|
|
| Model Number 1DLMC07 |
| Device Problem
Insufficient Information (3190)
|
| Patient Problems
Unspecified Infection (1930); Seroma (2069); Hernia (2240); Tissue Breakdown (2681)
|
| Event Date 09/12/2008 |
|
Event Type
Injury
|
|
Event Description
|
|
It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2008 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2008, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: pain, encapsulation, erosion, adhesions and scarring, fistula, infection, recurrent hernia, migration of mesh, contraction.Additional event specific information was not provided.
|
| |
|
Manufacturer Narrative
|
|
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.".
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Manufacturer Narrative
|
|
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: (b)(6) 2008: (b)(6).(b)(6).Indications: ¿40 year old woman who presented with a ventral hernia from previous hepatic resection.Patient had chervon [sic] incision with midline extension.Hernia was located at the trifurcation.Under general anesthesia, the old scar which consisted of large keloid was removed.Incision was made over the previous incisional site and hernia sac was isolated and resected.Lysis of adhesion was carried out on the small bowel and colon which [sic] adherent to the hernia wall.The defect was 30x20 cm closed composite graft of marlex and gortex and secured interrupted 0 proline [sic] suture.¿ implant procedure: ventral hernia repair with composite marlex and gortex [sic] mesh.Lysis of adhesion [sic].[implant: gore® dualmesh® biomaterial, 1dlmc07/05446514, 20cm x 30cm x 1mm thick.] implant date: (b)(6) 2008 [hospitalization dates not provided].(b)(6) 2008: (b)(6).(b)(6).Operative report.Assistant #1: (b)(6).Assistant #2: vitale medical student.Preoperative diagnosis: ventral hernia.Postoperative diagnosis: same.Anesthesia: general.Estimated blood loss: 400 ml.Wound classification: not provided.Procedure: ¿patient was placed in a supine position under general anesthesia.Sterile region was created at the abdomen.The keloid of the chervon [sic] incision was excised.The hernia was located at the trifurcation.Incision was made over the previous incisional site.Electric cautery was used to divide the subcutaneous tissue and the hernia sac was isolated.The hernia sac was opened.There were extensive adhesion [sic] between the hernia wall and the small and large bowel.Lysis of adhesion was carried out.The fascia edges were identified.Dissection was carried out at [sic] the health [sic] fascia at least 6 cm beyond the edge of the hernia.The peritoneal area over the health [sic] fascia was dissected free from the small bowel.Repair with composite graft of marlex and gortex was carried out.The defect was about 30x25 cm.A piece of composite graft was cut into a [sic] elliptical shape.The graft was placed deep to the peritoneum and interrupted 0 proline [sic] sutures were placed from the fascia to the graft.All the sutures were placed when the graft is still outside the peritoneal cavity.After the completion of the placement of all the sutures, the graft was placed into the peritoneal cavity and sutures were tied.A half inch jackson pratt drain was placed and brought out the right side of the wound.The wound was closed with interrupted 30 [sic] vicryl subcutaneously followed by running 40 [sic] monocyl [sic ].¿ (b)(6) 2008: (b)(6).(b)(6).Implant sticker.¿gore dualmesh® biomaterial¿.Cat #: 1dlmc07.Lot #: 05446514.Expiration date: ¿2012-09-26.¿ explant preoperative complaints: (b)(6) 2008: (b)(6).(b)(6).Indication.¿the patient is a 40-year-old female who underwent ventral incisional hernia repair on (b)(6) 2008.This hernia was a result of previous surgery by chevron incision for multiple hepatic tumors.She was readmitted on 9/3/08 with a ¿seroma and/or hematoma surrounding the mesh.¿ special procedure was drained 450 ml of fluid from around this region and a vac [vacuum assisted closure] dressing was placed.Physical examination ultimately revealed mesh that was herniating from the fascial plane of the abdomen into the wound.The benefits, risks, and alternatives of operative intervention were discussed fully and frankly with ms.(b)(6).Risks including but not limited to bleeding, infection, scar, sensory disturbance or loss, fluid collection, blood collection, hernia and the need for additional treatments or surgery were discussed in detail.Given the presence of what just likely colonized or infected mesh, no placement of fascial patch would be undertaken on this procedure.The recurrence of the hernia was guaranteed and this was discussed in great detail.She understands that this represents a staged procedure and that the removal of the mesh and debridement of the abdominal wall was easy at first stage.We will ultimately be a multistaged process required to reconstruct the abdominal wall and reduce the hernia." explant procedure: debridement of abdominal wall, skin and soft tissues, incision and drainage of fluid collection of the abdominal wall; removal of prosthetic mesh.Explant date: september 12, 2008 [hospitalization dates not provided].(b)(6) 2008: (b)(6).(b)(6).Operative report.Preoperative diagnosis: open abdominal wound with mesh extrusion.Postoperative diagnosis: open abdominal wound with mesh extrusion.Anesthesia: general endotracheal by dr.(b)(6).Wound classification: not provided.Procedure: ¿the patient was placed in the supine position and general endotracheal anesthesia was administered.The abdomen was prepped with betadine solution and draped in sterile fashion.Along the previous chevron incision and laparotomy scars, incisions were made with a 10-blade scalpel through the skin and subcutaneous tissues into the periprosthetic plane.A large pocket was encountered and debridement was carried out sharply in addition to [sic] with curettes.Cultures were sent.The prosthetic mesh was identified and was removed completely and sent off the field as permanent specimen to pathology.Pulse lavage was used to vigorously irrigate the wound.After irrigation, lateral limb closure was carried out superficially with interrupted 2-0 nylon sutures.The central portion of the wound was packed with saline gauze.Bulky dry sterile and cotton-free gauze dressings were applied.The patient tolerated the procedure quite well.She was awakened and extubated in the operating room and delivered to the recovery room in stable condition." 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.
|
| |
|
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.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.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.¿ the instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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.Medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.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
|
|
|
