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| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Fistula (1862); Unspecified Infection (1930); Obstruction/Occlusion (2422)
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| Event Date 05/15/1997 |
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Event Type
Injury
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Manufacturer Narrative
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Product identification records for the alleged gore device were not provided.Therefore, a review of the manufacturing records could not be performed.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 ventral incisional hernia repair on (b)(6) , 1997, (b)(6) , 2001 and (b)(6) , 2003 whereby multiple gore-tex® soft tissue patch devices were implanted.The complaint alleges that on (b)(6) , 1997, (b)(6) , 2001, and (b)(6) , 2003, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: dense adhesions, multiple bowel obstruction, recurrences, mesh infections, fistulas, abscesses, seromas, mesh removals, pain and suffering.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: implant procedure #1: incisional herniorrhaphy with gore-tex micromesh graft.Implant: gore® mycromesh® biomaterial [20 x 15 cm] [as per indicated in the operative report notes; no product identification records for available for review] implant date: (b)(6) 1997 (hospitalization unknown) (b)(6) 1997: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnosis: large incisional hernia.Postoperative diagnosis: same.Assistant(s): (b)(6) md.Findings: the patient had undergone a previous incisional herniorrhaphy using an apparent prolene mesh.The patient had developed a large ventral hernia to the right of the mesh, encompassing the entire right lower abdomen with considerable weakness of the surrounding fascia.Description of the procedure: ¿under satisfactory general anesthesia in the supine position, the abdomen was prepped and draped for surgery.A midline scar was excised and this incision later extended superiorly from the upper abdomen to near the pubis.This incision was carried down to the hernia which encompassed the right lower abdomen and was adjacent to the previous prosthetic graft.The hernia sac was dissected free of the surrounding tissue¿s complete circumference and a portion of the sac then excised and sent to pathology.The fascia surrounding the hernia was of relatively poor quality and some of this was also excised to gain access to better tissue.The peritoneum was partially approximated with a running suture of 3-0 pds.A micromesh graft, 20 x 15 centimeters, was then placed into the wound and approximated to the surrounding fascia using 0 prolene interrupted sutures, placed approximately 1 centimeter apart the full circumference of the fascial defect.With this accomplished, the wound was thoroughly irrigated with saline.A 5/8 inch penrose drain was brought out the inferior aspect of the wound from the most superior aspect of the wound.The subcutaneous tissues were approximated with interrupted 3-0 pds and the skin was approximated with skin staples.A sterile dressing was applied to the wound.The sponge count was reported as correct.Estimated blood loss was approximately 200 to 250 cc.The patient was sent to the recovery area in stable and satisfactory condition.¿ product identification records for the alleged gore device were not provided.Relevant medical information: (b)(6) 1997: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnosis: abscess of wound.Postoperative diagnosis: same.Procedure(s): improvement of drainage, wound abscess.Anesthesia: (b)(6) md.Findings: the patient has undergone a prior incisional herniorrhaphy which approximately three weeks following the operation suddenly drained purulent material.Since that time, the wound had periodically quit draining.The patient was brought to surgery today to improve the drainage in hopes of controlling the infection.The drainage interestingly is not malodorous and is rather mucoid in appearance.The patient¿s white blood count is normal with no left shift.Description of the procedure: ¿under satisfactory general anesthesia, with the patient in the supine position, the abdomen was prepped and draped for surgery.A drainage site at the inferior aspect of the midline abdominal wound was incised and enlarged.Aerobic and anaerobic cultures of the fluid were obtained.A second incision was made in the midline incision, well above the umbilicus and the subcutaneous fluid-filled cavity found to extend to this point.Penrose drains were then placed into the cavity from both the superior and inferior wounds and a large t-tube with many holes cut in it then ran the full length of the cavity from the superior wound.All drains were sutured in place with 2-0 silk sutures, the plan being to irrigate the wound through the t-tube containing many holes and the penrose drain serving to keep the skin incisions opened.The patient tolerated the procedure well.The sponge count was reported as correct.Estimated blood loss was less than 25 cc.The patient was sent to the recovery area in stable and satisfactory condition.¿ explant procedure #1: removal of gore-tex micromesh graft.Explant date: (b)(6) 1997 (hospitalization unknown).(b)(6) 1997: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnosis: infected gore-tex graft.Postoperative diagnosis: same.Anesthesia: general endotracheal anesthesia by dr.(b)(6) findings: the patient was found to have purulent appearing fluid which was cultured for both aerobic and anaerobic, lying over a gore-tex graft which was sutured in place with prolene sutures.Description of operation: ¿under satisfactory general anesthesia with the patient in the supine position, the abdomen was prepped and draped for surgery.A midline scar was excised from well above the umbilicus to below the umbilicus and this incision carried down to the pocket of fluid overlying the gore-tex micromesh graft.This fluid was cultured for both aerobic and anaerobic and aspirated.With this accomplished, the prolene sutures were sharply divided and the graft had been completely freed and removed.With this accomplished, the wound was irrigated with copious amounts of saline.The fascia and marlex graft from a previous hernia repair were approximated with interrupted #0 prolene sutures and the wound packed with betadine soaked gauze dressings with overlying dry dressing.The patient tolerated the procedure well.The sponge count was reported as correct.The estimated blood loss in the course of the procedure was less than 50 cc.The patient was seen to the recovery room in stable and satisfactory condition.¿ relevant medical information: (b)(6) 1997: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnosis: midline granulating wound of the abdomen.Postoperative diagnosis: same.Procedure(s) performed: primary closure of granulating wound.Anesthesiologist: general anesthesia by (b)(6) m.D.Description of procedure: ¿under satisfactory general anesthesia with the patient in the supine position, the abdomen was prepped and draped for surgery.The granulating wound was thoroughly irrigated with saline and using 3-0 nylon vertical mattress sutures, the skin and subcutaneous tissues were approximated.Sterile dressing was applied to the wound.The sponge count was reported as correct.The estimated blood loss was minimal.The patient was sent to the recovery room in stable and satisfactory condition.¿ (b)(6) 1998: (b)(6) hospital.(b)(6) md.Operative report.Procedure: massive incisional herniorrhaphy using prolene mesh.Assistant: dr.(b)(6).Preoperative diagnosis: massive incisional hernia.Postoperative diagnosis: massive incisional hernia.Findings: the patient had undergone a prior incisional herniorraphy approximately 1 ½ years ago using a gore-tex micro mesh graft, which became infected requiring removal of the graft.The patient, since that time, had gained weight and developed a massive hernia approximately 12 in x 12 in extending from just inferior to the costal margin to just superior to the pubis.Description of procedure: ¿under satisfactory general anesthesia with the patient is supine position, the abdomen was prepped and draped for surgery.A midline scar was excised from just below the xiphoid to the pubis and this incision carried down to the hernia sac, which was dissected free of the overlying adipose tissue and scar tissue to the level of the fascia the full circumference of the defect, which was approximately 12 in x 12 in.The fascia was then dissected free of the adipose tissue for a 2-3 cm distance from the fascial edge again the full circumference of the defect.The prolene mesh graft was then tailored to the dimensions of the defect and approximated with #0 pds sutures through the fascia the full circumference of the hernia defect with the pds sutures being placed approximately 1 cm apart.With this accomplished, the wound was irrigated with copious amounts of saline until the aspirate returned clear.A 5/8¿ penrose drain was brought out the inferior aspect of the wound and sutured in place with 3-0 nylon sutures.The subcutaneous tissues were approximated over the drain with interrupted 3-0 pds, and the skin was approximated with skin staples.A sterile dressing was applied to the wound.The sponge count was reported as correct.The estimated blood loss in the course of the procedure was less than 300 cc.The patient was sent to the recovery area in stable and satisfactory condition.¿ ¿ (b)(6) 1999: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnosis: recurrent ventral incisional hernia.Postoperative diagnosis: same.Procedure performed: open repair of recurrent ventral incisional hernia.Estimated blood loss: 100 cc.Anesthesia: by general endotracheal intubation.Description of procedure: ¿on the date of the procedure, (b)(6) 1999, the patient was brought to the operating suite where she was placed on the operating table in the supine position.Following establishment of general anesthesia, the patient¿s abdomen was prepped and draped in the usual sterile fashion using betadine paint.Initially, a right transverse incision was made over the region of the recurrent hernia.This incision was taken to the subcutaneous tissue by sharp dissection.Hemostasis was achieved with bovie electrocoagulation.The area of the hernia sac was identified.This was dissected free from the subcutaneous tissue.The sac was then opened and the peritoneal cavity was then entered.Small bowel was noted to be within this hernia sac.This was reduced to the peritoneal cavity.The sac was dissected free from the surrounding fascial edges.The hernia appeared to be related to a separation of previously placed mesh from the abdominal wall fascia.Repair was then accomplished by reapproximating this mesh to the lateral rectus fascia with interrupted #1 ethibond sutures.With the hernia repaired, the wound was closed.This was accomplished by reapproximating the deep subcutaneous tissue with interrupted 2-0 vicryl sutures.The skin edges were reapproximated with staples.A dressing of 4 x 4 gauze was placed.The patient was then awakened and returned to the recovery room in satisfactory condition.She appeared to have tolerated the procedure well.¿.
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Manufacturer Narrative
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B3/4/5/6: updated event or problem d1/2a/2b: updated brand name/ product code g3/4: updated pma/510(k) number 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.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.The alleged ¿two millimeter gore-tex soft tissue patch (dual-mesh)¿ mesh is being captured as gore-tex® soft tissue patch for product surveillance purposes.It should be noted that the gore-tex® soft tissue patch 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.After multiple requests, product identification information was not provided for this device and thus it could not be confirmed to be a gore hernia device.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.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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Event Description
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Implant #1 procedure: incisional herniorrhaphy with gore-tex micromesh graft.[implant: gore® mycromesh® biomaterial, 20 x 15 cm] [as per indicated in the operative report notes; no product identification records were available for review] implant #1 date: (b)(6) 1997 (hospitalization dates unknown).Explant #1 procedure: removal of gore-tex micromesh graft.Explant #1 date: (b)(6) 1997 (hospitalization dates unknown).Implant #2 procedure: exploratory laparotomy with removal of infected abdominal wall mesh, lysis of adhesions, small bowel resection, and repair of recurrent ventral incisional hernia with gore-tex dual mesh.[implant: gore-tex® soft tissue patch [as per indicated in the operative report notes; no product identification records for available for review].Implant #2 date: (b)(6) 2001 (hospitalization dates unknown).Explant #2 procedure: exploratory laparotomy with removal of infected gore-tex soft tissue patch.Extensive lysis of adhesions.Repair of enterocutaneous fistula.Explant #2 date: (b)(6) 2001 (hospitalization dates unknown).Implant #3 procedure: exploratory with extensive lysis of adhesions.Repair of ventral hernia with gore-tex soft tissue patch.[implant: gore-tex® soft tissue patch 2mm thick, [as per indicated in the operative report notes; no product identification records for available for review].Implant #3 date: (b)(6) 2003 (hospitalization dates unknown).Explant #3 procedure: exploratory laparotomy and removal of infected gore-tex mesh; lysis of adhesions; repair of recurrent ventral hernia with surgi-assist mesh.Explant #3 date: (b)(6) 2003 (hospitalization dates unknown).
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Search Alerts/Recalls
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