|
|
| Model Number 1310015020 |
| Device Problem
Insufficient Information (3190)
|
| Patient Problems
Abscess (1690); Unspecified Infection (1930)
|
| Event Date 12/21/2012 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
It should be noted that the gore-tex® soft tissue patch 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-tex® soft tissue patch 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.".
|
| |
|
Event Description
|
|
It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2003 whereby a gore-tex® soft tissue patch was implanted.The complaint alleges that on (b)(6) 2012, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: abscess, infection, and explant.Removal due to large infection, abscess, fluid collection.Additional event specific information was not provided.
|
| |
|
Manufacturer Narrative
|
|
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: incisional hernia repair with gore-tex graft.Implant: gore-tex® soft-tissue patch [1310015020/00955375, 10 x 15 cm].Implant date: (b)(6) 2003 (hospitalization [ni]).On (b)(6) 2003: (b)(6) medical center.(b)(6) , md.Operative report.Preoperative diagnosis: incisional hernia.Postoperative diagnosis: incarcerated incisional hernia.Anesthesia: general endotracheal anesthesia.Findings: a large incisional midline hernia with multiple finer-like projections and incarceration of small bowel and omentum.A large hernia sac that had to be reduced.A 10 x 15 cm portion of gore-tex graft was utilized to repair the incisional hernia.Steps in procedure: ¿the patient was placed in the supine position and after a sufficient level of general anesthesia was obtained the abdomen was prepped and draped in normal sterile fashion.A longitudinal midline incision was made and carried down carefully through skin and subcutaneous tissue.The findings were of a huge midline defect with multiple incarcerated portions of hernia sacs, omentum and small bowel.This was carefully taken down and reduced.The hernia sac was excised as much as possible.Portions were submitted to pathology for permanent sectioning.After clearing out an adequate portion of fascia a 10 x 15 cm x 2 mm gore-tex graft was sutured in place using running 0 prolene.This gave good closure without tension.The wound was irrigated copiously with ancef solution and the incision was closed in layers using 3-0 dexon interrupted simple suture for the subcutaneous tissue.The skin was reapproximated using skin staples.A sterile dressing was placed and she was extubated and awakened and taken from the operating room to the recovery room in good condition.On (b)(6) 2003: (b)(6) medical center.Implant sticker.Gore-tex soft tissue patch.Item #: 1310015020.Lot #: 00955375.The records confirm a gore-tex® soft-tissue patch (1310015020/00955375) was implanted during the procedure.Relevant medical information: on (b)(6) 2012: (b)(6) healthcare.Lab.Wbc 11.8 h (4.0-10.5).On (b)(6) 2012: (b)(6) healthcare.Microbiology.Fluid culture: specimen: abdomen.No growth day 4.Gram stain-fluid: numerous mononuclear white blood cells.Rare polymorphonuclear white blood cells.No organisms seen.Anaerobe culture: prevotella oralis group.Tissierella praeacuta.Explant procedure: exploratory laparotomy.Incision and drainage of abdominal abscess.Removal of infected gore-tex mesh.Explant date: (b)(6) 2012 (hospitalization (b)(6) 2012).On (b)(6) 2012: (b)(6) medical center.(b)(6) , md.Operative report.Preoperative diagnosis: abdominal wall abscess.Postoperative diagnosis: abdominal wall abscess.Infected gore-tex mesh.Intraabdominal abscess.Intrabdominal phlegmon.Ventral hernia.Assistant: henry todd, md, resident.Anesthesia: general endotracheal.Indications for procedure: this is a 53-year-old female with a history of ventral hernia repair with gore-tex mesh now presenting with abdominal pain and erythema.Ct scan demonstrated a large abdominal wall fluid collection around the mesh.Purulent aspiration confirmed the diagnosis of mesh infection.Description of procedure: ¿the patient was consented for the procedure after history and physical were reviewed and patient and procedure were verified in the preoperative holding room.She was taken to the operating room, placed on the operating table in supine position.After successful initiation of general endotracheal anesthesia, she was prepped and draped in sterile fashion.Timeout was preformed to verify patient and procedure.Midline laparotomy incision was performed.Bovie cautery was used to dissect down to the level of fascia, where fascia was opened, revealing a large amount of purulent material and underlying gore-tex mesh.The borders of mesh were exposed with substantial adhesiolysis and prolene sutures were resected.The entirety of the gore-tex mesh pulled from the surrounding fascia with purulence throughout.An underlying abscess was entered superiorly and laterally and drained of a substantial burden of purulent material.This was thoroughly irrigated.There was also an abdominal phlegmon consisting of parts of omentum, which was partially explored to confirm there was no abscess or fistula.The main peritoneal cavity was not entered.The wound was packed open.She was extubated and returned to the recovery room in stable condition.Dr.(b)(6) was present for the entire procedure.¿ specimens: infected mesh and cultures.Blood loss: 100 ml.Complications: none.Relevant medical information: on (b)(6) 2012: (b)(6) healthcare.Microbiology.Abscess culture.Specimen: abscess abdomen.Gram stain abscess: few polymorphonuclear white blood cells.Anaerobe culture: tissierella praeacuta.Routine culture: abdominal mesh.No growth day 2.Abdominal mesh gram stain: no organisms seen.No white blood cells seen.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-tex® soft tissue patch 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-tex® soft tissue patch 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.".
|
| |
|
Manufacturer Narrative
|
|
H6: updated investigation findings code.Conclusion code remains unchanged it should be noted that the gore-tex® soft tissue patch 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-tex® soft tissue patch 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.
|
| |
|
Manufacturer Narrative
|
|
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-tex® soft tissue patch instructions for use include warnings and addresses the following complications among others: ¿complications which may occur include, but are not limited to: infection, seroma formation, adhesions, hematomas, inflammation, fistula formation, and recurrence.¿ the instructions for use further warn: ¿any postoperative infection should be aggressively treated at the earliest possible time.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.
|
| |
|
Search Alerts/Recalls
|
|
|
