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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES; MESH, SURGICAL, POLYMERIC
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| Device Problem
Insufficient Information (3190)
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| Patient Problem
Unspecified Infection (1930)
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| Event Date 02/11/2013 |
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Event Type
Injury
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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) 2012 whereby a gore® dualmesh® plus biomaterial with holes was implanted.The complaint alleges that on (b)(6) 2013 and (b)(6) 2017, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection, mesh removal, recurrence, adhesions, pain and suffering.Additional event specific information was not provided.
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Manufacturer Narrative
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(b)(4).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 preoperative complaints: on (b)(6) 2012: (b)(6) healthcare system, (b)(6) hospital.(b)(6), m.D.Indications: ¿this patient has had previous midline incision.A hernia was occurring around the umbilicus.It looked like it was partially the result of an umbilical hernia which was pre-existing and an incisional hernia.¿ implant procedure: repair of large ventral hernia with 16 x 20 mesh.[implant: gore® dualmesh® plus biomaterial with holes, 1dlmcph04/no information, 15cm x 19cm x 1.5 mm thick, oval with holes] implant date: (b)(6) 2012 [hospitalization (b)(6) 2012].Wound classification: [not provided].On (b)(6) 2012: (b)(6) healthcare system, (b)(6) hosptial.(b)(6), m.D.Operative report.Anesthesia: general/endotracheal.Preoperative and postoperative diagnosis: ventral hernia.Findings: ¿the patient had a chronic ventral hernia.We were able to reduce this totally.The fascia was not distributed that was intact.We did free the omentum and intestine from the wall and were able to place a 16 x 20cm dual mesh graft.¿ procedure: ¿with the patient in the supine position under satisfactory endotracheal anesthesia the abdomen was prepped and draped in the usual sterile fashion.And incision was made at the level of the umbilicus.The hernia sac was identified and then dissected free from the surrounding tissue.The hernia was then reduced into the abdominal cavity.The sac was resected.We then placed 2-0 prolene sutures on the 16 x 20 mesh.We had six sutures present.These replaced appropriately and then the abdominal wall was brought upward.We then placed several stitches in between some of the fixations to prevent any bow from herniating into the potential defect around the fixation points.The fascia was then closed with 0 prolene.Irrigation was accomplished.The abdominal wall was then closed in layers.Sterile dressings were applied.The patient was then awakened and taken to recovery in satisfactory condition.¿ on (b)(6) 2012: (b)(6) healthcare system, (b)(6) hospital.Implant record: inventory item: ¿mesh srg dualmesh plus 19x15cm soft tiss biomaterial antimicrobial hole strl gore-tex chlorhexidine¿.Implant name: ¿mesh dual plus holes 1.5mm x 15x19cm - log201786.¿ model/cat no: 1dlmcph04.Manufacturer: wl gore and associates.Number used: 1.Area: abdomen.Relevant medical information: on (b)(6).(b)(6) 2013: (b)(6) hospital.[operative report for explant not provided.] on (b)(6).(b)(6) 2013: (b)(6) hospital.(b)(6), m.D.Surgical pathology report.Tissue submitted: umbilicus and infected mesh.¿final diagnosis: umbilicus and mesh; hernia repair: skin and subcutaneous tissue with fibrosis, fat necrosis, foreign body granulomatous inflammation and hemosiderin deposition.Synthetic mesh material, see gross description.¿ gross description: ¿the specimen labeled (b)(6) and ¿umbilicus and infected mesh¿ is received in formalin and consists of a 15.3 x 10.1 x 0.2 cm rectangular shaped portion of synthetic yellow-green mesh like material.Multiple unoriented blue suture ties are embedded within mesh-like material.No sections are taken.Also submitted in the same container is a 7.6 x 6.6 x 3.9 cm irregular shaped portion of soft, yellow-tan glistening adipose tissue with an attached 3.5 x 2.7 cm ellipse of wrinkled yellow-tan skin.Centrally located on the portion of the skin is a 0.6 cm in greatest dimension puckered possible umbilicus.The specimen is serially sectioned and the cut surface reveals soft yellow-tan glistening adipose tissue and dense green-white fibrous tissue.Evidence of the yellow white fat necrosis is identified filling the dense grey-white yellow green fibrous tissue.Two representative sections are submitted in two cassettes.Microscopic description: microscopic examination of the tissue processed is performed.¿ [microscopic description not provided].On (b)(6) 2017: (b)(6) hospital.(b)(6), m.D.Operative report.Repair of recurrent incisional hernia with mesh, lysis of adhesions, small bowel resection.[implant: phasix overlay].Assistant: (b)(6), cst.Anesthesia: general.Estimated blood loss: 150ml.Pre-operative diagnosis: recurrent ventral incisional hernia.Post-operative diagnosis: recurrent ventral incisional hernia.Findings: ¿multiple adhesions.¿ procedure: ¿the patient was brought to the operating room and transferred on the operating room table in the supine position.Scd's (sequential compression device) were placed on bilateral lower extremities, general anesthesia was induced, and the patient was successfully intubated.A foley catheter was placed under sterile conditions.The abdomen was prepped and draped in the usual sterile fashion, and time out was performed.She received clindamycin iv.A lower midline incision was made with a scalpel.I carefully dissected down with the electrocautery, through the subcutaneous tissue, until we encountered the hernia.There was a large hernia sac.The bowel was very adherent to this.The edges of the fascia were grasped.The hernia sac was dissected off.I then began a tedious lysis of adhesions.These were all up to the anterior abdominal wall.Inherent to the procedure, there was one serosal injury that was over showed with several silk stitches.Also, due to the intense adhesions, the small bowel was entered.A small bowel resection was performed.The mesentery was circumvented and taken down with the ligasure device.Two small enterotomy's were made to circumvent the defect.The gia blue load 80 stapler was introduced.This was fired to create anastomosis.In additional firing was required to close the anastomosis.The mesenteric defect was closed with a 3-0 vicryl stitch.Once all of the adhesions were taken down, the facial edges were grasped.These were cleared off circumferentially.The fascia was then closed with a #1 pds; one from the top of the incision, one from the bottom.These were met in the middle and tied off.The fascia was irrigated.I made sure there was adequate hemostasis.A piece of 15 x 20 cm of phasix mesh was placed as an overlay.This was tacked down to the underlying fascia with a 2-0 vicryl stitches.An 18 (b)(6) was placed on top of the mesh.A small stab incision was made in the left lower quadrant.This was sutured in place with a nylon stitch.The tissue was then tacked down to the phasix mesh with interrupted 2-0 vicryl stitches.The dermis was closed with a running 3-0 vicryl stitch.Skin stapler was used to close the incision.The patient was then awakened, extubated, the foley catheter was removed, and the patient was transferred to recovery room in stable condition.¿ on (b)(6) 2017: (b)(6) hospital.¿specimens: suture granuloma: culture, aerobic.Culture anaerobic, smear, gram stain.Small bowel: tissue.Small bowel.Pathology surgical.Hernia sac: tissue.Soft tissue.Pathology surgical.[pathology report not provided for specimens that were collected during the (b)(6) 2017 procedure.] 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 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.".
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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.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.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.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.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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