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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number |
1DLMCP06 |
| Medical Device Problem Code |
Insufficient Device Problem Information (3190)
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| Health Effect - Clinical Code |
Unspecified Infection (1930)
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| Date of Event |
10/08/2008
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Type of Reportable Event
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Serious Injury
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Additional Manufacturer Narrative
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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 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.".
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Event or Problem 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® plus 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: infection and removal.Additional event specific information was not provided.
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Additional Manufacturer Narrative
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H6: updated investigation findings code and health effect - impact code.Conclusion 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.
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Additional Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: [not provided] implant procedure: [not documented in the (b)(6) 2008 operative report, but on a later h&p, noted as ¿ventral hernia repair¿] [implant: gore® dualmesh® plus biomaterial, 1dlmcp06/05504336, 18 cm x 24 cm x 1 mm thick] implant date: (b)(6) 2008 [hospitalization dates unknown] (b)(6) 2008: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnosis: incisional hernia x2 with incarceration at panniculus.Small bowel obstruction.Morbid obesity.Postoperative diagnosis: [not provided].Anesthesia: general.Wound classification: [not provided] findings: ¿preoperative ct had indicated a loop of bowel within the abdominal wall at the caudad extent of her previous lower midline incision for colectomy.Her colectomy had been done at (b)(6) in 2006 for ruptured diverticulum.Also a loop of bowel was noted within the abdominal cavity above the umbilicus and to the left aspect of the midline.Ct had also indicated partial obstruction.¿ procedure: ¿the patient was placed on the operating room table in supine position after adequate and general anesthesia had been secured the abdomen was prepped and draped in the usual fashion.The entire procedure was extremely difficult due to this patient body habitus.Also, the previous midline incision was markedly thickened just below the umbilicus.We undertook midline incision below the umbilicus carrying this down through skin and subcutaneous tissue and going through very thick fascia.This was just superior to the large hernia which contain loop of distal jejunum.Once we safely entered the peritoneal cavity which was extremely difficult due to multiple adhesions and desire to avoid any enterotomy as we would use a prosthetic enclosure.We were able to finally open the incision inferior ward (sic).This allowed us to pull the small bowel loop out of the hernia sav and this loop was inspected.Although it was slightly thickened there was no evidence of a ischemia.We did observe peristalsis within this loop.At this point we tried to run the bowel, but this was impossible as we could not retrieve the bowel superior ward (sic).Therefore, we extended the incision around the umbilicus and cephalad, again, carefully continuing the incision with a #10 knife blade until the fascia was reached superior to the umbilicus.At this point we were able to insert our fingers at the inferior aspect just below the umbilicus and a bridge of very dense fascia was then slowly incised trying to avoid enterotomy of the underlying adherent loop.This was slowly taken down and once the fascia had been completely opened, we continued to take down the adhesions allowing the loop of bowel at the umbilicus to be taken down and then further went cephalad until loop of small bowel was also retrieved from the abdominal wall superior ward and to the left of midline.We continued to takedown adhesions.The transverse: was elevated.The ligament of treitz observed and the small bowel run to the ileocecal valve.We did not remove the appendix as we anticipated use of a prosthetic in trying to close her abdomen.Due to her very large body habitus and weight probably over 350 pounds, it was judged that we could not close the fascia with any real certainty that she would not incur additional incisional hernias.Therefore, at this point the abdomen was copiously irrigated with saline.We obtained a large piece of dual mesh which does have a smooth side to be placed down toward the peritoneal contents and a textured side to facilitate in growth from the abdominal wall posterior ward.This was a large piece approximately 18 cm x 24 cm.This was placed over the bowel and inserted below the fascial edge circumferentially.This gave nice closure.We then undertook to take this down to the fascia carefully avoiding circumferentially any impingement of bowel.Once this had been done and these sutures were placed approximately 1.5 cm apart and duel mesh was well down and at this point we placed two #2 ethilon retentions below the umbilicus.These were placed obviously above the fascia.We had opened all of the sacs which had been encountered to discourage any further incarceration.At this point once the retentions which held subcutaneous tissues and skin were placed, we did do an en mass closure with #1 prolene meeting in the middle and tying.At this point the skin was closed with staples.The two retention plastic bridges were placed and the retention was tied over then (sic).Dressing was placed.We did obtain a very large four panel abdominal binder.This was placed over the patient¿s abdomen prior to moving her from the table.With all sponge, tape, needle counts and instrument counts correct, the patient was transferred to the recovery room.Estimated blood loss was less than 100 cc with the patient having tolerated the procedure well.¿ (b)(6) 2008: (b)(6) hospital.Implant sticker: ¿gore dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp06.Lot batch code: 05504336.¿ (b)(6) 2008: (b)(6) hospital.Implant record: ¿implants/explants: or description: mesh dual mesh plus 18cm/24cm/1mm.Catalog #: 1dlmcp06.Serial#: [not provided].Type: implant.Size: [not provided].Cement: [not provided].Model#: [not provided] lot number: 05504336.Manufacturer: w.L.Gore.Qty: (b)(4).Implant/explant site: abdomen.¿ relevant information: [not provided] explant preoperative complaints: [not provided] explant procedure: (b)(6) 2008: (b)(6) md.Discharge summary: ¿following _____, the patient was taken to the operating room on (b)(6) 2008, at which time the patient underwent an abdominal wall component separation with resection of infected mesh and component separation repair.¿] explant date: date (b)(6) 2008 [hospitalization dates (b)(6) 2008] (b)(6) 2008: operative note: [not provided] (b)(6) 2008:(b)(6) md.Surgical pathology: ¿clinical information: the patient is a 51 year old woman with abdominal wall wound.¿ ¿gross description: the specimen is received fresh in two containers each labeled with the patients name and medical record number.The first container is further designated "abdominal tissue¿.Received is a 4.6 kg segment of skin and subcutaneous tissue which measures 66.0 x 24.0 x 10.5 cm.The specimen consists of darkly pigmented skin with focal areas of scar in the mid portion ranging in size from the 1.0 cm up to 2.5 cm.There is a linear vertical scar extending from the apparent umbilicus to the edge of the specimen measuring 15.0 cm in length.The mid portion of the specimen at the umbilicus is remarkable for an area of apparent wound which appears markedly inflamed and indurated.This area measures 15.0 cm in greatest dimension.Serial sectioning of this area reveals marked fibrosis and indurated underlying fat.Representative sections from the wound are submitted in cassettes a1 -a2.Serial sectioning the remainder of the specimen reveals unremarkable red -yellow lobulated fatty tissue and skin.Representative sections of the remainder of the specimen are submitted in cassettes a3 -a4.The second container is designated "abdominal mesh¿.Received is a fragment of synthetic white abdominal mesh measuring 19.0 x 15.0 x 0.5 cm.There is a scant amount of adherent fat noted on the mesh.This scant amount of adherent fat is submitted in cassette b1.¿ ¿diagnosis: a.Skin and soft tissue, abdomen, excision: ulceration, chronic inflammation, granulation tissue and foreign body giant cell reaction.Abdominal mesh, removal: fibroadipose tissue.Abdominal mesh identified.¿ (b)(6) 2008: (b)(6) md.Discharge summary: ¿diagnosis: infected abdominal wall mesh.History and physical: ms.(b)(6) is a 51 -year -old female with a complicated abdominal wound, which has expressed a gore -tex mesh at the base.The wound has also had some mild purulence at the edges with no signs of sepsis.¿ ¿abdomen: soft, nontender, and nondistended with no peritoneal signs, however, she does have expressed piece of approximately 6 cm of mesh in her mid abdomen paraumbilically.Hospital course: following _____, the patient was taken to the operating room on (b)(6) 2008, at which time the patient underwent an abdominal wall component separation with resection of infected mesh and component separation repair.The patient tolerated the procedure well.Postoperatively, she convalesced on the floor.However, on postoperative day #2, the patient developed some respiratory distress on the floor, was subsequently transferred to the icu for further management secondary to her tachypnea.The patient underwent ct angio of her chest, which revealed no ppe, as well as an ultrasound of bilateral groins, which revealed no dvt.The patient subsequently was transferred back to the floor.She was up and ambulatory with physical therapy, although she made slow progress.She did require oxygen despite use of her incentive spirometry.She did undergo a chest x-ray, which was normal.At the time of discharge, the patient was up and ambulatory, tolerating a regular diet; however, she did desaturate, at which time she was set up to go home with home oxygen.Discharge condition: good.¿ ¿instructions: the patient was instructed to ____ physical activity.The patient is to return to er or call in clinic, if fever, nausea, vomiting, redness, drains, bloods or wounds.The patient was instructed to continue with her jp drain, and was given jp drain instructions.¿ 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® 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.
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Additional Manufacturer Narrative
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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® plus 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: ¿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.
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