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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problem
Unspecified Infection (1930)
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| Event Date 07/13/2010 |
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Event Type
Injury
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Manufacturer Narrative
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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 #1 preoperative complaints: none provided.Implant #1 procedure: repair of complex ventral hernia with ¿gore-tex dual mesh¿.Extensive lysis of adhesions.Implant: gore® dualmesh® plus biomaterial (1dlmcp04/(b)(4)).Implant #1 date: (b)(6) 2009 (hospitalization (b)(6) 2009) (b)(6) 2009: (b)(6) medical center (b)(6).(b)(6).Operative report.Preoperative and postoperative diagnosis: complex ventral hernia.Anesthesia: general.Estimated blood loss: minimal.Drains: blake drains x2.Description of procedure: ¿after successful induction of general tracheal anesthesia, the abdomen was prepped and draped in usual sterile manner.Previous excision [incision] was excised and the hernia sac entered and abdomen entered and multiple adhesions were taken down over next hour and a half.At this point, it was noted that she had diastasis of the rectus muscle, along with a complex ventral hernia, so extensive lateral dissection of the subcutaneous tissues to the rectus muscle was performed.At this point, the dual was inserted and tacked in position with interrupted 0 prolene, taking care to incorporate the rectus muscle with a through and through transfascial suture and then through and through the gore-tex dual mesh.The sutures were placed approximately 1 cm apart.All the way around the gore-tex was pulled tight.At this point, the fascia was closed with interrupted 0 prolene and blake drains were placed in the subcutaneous tissues and brought out separate stab wounds.Subcutaneous tissues reapproximated using interrupted 3-0 vicryl, skin closed with staples.The wound was injected with 0.25% marcaine.Instrument and sponge counts correct x2.Sterile dressing applied.The patient taken to recovery room in good condition.¿ (b)(6) 2009: (b)(6) medical center (b)(6).Implant sticker.Gore® dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp04.Lot batch code: 05784106.Manufacturer: w.L.Gore & associates.Ah1382-ml1.(b)(6) 2009: (b)(6) medical center (b)(6).Surgical pathology.(b)(6).Accession: (b)(4).Tissue, ventral hernia sac.Gross description: received is an irregularly shaped pigmented skin excision measuring 83.0 x 30.0 x 20.0 mm.The umbilicus is present centrally.The subcutaneous tissue is yellow and lobulated to firm and pink.The specimen is sectioned revealing pale to yellow lobulated soft tissue.Cassette summary: 1.Umbilicus; 2.Nearby tissue.Implant #2 preoperative complaints: none provided.Implant #2 procedure: exploratory laparotomy.Extensive lysis of adhesions.Component separation technique of abdominal repair with ¿dual mesh gore-tex mesh¿.Implant: gore® dualmesh® plus biomaterial (1dlmcp04/(b)(4), oval, 15cm x 19cm x 1mm) implant #2 date: (b)(6) 2009 (hospitalization (b)(6) 2009) (b)(6) 2009: (b)(6) medical center (b)(6).(b)(6).Operative report.Preoperative and postoperative diagnosis: recurrent complex ventral hernia.Anesthesia: general.Estimated blood loss: 200 ml.Drains: foley catheter.Blake drain x2.Description of procedure: ¿after successful induction of general tracheal anesthesia, the abdomen was prepped and draped in usual sterile manner.A midline incision the old scar was excised in the peritoneum.The hernia sac was entered and there were multiple adhesions of small bowel to the hernia sac.This took approximately 2 hours with very tedious dissection to take the small bowel adhesions down from the hernia sac.There were no small bowel enterotomies made, and the small bowel was reduced inside the fascia, and gore-tex dual mesh was then tacked at 12, 3, 6, 9 o'clock with 0 prolene, and then between each of those 2 interrupted sutures were used to tack it to the underside of the rectus muscle.At this point, a relaxing incision lateral was performed and the fascia was closed over the mesh with interrupted vertical mattress #1 prolene.The subcutaneous tissues were irrigated and closed with a running 3-0 vicryl.Skin closed with staples.Instrument and sponge counts correct x2.Sterile dressing applied.The patient was taken to recovery room in good condition.Note, this procedure normally takes only about 1 hours, but due to the very tedious and difficult dissection and complexity of this operation, it took almost 3 hours.¿ (b)(6) 2009: (b)(6) medical center (b)(6).Implant sticker.Description: ¿gore dual teflon plus.¿ oval 15cm x 19cm x 1mm.#1dlmcp04.Lot number: 06304981.Qty: 1.Explant preoperative complaints: (b)(6) 2010: (b)(6) medical center (b)(6).(b)(6).Radiology.Ct abdomen/pelvis.Reason: abdominal pain.¿ct of the abdomen is the first ct of the abdomen we have on this patient in this institution.A previous ultrasound had shown gallstones.The patient has a history of a previous infection and previous repair of anterior abdominal wall with gortex.Today's study shows the intraabdominal contents to be essentially normal excluding the anterior abdominal wall.I don't see an intraabdominal abscess.The patient has a large amount of fluid around a metallic iatrogenic structure.By history, the patient has had a gortex mesh-type material placed in the anterior abdominal wall for repair of hernia.The metallic containing structure may represent an iatrogenic gortex mesh device although it is unusual and my first thought was that this might be a retained sponge, and i still can't exclude that as a possibility.There is fluid surrounding this foreign body.There is a small amount of dark density within the foreign body suggesting gas and i suspect that this foreign body is infected.The infection appears to involve the subcutaneous fat around the anterior abdominal wall and the anterior abdominal wall itself.I don't see any other abnormalities.Impression: ¿inflammatory fluid and gas surrounding iatrogenic metal containing density in anterior abdominal wall.Abscess suspected.¿ pelvis: ¿ct of the pelvis shows normal pelvic structures.The abnormal process in the anterior abdominal wall extends down to the anterior pelvic wall below the umbilicus.I don't see any other abnormalities.¿ explant procedure: exploratory laparotomy.Removal of infected gore-tex mesh.Repair of ventral hernia with stratus [sic] mesh.Explant date:(b)(6) 2009 (hospitalization (b)(6) 2010) (b)(6) 2010: (b)(6) medical center (b)(6).(b)(6).Operative report.Preoperative and postoperative diagnosis: infected gore-tex mesh.Assistant: dr.(b)(6).Anesthesia: general.Estimated blood loss: 100 ml.Drains: blake drains x3.Description of procedure: ¿after successful induction of general endotracheal anesthesia, the abdomen was prepped and draped in the usual sterile manner.The previous incision was reopened, carried down through the copious amounts of subcutaneous tissues, and the gore-tex mesh identified, and carefully removed.There was a lot of granulation tissue beneath the gore-tex mesh, and so entering the peritoneal cavity was quite difficult.At this point, it was felt best not have a bowel injury, so the fascia was closed over a blake drain with interrupted #1 prolene.Stratus [sic] mesh was then tacked over the repair to the fascia using interrupted 0 prolene followed by a running 0 prolene.And 2 blake drains were placed over the stratus [sic] mesh and brought out a separate stab wounds.All this was irrigated with copious amounts of normal saline.There was no further purulent drainage noted, and the culture and sensitivity had previously been done.Subcutaneous tissues were reapproximated with running 3-0 vicryl, skin closed with staples.Instrument and sponge counts correct x2.Sterile dressing applied and the patient taken to recovery room in good condition.¿ (b)(6) 2010: (b)(6), cdt.Pathology report.Surgical wound culture, abdomen: 4+ (b)(6).1+ pseudomonas aeruginosa.(b)(6) 2010: (b)(6), cdt.Pathology report.Tissue culture, abdomen: 2+ (b)(6).4+ pseudomonas aeruginosa.Relevant medical information: (b)(6) 2011: admission to (b)(6) medical center (b)(6).(b)(6) 2011: (b)(6), md.Operative report.Preoperative and postoperative diagnosis: recurrent ventral hernia.Procedures: exploratory laparotomy, extensive lysis of adhesions, cholecystectomy, component separation, repair of complex ventral hernia with strattice mesh 20 x 20 cm.¿a midline incision was made, carried down through the copious amounts of adipose tissue and the midline encountered and the abdomen entered.The incision was carried inferiorly and the hernia was carefully dissected out.Then for the next 2 hours, lysis of adhesions was performed.At this point attention was turned to the gallbladder which was removed ¿ at this point, the component separation was performed in the usual fashion by saving the perforating vessels to the skin and going out to the internal oblique fascia and incising the fascia from the ribcage down to the pelvis on both sides.There was some hernia sac that was resected, along with some old strattice mesh.The abdomen was then closed in the usual fashion with interrupted #1 prolene without tension.Strattice mesh was then tacked in only fashion over the repair with a running suture laterally, taking care not to incorporate the perforating vessels.The blake drain was placed beneath the strattice mesh and brought out a separate stab wound.Interrupted prolene was then used to tack the fascia down to the anterior fascia.Subcutaneous tissues were irrigated with copious amounts of normal saline.Subcutaneous tissues were reapproximated using interrupted 3-0 vicryl.Skin closed with staples.¿ ¿the operation took approximately 5 hours, which is considerably longer than normal due to the extensive nature of disease.¿ (b)(6) 2011: (b)(6), md.Pathology report.Surgical specimen: a.Gallbladder.B.Ventral hernia repair.¿gross description: a.Firm, pink congested saccular gallbladder measuring 94 x 28 x 23 mm.B.Received are ten portions of yellow and lobulated to pink fibrous soft tissue measuring 25 to 74 mm.Skin surfaces are not identified.Blue suture material is present in several of the specimens.¿ (b)(6) 2012: admission to (b)(6) medical center (b)(6).(b)(6) 2012: (b)(6), md.Radiology.Ct abdomen/pelvis.Reason: abdominal pain and drainage from surgical incision to abdomen.Comparison: (b)(6) 2011 ¿ had large umbilical hernia that appears to be repaired.Impression: no evidence of acute intraabdominal abnormality.Large midline anterior wall wound infection in the region of the umbilicus presumably representing surgical site for repair of hernia.Pelvis: normal.(b)(6) 2012: (b)(6), md.Radiology.Percutaneous drainage of abscess along the anterior abdominal wall in the midline of the lower abdomen.Approximately 80 cc pus removed.Jackson-pratt drains for external drainage.(b)(6) 2012: (b)(6), cst.Pathology report.Culture anterior abdominal wall drainage.1+ (b)(6).(b)(6) 2012: (b)(6), md.Operative report.Wound aspiration with incision and drainage of abdominal wall abscess.Preoperative and postoperative diagnosis: abdominal wall abscess, status post placement of stratus mesh.Findings: the patient had two draining areas which went down into a necrotic cavity.There was no excessive amount of undrained pus present.Summary: ¿i first removed the drain that radiology had placed ____ [sic].I probed both of these tracts.They went down to the same deep necrotic cavity.The stratus was intact.There was no sign of any hernia recurrence or foreign body rejection at the abdominal fascial level.The necrotic tissue was removed.Any occult pus was verified to be drained.The area was opened up.Hemostasis was obtained with electrocautery.The area was packed with gauze.¿ (b)(6) 2012: (b)(6) medical center (b)(6).(b)(6), md.Operative report.Abdominal wound exploration.Drainage of abdominal abscess/debridement of necrotic tissue at the fascial level.Placement of a wound vac.Preoperative and postoperative diagnoses: chronic draining abdominal wound with deep fluid collection at the level of the fascial closure.Indication: ¿she has previously undergone an exploration of this area and the fascia was felt to be intact.She also had ct guided drainage of the area.Neither one of these completely healed the area of concern and it is right down to the fascial level based on a new ct scan which demonstrates that the fascia appears to be intact; however, there is a fluid collection just above this with persistent drainage from her skin.¿ ¿ procedure summary: ¿there were 2 sinus tracks.I dissected through previous scar tissue down to a large chronic abscess cavity.I would estimate this as about 10 x 4 cm in size.There is necrotic, fatty tissue at the base of the muscle level.It again looks and feels to be intact with no obvious recurrent hernia.I drained the fluid down at the base of the incision at the abdominal wall level.I debrided all of the necrotic tissue, irrigated the area and then obtained hemostasis with direct electrocautery.Finally, i measured the area and used the medium wound vac sponge, placed it at the base and placed a wound vac using standard techniques.¿ 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 Description
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It was reported to gore that the patient underwent ventral hernia repair on (b)(6) 2009 whereby a gore dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2010, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: mesh removal due to infection.Additional event specific information was not provided.
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Manufacturer Narrative
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Added medical history: 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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Manufacturer Narrative
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Updated results code.Conclusion code remains unchanged.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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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.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.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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