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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP08 |
| Device Problem
Insufficient Information (3190)
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| Patient Problem
Fistula (1862)
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| Event Date 05/09/2008 |
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Event Type
Injury
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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)].Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: exploratory laparotomy, excision of abdominal wall mass, closure of posterior fascia, and anterior abdominal wall hernia repair.Implant: gore® dualmesh® plus biomaterial ref: (b)(4); lot: 04351137.Implant date: (b)(6) 2007 [hospitalization (b)(6) 2007 ¿ discharge date n/a] (b)(6) 2007: (b)(6) university hospital ((b)(6)).(b)(6) m.D.Operative report.Pre- and postoperative diagnosis: abdominal wall mass.Anesthesia: general.Estimated blood loss: minimal.Indications: ¿the patient is a 48 -year-old who has a large anterior abdominal wall mass invading the anterior rectus fascia.It did not appear by ct scan to be invading any deeper structures.A previous incisional biopsy did net show evidence of sarcoma.Accordingly, given that it was painful and enlarging, it was decided that he would undergo an excision.Fully informed consent regarding all risks, benefits, and alternatives was discussed in detail including all reconstructive options as discussed with dr.(b)(6) team.¿ procedure: ¿after consent was obtained, the patient was brought to the operating room and underwent general anesthesia.The abdomen was prepped and draped in the usual sterile fashion.An elliptical incision was made around the obvious large anterior abdominal wall mass and a combination of sharp and, blunt dissection used to dissect down to the anterior rectus fascia which was circumferentially dissected free and the mass, skin, and anterior rectus fascia taken on bloc.The rectus and the posterior rectus fascia were left intact.He had a slight rectus diastasis and accordingly, this was closed.Attention was then turned to the reconstruction where a piece of dualex mesh was fashioned to the appropriate size and interrupted 0 ethibond sutures were used to parachute the 0 ethibond mesh down to the abdominal wall.Hemostasis was excellent.The incision was then irrigated and closed in layers.Dr.(b)(6) came in for local tissue rearrangement as will be dictated separately.All sponge needle, and instrument counts were correct x 2 at the end of the case.¿ (b)(6) 2007: (b)(6) university hospital ((b)(6)).Implant information: gore® dualmesh® plus biomaterial ref: (b)(4); lot: 04351137, w.L.Gore & associates.Size: 26 cm x 34 cm x 1.0 mm.Quantity: (b)(4).The records confirm gore® dualmesh® plus biomaterial (ref: (b)(4); lot: 04351137) was implanted during the procedure.Additional procedure: local tissue rearrangement for closure of soft tissue abdominal wall wound.(b)(6) 2007: (b)(6) university hospital ((b)(6)).(b)(6), m.D.[plastic surgeon] operative report.Pre ¿ and postoperative diagnosis: complex trunk wound.Acquired abdominal wall deformity.Anesthesia: general.Indications: ¿the patient is a 48-year-old man with abdominal wall tumor that dr.(b)(6) is planning to remove.The patient was discussed the reconstructive options as indicated in the reconstructive surgery consent given to him.Patient acknowledged the above and agreed to proceed with the procedure.¿ procedure: ¿after dr.(b)(6) had removed the tumor and reconstructed the abdominal wall with mesh, the soft tissue of the anterior abdominal wall was undermined, advanced by terms of local tissue rearrangement and closed in anatomical layers after the advancement.Sterile dressing was applied.Patient tolerated the procedure well, was then extubated and transferred to the operating room to recovery room.¿ relevant medical information: (b)(6) 2007: (b)(6) university hospital.Pathology report.Diagnosis: abdominal wall mass, excision: inflammatory pseudotumor (see comment).Comment: because a few atypical signet ring-like cells are noted, immunohistochemical stains will be performed to rule out the possibility of subtle involvement by a metastatic signet ring adenocarcinoma.The findings will be reported as an addendum.Immunohistochemistry report: the atypical cells demonstrate diffuse immunoreactivity with cd68 and negative reactions with pan-keratin and calretinin.This profile confirms the histiocytic nature of the cells and supports the diagnosis of inflammatory pseudotumor.Explant procedure: repair initial incisional or ventral hernia; excision of fistula tract; excision of dual mesh.[based on intraoperative record.No operative report provided.].Explant date: (b)(6) 2008 [hospitalization: (b)(6) 2008 ¿ discharge date unknown].(b)(6) 2008: facility not indicated.(b)(6) m.D.Intraoperative nursing notes.Preoperative diagnosis: ventral hernia.Postoperative diagnosis: hernia with loss of domain and enterocutaneous fistula tract.Anesthesia: general.(b)(6) 2008: facility ni.Implant information : ethicon proceed mesh.Size: 8¿ x 12¿.Expiration date: 12/2008.Quantity: (b)(4).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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Event Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2007 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: additional surgery; mesh removal; fistula; seroma; pain & suffering.Additional event specific information was not provided.
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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.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.¿ there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.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 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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Manufacturer Narrative
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H6: 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.
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