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| Model Number 1DLMC06 |
| Device Problem
Insufficient Information (3190)
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| Patient Problem
Unspecified Infection (1930)
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| Event Date 02/05/2009 |
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Event Type
Injury
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Manufacturer Narrative
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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.".
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Event Description
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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2008 whereby a gore® dualmesh® 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: infected mesh, explant.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) 2006: (b)(6) healthcare.(b)(6), md.Operative report.Operation performed: primary low transverse cesarean section, double layer uterine closure.(b)(6) 2007: (b)(6) healthcare.(b)(6), md.Operative report.Operation performed: repeat low transverse cesarean section, bilateral tubal ligation using filshie clips.Implant procedure: incisional hernia repair with 18 x 24 gore-tex dual mesh.Implant: gore dualmesh® biomaterial [1dlmc06/05116762, 18 x 24] implant date: (b)(6) 2008 (hospitalization (b)(6) ¿ (b)(6) 2008) (b)(6) 2008.(b)(6) healthcare.(b)(6) md.Operative report.Assistant: (b)(6) md resident.Preoperative diagnoses: 1) umbilical hernia.2) ovarian cyst.Postoperative diagnoses: 1) right ovarian cyst.2) incisional hernia.Anesthesia: general endotracheal intubation.Estimated blood loss: minimal.Informed consent: the risks, alternatives, and benefits of the surgery were discussed with the patient preoperatively and she is agreeable with proceeding.The risks include, but are not limited to, the risks of bleeding, infection and injury to surrounding structures.Description of procedure: ¿the patient was placed in a supine position and adequate anesthesia was induced.The area was prepped and draped in a sterile fashion.An incision was made in the midline through the previous incision at the level of the umbilicus.The subcutaneous tissue was divided using electrocautery and hemostasis was achieved as needed with same.The hernia sac was then dissected away from the base of the umbilicus.The fascia was identified and the hernia sac was entered.The rest of the midline incision was palpated and there multiple swiss cheese defects noted therefore the incision was extended superiorly and the fascia divided.The omental adhesions to the anterior abdominal wall were taken down with a combination of blunt and sharp dissection.Hemostasis was achieved as needed with electrocautery.The subcutaneous tissue was then dissected above the fascia to about 8 cm away from the fascial edge for placement of the mesh.The hernia sac at the umbilicus was amputated.An 18 x 24 gore-tex dual mesh was then cut to size and secured as an underlay mesh to the fascia using 0 prolene interrupted sutures.Once all the sutures were placed, they were tied and cut.The fascial edges were then reapproximated with 4 interrupted figure-of-eight 0 prolene sutures.Hemostasis was achieved.Two 7 mm flat jackson pratt drains were placed on either side of the incision and the base of the umbilicus was tacked to the fascia with a 2-0 vicryl suture.Subcutaneous tissue was reapproximated with 2-0 vicryl in running fashion and the skin was reapproximated with staples.The area was cleaned and sterile dressing was placed.A binder was placed in the recovery room.All sponge, needle and instrument counts were correct.¿ disposition: stable and awake in recovery room.Dictated by: (b)(6), md resident.(b)(6) 2008: (b)(6) healthcare.Implant sticker.Gore dualmesh® biomaterial.Ref catalogue number: 1dlmc06.Lot batch code: 05116762.W.L.Gore & associates.The records confirm a gore dualmesh® biomaterial (1dlmc06/05116762) was implanted during the procedure.Relevant medical information: (b)(6) 2008: (b)(6) healthcare.(b)(6) md.Operative report.Preoperative diagnoses: 1) large abdominal hernia.2) ovarian cyst with associated pain.Postoperative diagnoses: 1) large abdominal hernia.2) ovarian cyst with associated pain.Operation performed: repair of large umbilical hernia and right ovarian cyst aspiration.Description of procedure: ¿this patient was already in the operative suite under dr.Bay¿s care.At this time a laparotomy had been made and the peritoneum opened as well.The pelvis was thus exposed.On inspection of the pelvis, the left ovary appears to be within normal limits.There is no visible cyst or excrescences noted on the surface.As far as the right ovary is concerned this did contain and [sic] approximately 3 cm cyst that appears to be benign in nature.It is smooth.No excrescences are noted or papillation.Decision was thus made to go ahead and proceed to aspirate the right ovarian cyst.At this point, the 30 ml syringe was utilized with an 18-gauge needle and the cyst was aspirated.Approximately 25 ml of clearish yellow fluid was obtained, sent to pathology for cytology.The patient tolerated the procedure well and she was hemostatic.Please see the rest of dr.(b)(6) operative report for the preceding surgery.¿ explant procedure: removal of infected gore-tex mesh.Implantation of 6 x 12 alloderm graft.Explant date: (b)(6) 2009 (hospitalization (b)(6) 2009) (b)(6) 2009: (b)(6) healthcare.(b)(6) md.Operative report.Assistant: (b)(6) md resident.Preoperative diagnosis: infected mesh from prior umbilical herniorrhaphy.Postoperative diagnosis: infected mesh from prior umbilical herniorrhaphy.Anesthesia: general.Description of procedure: ¿the patient was brought to the operating suite and placed in the supine position.General anesthesia was induced with continuous cardiopulmonary monitoring.The abdomen was then prepped and draped in the usual sterile fashion.A vertical, skin incision was made along her prior incision in the periumbilical region.Electrocautery was used to control bleeding at the level of the skin.Dissected through subcutaneous tissue down to the level of the fascia.Upon division of the facia there were copious amounts of purulent material returned from above the prior gore-tex mesh.This was suctioned free of the wound, and the area was inspected.The gore-tex mesh was then removed by cutting the sutures and pulling this prior gore-tex underlay mesh out through the hole in the fascia.The area was reinspected, and there did not appear to be any injury to underlying bowel.The decision was then made to close the fascia and use the alloderm as an overlay mesh.Dissection was carried out over the top of the fascia to create room for the overlay alloderm mesh.The fascia was then closed using 0 prolene sutures in figure-of-8 fashion.After the fascia had been closed, the 6 x 12 cm alloderm mesh was implanted over the top of the fascia as an overlay repair.This was sutured in place using 0 prolene sutures in an interrupted fashion around the periphery of the mesh.Approximately 5 small incisions were made in the alloderm mesh prior to implantation to prevent formation of a fluid collection under the mesh and permit drainage through the planned jackson-pratt drain.After the mesh was secured in place, the area was inspected and appeared to have good repair.At this point, a #10 jackson-pratt drain was placed through a separate stab incision and brought into the cavity and laid on top of the alloderm graft.The area was inspected, and it was determined that the umbilical stalk was transected during the initial dissection.This was repaired with 2- layer closure of 2-0 vicryl internally and 4-0 subcuticular stitch externally.The subcutaneous tissues was then reapproximated over the top of the drain and mesh using 2-0 vicryl.The skin was closed with a running 4-0 vicryl subcuticular stitch.The patient tolerated the procedure well.There were no apparent complications.At the end of the case, all sponge, needle, and instrument counts were correct.Dr.(b)(6) was present throughout the entire procedure.¿ dictated by: (b)(6), md resident.Relevant medical information: (b)(6) 2009: (b)(6) healthcare.[signature illegible].Operative record/anesthesia.Asa 2-3.Height 5¿10, weight 109 kg [240 lbs.].(b)(6) 2009: (b)(6) healthcare.(b)(6) md.Preoperative & postoperative note/tissue slip.Preoperative diagnosis: infected abdominal wall mesh.Operation: removal infected mesh.Repair abdominal wall defect with alloderm graft.Specimen #a: infected mesh, culture and sensitivity.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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Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged.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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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® 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: ¿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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