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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problem
Unspecified Infection (1930)
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| Event Date 01/02/2009 |
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Event Type
Injury
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Manufacturer Narrative
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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).It should be noted that the gore® dualmesh® plus 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® plus 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 open ventral hernia repair on (b)(6) 2007 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2009, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: additional surgery, adhesions, debridement, infection, pain, mesh removal.Additional event specific information was not provided.
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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: relevant medical information: ¿ (b)(6) 2007: memorial hospital of (b)(6).(b)(6), md.Anesthesia record.Weight: 209 lbs.No tobacco.Asa status 2.Implant procedure: repair of ventral hernia with composix gore mesh.Implant: gore® dualmesh® plus biomaterial.[1dlmcp04/ (b)(6), 15 x 19 cm].Implant date: (b)(6), 2007 (hospitalization (b)(6), 2007) ¿ (b)(6) 2007: memorial hospital of (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: ventral hernia.Postoperative diagnosis: ventral hernia.Procedure: ¿under general anesthesia administered by dr.(b)(6), the abdomen was prepped and draped in the usual fashion.A midline incision was made from the umbilicus to the pubis.Upon entering the peritoneal cavity, two hernia defects were noted, one at the upper portion of the incision and one at the lower portion of the incision.The adhesions to the intraabdominal wall were taken down and a 19 x 15 piece of gore dual mesh was placed intraperitoneally with the smooth sides down and then it was secured to the fascia at the superior and inferior aspect of the incision with surgilon sutures.It was then tacked laterally with surgilon followed by the stat tacker to circumferentially tack the mesh to the undersurface of the rectus muscle.The fascia was then closed over the mesh in the midline with figure-of-8 ethibond sutures to accomplish two layer closure.Subcutaneous tissue was closed with vicryl and the skin was closed with intracuticular monocryl and steri-strips.¿ ¿ (b)(6) 2007: memorial hospital of (b)(6).Implant sheet.Gore dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp04.Lot batch code: 05190125.Exp.Date: 2010-06.Site: ventral hernia.# implanted: 1.¿ (b)(6) 2007: memorial hospital of (b)(6).Perioperative record.Implant identification: description: mesh dual plus 15 cm x 19 cm.Manufacturer: gore.Catalog number: 1dlmcp04.Lot number: 05190125.Size: 15 cm x 19 cm.Expiration date: 06/30/10.Implant site: ventral hernia ¿ abdomen.Quantity: 1.Wound class: 1 ¿ clean.Surgeon comment: with mesh.¿ the records confirm a gore® dualmesh® plus biomaterial.[1dlmcp04/ (b)(6)] was implanted during the procedure.Relevant medical information: ¿ (b)(6) 2009: memorial hospital of (b)(6).Nurse notes.Scheduled procedure ¿ patient states: take out infected belly mesh.Hysterectomy in (b)(6).(b)(6) 2003 hernia repair with mesh with repeat due to infection.Breast reduction.Right breast biopsy on monday.¿ (b)(6) 2009: memorial hospital of (b)(6).Anesthesia record.(b)(6), md.Height: 5¿5, weight: 240 lbs.Pre-op diagnosis: infected abdominal mesh.Asa status: 3.Explant procedure: abdominal exploration, removal of infected mesh, ventral abdominal wall reconstruction with underlay alloderm placement.Explant date: (b)(6), 2009 (hospitalization (b)(6), 2008 ¿ (b)(6), 2009) ¿ (b)(6) 2009: memorial hospital of (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: infected ventral abdominal mesh, status post ventral hernia repair.Postoperative diagnosis: infected ventral abdominal mesh, status post ventral hernia repair.Anesthesiologist: (b)(6), md.Blood loss: 200 cc.Drain: one 19 blake in subcutaneous.Narrative: ¿with the patient under excellent general endotracheal anesthesia, she was positioned supine on the operating table with both arms out.She was prepped with chloroprep and draped in the usual sterile manner.A secondary incision was made excising the previous skin incision and a couple small areas of wound dehiscence.These were excised and the subcutaneous tissue was dissected.We found dense scar and very edematous tissues that were dissected down to where we identified some ethibond sutures clearly in the anterior abdominal fascia.We mobilized planes on the surface of the fascia circumferentially.Once these planes were well-demonstrated and we could see the ethibond sutures that had been passed through the mesh circumferentially we then divided the fascia in the midline and removed the sutures uncovering a large pocket filled with pus.Once this pus was aspirated free we were able to identify that there was a cavity in a retrofascial plane.We divided the fascia along the length of the incision and then with some blunt dissection we were able to free up the edges of the mesh which was pulled free en bloc.We did submit cultures from the purulent material and the mesh was treated as just a typical explant.Once the mesh was completely removed, we elected to obtain an alloderm.This was soaked for appropriate length of time.During the time the alloderm was soaking, we continued to clean up the fascial edges and debride the tissues as appropriate such that things were appropriately cleaned up and prepared for reconstruction.Once the mesh bad soaked for a sufficient period of time, we used the mesh to reconstruct the anterior abdominal wall with interrupted mattress style sutures going through the fascia, through the mesh, then back up through the fascia.We used approximately 20 sutures circumferentially such that there was good tension on the mesh such that there were no gaps between the sutures and they overlapped the edges of the midline appropriately.We did use a 16 x 6 piece of alloderm that was stretched and cut to appropriate length dividing approximately 1-2 cm in a superior to inferior plane.Once the underlay was completed and we were pleased with the situation of the mesh, we closed the fascia on the midline with double stranded running #i 1 pds, and then closed the skin with clips.A drain was brought through a stab incision into the subcutaneous tissue on top of the fascia.With counts completed and correct, we completed the procedure.Hemostasis was appropriate.She was transferred to the post anesthesia care unit in stable condition.Wound type is iv.¿ ¿ (b)(6) 2009: memorial hospital of (b)(6).Perioperative record.Explants: explant description: gore dual mesh plus.Manufacturer: gore.Model number: 1dlmcp04.Date of original: (b)(6) 2008.Serial number: (b)(6).Explant reason: infection.Disposition: to quality assurance manager.¿ (b)(6) 2009: memorial hospital of (b)(6).Implant sheet.Alloderm regenerative tissue matrix; size 6 x 16.Relevant medical information: ¿ (b)(6) 2009: memorial hospital of (b)(6).(b)(6), md.Discharge summary.Admit date: (b)(6) 2008.Discharge diagnoses: 1) infected ventral incisional hernia mesh.2) status post removal of infected mesh with abdominal wall reconstruction with ailoderm.3) acute renal failure likely secondary to nephrotoxicity from ketorolac versus vancomycin.4) history sleep apnea.5) hypothyroidism.6) status post hysterectomy.History of present illness: 38-year-old female who is status post repair of a large ventral midline hernia on november 3rd, who had complications, wound infection with debridement, been on oral antibiotic, without appreciable improvement.Came to the emergency department on (b)(6) with persistent pain and fevers and a white blood cell count 15,000.She was started on intravenous antibiotics and did not have appreciable improvement.Ct scan demonstrated that there was evidence of fluid collection posterior to the mesh.She was taken to the operating room on (b)(6) for exploration.There was found to be purulent material around the mesh.The mesh was removed and abdominal wall reconstructed with alloderm.Postoperatively, she did have anemia that was both secondary to chronic disease and blood loss.She was transfused 2 units of blood, had initially unremarkable recovery; however, her creatinine did increase markedly between the (b)(6).She was seen by nephrology and followed.A permanent catheter was placed and she underwent hemodialysis starting on (b)(6).She dialyzed essentially every other day from that point towards hospital dismissal, and arrangements were made for her to continue on hemodialysis as an outpatient.She made slow progress in terms of her recovery from a gi standpoint.Her appetite returned, and she began tolerating more oral diet and never had any appreciable nausea or vomiting postoperatively.Her anemia persisted once on hd, and she was treated with venofer to assist with progress and blood counts remained stable.Creatinine remained elevated, and it was decided to continue her on hemodialysis.She was dismissed to home, ambulating without assistance, tolerating regular diet with adequate pain control on oral medications.Follow up arrangements: return to see dr.(b)(6) in 2 weeks time for outpatient wound check and interval follow up.Continue dialysis, in fact, has appointment tomorrow for planned tuesday, thursday, saturday dialysis at (b)(6).Dismissal meds: vicodin, senna, aranesp, amlodipine, clonidine.Resume meds prior to admission included: synthroid, nexium, estrogen patch, cpap machine at night for obstructive sleep apnea.Dismissal care: monitor wound for any signs of infection including redness, swelling, discharge or fever.Should she note any changes, she should contact dr.(b)(6) immediately.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® plus 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® plus 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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H6: updated results code.Conclusion code remains unchanged it should be noted that the gore® dualmesh® plus 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® plus 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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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: ¿ 1/2/09: memorial hospital of south bend.Culture and sensitivity.Source: ¿fluid¿ ¿mesh removal/abdomen¿ ¿moderate staphylococcus aureus¿ 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® plus 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® plus 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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H6: updated health effect.H6: updated investigation finding.H6: updated type of investigation.H6: updated investigation conclusions.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® 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." 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.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 device.¿ 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.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 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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