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| Model Number |
1DLMC02 |
| Medical Device Problem Code |
Insufficient Device Problem Information (3190)
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| Health Effect - Clinical Code |
Unspecified Infection (1930)
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| Date of Event |
07/18/2006
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Type of Reportable Event
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Serious Injury
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Additional Manufacturer Narrative
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(b)(6).It should be noted that the instructions for gore® dualmesh® 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.¿ 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.¿.
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Event or Problem Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2006 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2006, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infected mesh requiring removal surgery.Additional event specific information was not provided.
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Additional Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged.
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Additional Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: on unknown date: [missing records: operative reports for roux-en-y bypass and laparoscopic ventral hernia repair were not provided.] on (b)(6) 2003: [missing records: records for ct scan showing ¿prosthetic mesh on anterior abdominal wall¿ were not provided.] on (b)(6) 2003: (b)(6) md.History and physical.History of present illness: presents with possible lower abdominal wall hernia.States approximately 1 month ago developed sudden onset abdominal pain located in periumbilical area.Exacerbated by movement and palpation.No masses felt; ct gave suggestion of periumbilical hernia.Underwent gastric partitioning and roux-en-y bypass 2 years ago by dr.(b)(6).Lost total 80 pounds since that (although regained approximately 20 of those).Developed ventral hernia one year ago repaired laparoscopically.Done well with that.Denies any symptoms of obstruction.States pains are on daily basis; 1-2 times day.Past history: history of hypothyroidism.Degenerative joint disease.Does not smoke.Examination abdomen: soft.Mild tenderness inferior and lateral (to the left) of umbilicus.I can detect no distinct hernia defects or masses.Ct scan demonstrates prosthetic mesh on anterior abdominal wall which is held in place by metal ¿screws¿.While there is no absolute defect, there is possible hernia defect along inferior edge of mesh, just superior to umbilicus.Impression: discussed all potential risks, complications, alternatives, and sequelae.Recommended consider observation for next several months to see if resolves itself, since cannot say by examination has hernia defect.Patient, however, insists upon having this fixed.Therefore, admitted for repair.On (b)(6) 2003: (b)(6) md.Operative report.Preoperative diagnosis: recurrent ventral hernia.Postoperative diagnosis: recurrent ventral hernia.Procedure: repair recurrent ventral hernia.Description of procedure: ¿the patient was placed on the operating table in the supine position and was induced with a general anesthetic and then prepped and draped in the usual sterile manner.A curvilinear incision was made around the umbilicus skirting it to the left.This was carried from approximately 1-2 inches inferior to the umbilicus to approximately 3-4 inches superior to the umbilicus.This was carried through the skin, subcutaneous tissue and down to the fascia.The fascia in turn was opened.The patient¿s mesh graft was identified and was carefully salvaged.The patient was found to have a small ventral hernia located on the inferior aspect of the graft/fascial closure.The fascia and peritoneum were opened and finger exploration of the rest of the abdominal wall demonstrated no other abnormalities.The fascial defect was then closed with figure-of-eight #1 prolene sutures.This was done without tension and did not require placement of further prosthetic mesh.With completion of this, the anterior fascia was closed with running #1 prolene suture.The subcutaneous tissue was closed with running 3-0 vicryl suture.During this, a subcutaneous lipoma was removed.The skin was closed with subcuticular 4-0 monocryl suture.All wound levels were infiltrated with 0.25% marcaine.The wound was cleansed and dressed, and the patient was discharged to the recovery room, having tolerated the procedure well.¿ on (b)(6) 2006: (b)(6).(b)(6), md.History and physical.Presents with recurrent ventral/incisional hernia.States noticed this approximately within last year.Claims to have pain and discomfort when straining or coughing.Denies symptoms of incarcerations, obstruction.Had cervical diskectomy [sic] approximately 6 months ago.Examination abdomen: soft, nontender.Has small hernia just beneath umbilicus.Readily reducible.Presents with recurrent abdominal wall hernia.Recommended this be repaired.Potential risks, complications, alternatives and sequelae have been reviewed.Patient understands and agrees to proposed procedure.On (b)(6) 2006: (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: recurrent ventral hernia.Postoperative diagnosis: recurrent ventral hernia.Title of procedure: repair of recurrent ventral hernia with composite mesh.Anesthesia: general.Description of procedure: ¿the patient was placed on the operating table in the supine position and was induced with general anesthetic.She was prepped and draped in the usual sterile manner.A curvilinear incision was made around the umbilicus overlying the hernia defect.This was carried through the skin and subcutaneous tissue and down onto the hernia sac.The limits of the sac were readily identified, exposing the fascial edges by sharp dissection and electrocautery.Some old suture material was removed during this.With completion of this, the entire edge of the sax [sic] was identified, as were the facial [sic] edges.The sac was not opened but merely passed back into the abdominal cavity.A composite gortex patch was then cut to the appropriate size.Using a running #1 prolene suture the patch was sutured to the fascia.This was done with a running simple stitch utilizing a sandwich technique (passing the gortex both above and below the fascia).With completion of this, all wounds were infiltrated with 0.25% marcaine.The subcutaneous tissue was closed with interrupted #3-0 vicryl sutures.The skin was closed with subcuticular #4-0 monocryl suture.The wound was cleansed and dressed and the patient was discharged to the recovery room having tolerated the procedure well.¿ on (b)(6) 2006 [assigned]: (b)(6).Intraoperative record.Implant sticker.Site: umbilical area.Gore® dualmesh® biomaterial.Ref catalogue number: (b)(4).Lot batch code: 04049830.W.L.Gore & associates.The records confirm a gore® dualmesh® biomaterial (1dlmc02/04049830) was implanted during the procedure.On (b)(6) 2006: [missing records: a culture report detailing analysis of specimens showing ¿normal skin flora, no evidence of other pathogen¿ was not provided.] on (b)(6) 2006: (b)(6).(b)(6), md.History and physical.Presents with infected prosthetic mesh following repair of recurrent ventral/incisional hernia.With regards to hernia, has had no recurrence, but has had persistent drainage from umbilical region.Because of inability to clear infection, admitted for removal of prosthetic mesh and closure with alloderm or primarily utilizing facial [sic] flaps.Examination abdomen: soft, nontender.Chronic draining area from umbilicus.Operative incision is well healed.No evidence of recurrence of hernia.Cultures have demonstrated patient to have normal skin flora.No evidence of any other pathogen.Has had multiple courses of antibiotics and persisting wound care.On (b)(6) /06: (b)(6).(b)(6) , md.Operative report.Preoperative diagnosis: infected gore-tex composite mesh ventral hernia graft.Postoperative diagnosis: infected gore-tex composite mesh ventral hernia graft.Procedure: excision of infected ventral hernia gore-tex mesh; placement of alloderm graft with closure of abdominal wall fascia/ventral hernia repair.Dictation: ¿the patient was placed on the operating table in a supine position.She was induced with a general anesthetic and then prepped and draped in the usual sterile manner.A dilute peroxide/methylene blue solution was injected into the sinus tract.This had an external opening at the deepest depths of the umbilicus.Following completion of this (used to mark the extent of the sinus itself) a curvilinear incision was made through the prior operative wound to the left of the umbilicus.This was carried through the skin and subcutaneous tissue down onto the anterior fascia.Using sharp dissection and electrocautery both for dissection and hemostasis the gore-tex composite mesh was removed en toto from the operative site.This was done circumferentially and done in such a fashion so as to include any and all tissue suggestive of infectious contamination (i.E.Stained blue).With completion of this the entire gore-tex composite mesh had been removed.The patient¿s previous marlex mesh located in the upper portion of the abdomen was exposed but demonstrated no evidence of contamination or infection.The hernia sac itself was opened and excised.This helped delineate the fascial edges.An alloderm, was placed intra-abdominally.This was transfixed with through and through sutures through the fascia and through the alloderm graft intraperitoneally.These sutures were placed as horizontal mattress type sutures and they were placed circumferentially around the graft.Great care was taken not to injure any of the underlying intraabdominal organs during this.With completion of this the fascial edges were closed transversely using #1 prolene sutures (as had been used on the alloderm transfixation).With completion of this closure the wound was infiltrated at all levels with 0.25% marcaine.The depths of the umbilicus, which had been amputated, were then closed in layers with 4-0 monocryl sutures.The skin was subsequently closed loosely with staples.No drain was placed.Sterile dressing was applied as well as an abdominal binder.The wound was cleansed and dressed and the patient was discharged to the recovery room having tolerated the procedure well.¿ on (b)(6) 2006 [assigned]: (b)(6).Intraoperative record.Implant sticker.Alloderm® regenerative tissue matrix.On (b)(6) 2006: (b)(6).(b)(6), md.Pathology report.Accession number: (b)(4).Clinical summary: infected ventral hernia patch.Microscopic diagnosis: infected ventral hernia gore-tex mesh (removal): granulation tissue with active chronic inflammation and fibrous tissue with foreign body, foreign body reaction with giant cells and fat necrosis.Gross description: the specimen is received in one part, in formalin, labeled with the patient¿s name and ¿infected tissue and mesh¿.The specimen consists of 2 tan portions of fibrofatty tissue measuring 3.0 by 2.8 by 0.8 cm and 5.5 by 4.5 by 2.2 cm, respectively.The larger fragment is sectioned revealing a central 4.5 cm cavity which contains a portion of synthetic yellow mesh material.Staples and suture material are also seen.The smaller fragment is sectioned revealing a fibrofatty cut surface.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® 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.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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Additional 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® 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 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.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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