|
W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES; MESH, SURGICAL, POLYMERIC
|
Back to Search Results |
|
| Model Number 1DLMCPH07 |
| Device Problem
Insufficient Information (3190)
|
| Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
|
| Event Date 11/02/2007 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
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 with holes 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 with holes 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) 2006 whereby a gore® dualmesh® plus biomaterial with holes was implanted.The complaint alleges that on (b)(6) 2007, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection, pain, failed.Additional event specific information was not provided.
|
| |
|
Manufacturer Narrative
|
|
H6: updated investigation findings 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.
|
| |
|
Manufacturer Narrative
|
|
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 preoperative complaints: ¿ (b)(6) 2006: (b)(6) hospital.(b)(6) md.Indications: ¿the patient is a 58-year-old female with past medical history significant for arthritis, asthma, diabetes and a prior hernia repair 2 years ago.Unfortunately this repair got infected and the mesh had to be removed.The patient was seen by one of my colleagues several months ago and was noted to have a large left-sided abdominal wall hernia.Although it is easily reducible, it is causing her considerable discomfort.She has been thoroughly evaluated medically and is stable for surgery.More recently the patient had a ct of the chest, which raised some questions of possible reactive tb given her calcified lymph nodes; however, the patient stated that she had already been worked up for this.Since prior ct scans revealed the same pathology and has had biopsy of this area to rule out tb, the patient is stable for operative procedure and hernia repair.The risks and benefits were explained to the patient.¿ implant procedure: open incisional hernia repair with dual mesh.[implant: gore® dualmesh® plus biomaterial with holes, (b)(6) , 20cm x 30cm x 1.5mm thick] implant date: (b)(6) 2006 (hospitalization dates unknown).¿ (b)(6) 2006: (b)(6) hospital.(b)(6), md.Operative report.Surgical resident: (b)(6), md.Preoperative and postoperative diagnosis: incisional hernia.Anesthesia: general.¿ procedure: ¿after consent was obtained, the patient was taken to the or and placed in the supine position.After general endotracheal anesthesia was achieved, the orogastric tube was placed for gastric decompression.The patient's abdomen was then prepped and draped in the usual sterile manner.After the prepping and draping her skin was covered with a large sheet of ioban.A large defect encompassing 16 x 12 cm was palpated slightly left of midline.A 14-cm transverse incision was then made overlying the hernia defect and taken through the subcutaneous tissue using bovie cautery.The hernia sac was quickly visible and was entered using bovie cautery.We opened the hernia sac transversely and we were greeted with some underlying omentum.The hernia sac was then resected at its facial edges using bovie cautery.Omentum and some bowel attachments to the posterior aspect of the anterior abdominal wall were taken down using a combination of metzenbaum dissection and cautery dissection.The defect size was very deep given her body habitus, but we were able to get circumferential facial clearing for hernia repair.At this point the defect measured 16 x 14 cm.A large piece of dual mesh was then brought to the field and cut to 18 x 22 cm.It was initially tacked on all four quadrants in an inlay fashion.We made this so that the mesh could overlap the fascia below the level of the fascia.All four quadrants were initially tacked with #1 prolene stitches in an inlay fashion, and once all four stitches were placed and the mesh was tacked, the mesh was circumferentially tacked to the fascia using interrupted #1 prolene stitches, once again in an inlay fashion.Once the mesh was circumferentially tacked we felt the mesh was taut but not under too much tension.At this point some of the overlying facial tissue was reapproximated over the mesh using interrupted 2-0 vicryl stitches.A 15-french drain was placed over this and exited through the left lower quadrant.The drain was attached at the skin level using a 2-0 nylon stitch and attached to a bulb device.The wound was irrigated, and subsequently the subcutaneous tissue was re approximated using 2-0 vicryl stitches and skin was reapproximated using surgical staples.A sterile dressing was applied over the incision site as well as the drain site.An abdominal binder was placed over this.The patient's estimated blood loss was about 150 cubic centimeters.There were no complications.¿ ¿ (b)(6) 2006: (b)(6).Implant sticker.¿gore dualmesh® plus biomaterial with holes¿.Ref catalogue number: 1dlmcph07.Lot batch code: 03599110.W.L.Gore & associates.¿ (b)(6) 2006: (b)(6).(b)(6) , md.Pathology report.Specimen received: hernia sac.Clinical history: abdominal hernia.- diagnosis: soft tissue, abdomen, excision - fibroadipose tissue fragment consistent with hernia sac.- gross description: the specimen is received in formalin labeled with the patient¿s name and ¿hernia sac.¿ ¿it consists of two pieces of tan to brown fibrofatty tissue that measure 10.0 x 7.0 x 0.5 cm and 9.0 x 3.0 x 0.5 cm.Both are partially covered by a smooth, shiny tan-red surface that overlies unremarkable yellow-tan fibrofatty tissue.Sectioning reveals no identifiable lesions.Representative sections are submitted in one cassette.¿ relevant medical information: ¿ (b)(6) 2006: (b)(6) hospital.(b)(6) , md.Operative report.Assistant: dr.(b)(6).Debridement of infected abdominal wound.Preoperative and postoperative diagnosis: infected abdominal wound.Anesthesia: general.Indication: ¿the patient is a 58-year-old female with a past medical history significant for asthma, diabetes, and morbid obesity who underwent an open incisional hernia repair with mesh several weeks ago.I have been following her every week in my clinic for her abdominal wound which became infected.She initially had bacitracin placed and subsequently was switched over to wet-to-dry dressing changes.Unfortunately, it is not healing well, and she is complaining about more increasing abdominal pain.She denies any fever or chills, however.Her white count is 10.I am still optimistic that she has no involvement of her underlying mesh.¿ procedure: ¿after consent was obtained, the patient was taken to the or and placed in the supine position.After general endotracheal anesthesia was achieved, the patient's abdomen was prepped and draped in the usual sterile manner.An elliptical incision was made over the open abdominal wound encompassing some necrotic skin.This was done with bovie cautery, and some of the subcutaneous tissue was resected using bovie cautery.There was some necrotic tissue that was evident on the sides of the abdominal wound which was taken down sharply using metzenbaum dissections.We reached bleeding points along the walls of the abdominal wound, and there was some inflamed tissue.At the base, there was some necrotic tissue which was resected until firm tissue was appreciated.There was no obvious exposure of mesh, but the underlying base of that issue appeared somewhat inflamed.The wound was irrigated with copious amounts of saline and half-strength hydrogen peroxide and after we were happy with the hemostasis packed with wet kerlix.A sterile dressing was applied over this.The patient tolerated the procedure well.We will plan twice daily dressing changes on the patient with intravenous antibiotics.¿ (b)(6) 2007: (b)(6) hospital.(b)(6), md.Operative report.Assistant: (b)(6) , md.A debridement of an abdominal wound.Preoperative and postoperative diagnosis: chronically draining sinus.Anesthesia: general.Indication: ¿the patient is a 59-year-old female who underwent an incisional hernia repair more than a year ago.She has had some pain issues since that time but more recently has been asymptomatic.Her biggest issue is a chronically draining sinus that is only about 4 x 4 mm that tracks down about 3.5 cm.Because, despite wound packing, it has not closed, we will do a local debridement to try to get this area cleaned and for her to do wound care to this area to heal by tertiary intent.¿ procedure: ¿after consent was obtained, the patient was taken to the or and placed in supine position.After general endotracheal anesthesia was achieved, the patient abdomen was prepped and draped in the usual sterile manner.The sinus opening was inspected, and using a q-tip, we were able to determine the direction it was going.An elliptical incision was then made around the sinus tract.That was about 4 cm x 3 cm, and this elliptical incision was then taken through the subcutaneous tissue until we were flush with what appeared to be the fascia.We did not violate this since we felt that the mesh was just underneath this.We amputated the base of this dissected tissue using bovie cautery.On all the borders we got to healthy tissue.There was still some inflammation in the base of this wound.This was irrigated with betadine solution.There was some bleeding noted from the base which was a good sign.This was controlled with bovie cautery and a little bit of surgicel dressing.Once we were happy with the irrigation, the wound was packed with kerlix and covered with 4 x 4¿s and a sterile dressing.The patient tolerated the procedure well.Blood loss was minimal.¿ explant preoperative complaints: (b)(6) 2007: (b)(6) hospital.(b)(6) md.Indication: ¿the patient is a 59-year-old female with a significant past medical history, who more than a year ago underwent a hernia repair using dualmesh.The patient had some subcutaneous wound infection that had to be debrided in the or and did well initially.Then she developed a little fistulous tract that kept on draining.Initially we tried wound care to this, and although there was some improvement, it never stopped draining.She ultimately went back to the or for debridement of the wound to create a bigger wound, hopefully to get better wound packing.Unfortunately, this did not resolve her situation and, given the chronicity of the drainage, mostly likely it is secondary to a mesh infection.¿.
|
| |
|
Manufacturer Narrative
|
|
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.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.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® plus biomaterial with holes 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 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.
|
| |
|
Search Alerts/Recalls
|
|
|
