, seroma or hematoma and related harms, tissue ischemia, wound dehiscence and additional intervention including surgery.The instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ 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 persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.The instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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 and sterilization records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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