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W. L. GORE & ASSOCIATES, INC. GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number GKFV1520 |
| Device Problem
Insufficient Information (3190)
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| Patient Problem
Unspecified Infection (1930)
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| Event Date 12/26/2018 |
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Event Type
Injury
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Manufacturer Narrative
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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." the gore® synecor intraperitoneal 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.".
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Event Description
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It was reported to gore that the patient underwent laparoscopic incisional 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: debridement, infection, wound vac, mesh removal.Additional event specific information was not provided.
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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: implant procedure: exploratory laparotomy.Lysis of adhesions x1.5 hour.Recurrent incisional hernia repair with mesh.Partial mesh explantation.Implant: gore® synecor® intraperitoneal biomaterial [gkfv1520/17431953, 15 x 20 cm].Implant date: (b)(6) 2018 (hospitalization [ni]).On (b)(6) 2018: [facility ni].(b)(6) , md; (b)(6) , md.Operative report.Indications for surgery: 52-year-old female status post multiple incisional hernia repairs with mesh in the past.No [sic] presenting with recurrence on right lower and left lower quadrant.Intermittent symptoms of obstruction.Preoperative diagnosis: recurrent incisional hernias.Postoperative diagnosis: same.Surgeon/operator: (b)(6).Assistant surgeon(s): (b)(6).Estimated blood loss: 20 cc.Drains: jp and right lower quadrant hernia sac, foley catheter.Anesthesia: general endotracheal tube.Complications: uncomplicated procedure.Findings: extensive intra-abdominal adhesions from previous hernia repairs, 2 recurrence of the incisional hernia, one in the right lower quadrant and one in the left lower quadrant.Operative report: ¿the patient was brought to the operating room transfer from stretcher to operating room table, general anesthesia using endotracheal tube was induced and hence on managed by the anesthesia team.Preoperative antibiotics were given, sequential compressive devices were applied to bilateral lower extremities, operative field was prepped and draped in the usual sterile fashion, and who timeout was performed everyone agree.The procedure was started by making a lower midline laparotomy through the previous incisional scar extending from infraumbilical to symphysis pubis.Once reaching the fascia level, the dissection was very difficult and tedious secondary to dense adhesions of the posterior aspect of the abdominal wall and mesh from previous hernia repairs.Extensive lysis of adhesion had to be done at this step of the procedure.Once the fascial edges were fully mobilized, evaluation of the anterior abdominal wall was performed.At the previous pfannenstiel incision, where a previous repair with mesh was performed, the lateral edges appeared to have had recurrences of the incisional hernia.The right lower quadrant hernia was somewhat bigger than the left, the right lower quadrant contains cecum and part of small bowel.The left lower quadrant only had small bowel in it.Once the hernia content was fully mobilized and allowed to retract into the peritoneal cavity, inlets to the hernia was obliterated and a # 10 round jp was left in the cavity without stripping the hernia sac.The hernia defect at the left lower quadrant was closed once a content was allowed to retract back into the peritoneal cavity using 2-0 ethibond stitches interrupted.Partial explantation of the polypropylene mesh that was used for the old repair was then performed to achieve smooth edges of the fascia for our future reapproximation.A mesh was then brought on the field time gore sinecore [sic] biomaterial 10x20 cm oval mesh.It was anchored in place inferiorly and laterally using trans-fascial stitches of 2-0 ethibond.Additional security was done by utilizing ethicon secure strap stapling device to anchor the mesh to the anterior abdominal wall.This was done circumferentially.Additional 2-0 ethibond stitches were placed in the upper part of the mesh to the anterior abdominal wall.Once the entire area was covered with the mesh in a sub-lay fashion, the fascia was closed on top of that using a combination of looped 0 pds in the inferior aspect has 2-0 vicryl in the superior aspect.Both sutures were met anchored to each other.2-0 ethibond was then used to reinforce this fascial repair.Dermal layer was approximated using 3-0 vicryl.Skin was closed using staples.Abdomen was cleaned with alcohol and dried and dressing consisting of gauze and tegaderm was applied.Needle sponge instrument count and the procedure reported as correct.Dr.(b)(6) was prepped and present for the entire procedure.Patient was extubated and brought to the post anesthesia care unit in good and stable condition.¿ tissues/specimens removed or altered: none.Prosthetic devices, grafts, tissues, transplants or devices implanted if any: gore sinecor [sic] mesh 15 x 20 cm.On (b)(6) 2018: [facility ni].Implant record.Mesh synecor oval 15 x 20 cm.Manufacturer: w.L.Gore and associates.Size: 15cm x 20 cm.Implant site: incisional hernia.Lot number: 17431953.Catalog number: gkfv1520.Quantity: 1.The records confirm a gore® synecor® intraperitoneal biomaterial (gkfv1520/17431953) was implanted during the procedure.Explant procedure: abdominal wound exploration, wash-out, debridement.Partial mesh explantation.Explant date: (b)(6) , 2018 (hospitalization [ni]).On (b)(6) 2018: [facility ni].(b)(6) , md.Operative report.Surgeon: (b)(6) , md.Assistant: (b)(6) , md.Anesthesia: general endotracheal tube.Preoperative diagnosis: hernia mesh infection.Postoperative diagnosis: hernia mesh infection.Estimated blood loss: 10 cc.Complications: none.Indications for surgery: miss carlson is a 52-year-old female who has had multiple hernia repairs in the past, most recently in march, at which point synecor mesh was utilized.Since the [sic] she has developed a wound infection that required wound v.A.C.Therapy for a while.It appeared to have been successful initially, however, then she had a recurrence with draining sinus at the inferior aspect of her wound.This has persisted for a number of months now so she presented electively for a wound exploration, partial mesh explantation.Preoperative informed consent was obtained and all questions answered to her satisfaction preoperatively.Findings: infected synecor hernia mesh.Explantation of all grossly infected mesh.Specimen: hernia mesh.Operative summary: ¿the patient was brought to the operating room and transferred from the stretcher to the operating table.General anesthesia using endotracheal tube was induced and hence managed by the anesthesia team.Sequential compression devices were applied and the operative field was prepped and draped in the usual sterile fashion.Who time-out was performed and everyone agreed.The procedure was started by probing the two sinus tracts at the inferior aspect of the wound.These were found to be connecting.These tracts were then unroofed using electrocautery and a cavity was appreciated in the suprafascial plan.This cavity was opened up using a combination of blunt dissection as well as electrocautery at which point the synecor mesh was exposed and part of it was found to be incorporated, other parts of it were free-floating and viscus-infected fluid.All of the unincorporated parts were then debrided using a combination of sharp dissection as well as electrocautery and fluid was suctioned out, diluted and cleaned up to the best of our abilities.A total surface area of ______ cm [sic] was taken out.A few ethibond sutures were also encountered during this.These were all removed to the best of our abilities.The wound was then irrigated and dried and packing tape was left in place.The wound was left open with gauze over that.Sponge, needle and instrument counts at the end of the procedure were correct.Dr.(b)(6) was scrubbed and present for the entire procedure.Patient was extubated, brought to post-anesthesia care unit in good stable condition.¿ on (b)(6) 2018: [facility ni].(b)(6) , md; (b)(6) , md.Operative note.Indication for surgery: s/p incisional hr c mesh 3/18, complicated by post op wound infection, treated with vac therapy, now with persistent draining sinus.Preoperative diagnosis: infected hernia mesh.Postoperative diagnosis: same.Description of procedure: wound exploration, wash out, debridement.Partial mesh explantation.Surgeon/operator: (b)(6).Assistant surgeon(s): (b)(6).Estimated blood loss: 10 cc.Drains: packing.Anesthesia: general.Complications: none.Findings: infected wound and mesh, removal of 5x5cm mesh.Tissues/specimens removed or altered: other-infected abdominal wall mesh.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." the gore® synecor intraperitoneal 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.".
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Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged.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.The gore® synecor® intraperitoneal 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.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: partial explant procedure: abdominal wound exploration, wash-out, debridement.Partial mesh explantation.Partial explant date: (b)(6) 2018 [hospitalization dates unknown].(b)(6) 2018: facility not provided.Md not provided.Wound tissue culture.Procedure: ¿culture wound deep.Source: abdomen.Final report: moderate staphylococcus aureus.Direct smear: few polymorphonuclear leukocytes seen.¿ (b)(6) 2018: facility not provided.Elizabeth rinehart, md.Pathology results.Final diagnosis: ¿soft tissue and mesh, removal/excision: fragments of dense fibroconnective tissue with extensive acute and chronic inflammation, granulation tissue formation, and polarizable foreign material, consistent with mesh; negative for malignancy.Specimen: mesh, excision.¿ macroscopic description: ¿submitted in formalin are multiple fragments of mesh material and adherent soft tissue with an aggregate measurement of 6.2 x 4.5 x 0.3 cm.Representative sections are submitted in one cassette.¿ 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.The gore® synecor® intraperitoneal 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.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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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.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.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, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, pain, exposure (extrusion), bowel obstruction and recurrence.As with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia recurrence.¿ the instructions for use further warn: ¿strict aseptic techniques should be followed.When operative infection is suspected, dissection of involved tissues should be considered.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ the instructions for use further state: ¿for best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ 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.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 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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