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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 05/07/2007 |
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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)].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 open ventral hernia repair on (b)(6) 2006 whereby a gore® dualmesh® plus biomaterial 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: mesh became infected and failed resulting in recurrence resulting in removal of mesh and repair with additional mesh implant.Additional event specific information was not provided.
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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 procedure: repair of ventral incisional hernia with dual mesh plus measuring 19 x 15 cm.Implant: gore® dualmesh® plus biomaterial [1dlmcp04/04375980, 19 x 15 cm] implant date: (b)(6) 2006 (hospitalization [ni]).(b)(6) 2006: (b)(6) medical center.(b)(6).Operative report.Preoperative diagnosis: large ventral incisional hernia.Postoperative diagnosis: large ventral incisional hernia.Assistant: (b)(6).Anesthesia: general endotracheal.Estimated blood loss: negligible for out part of the operation.Findings and operative technique: indications: ¿this 44 years old female patient who underwent previous gastric bypass surgery for morbid obesity lost a lot of weight and scheduled herself for a panniculectomy by dr.Alghanem in plastic surgery also developed a hernia that has been symptomatic in the incision.She wanted repair simultaneously and the risk and complications and the type of repair including using the mesh were all explained to the patient.Complications explained included but were not limited to bleeding, infection, recurrence, need to remove the mesh if it became infected, possible bowel injury, possible other visceral injury, dvt and pe, and other complications were all explained to the patient who understood, agreed and wanted to proceed.With the patient in the supine position and under general endotracheal anesthesia and after dr.Alghanem raised the flaps, we were called to repair the hernia.The hernia sac was identified in the subcutaneous tissue and followed down all the way to the fascial edges and then the sac was opened and the adhesions between the omentum and the sac were removed using blunt and sharp dissection with good hemostasis, no bleeding.Then the sac was resected and was very large sac and submitted to pathology.Then the fascial edges were freshened and dissected very nicely to about an inch and a half to 2 both anteriorly and posteriorly, then a piece of mesh measuring 19 x 15 cm was chosen to fit the defect that was slightly smaller than that and then we repaired it keeping the smooth yellow face facing the abdominal cavity and the white roughened face towards the fascia and subcutaneous tissue.This was put in place using running continuous suture of no.1 prolene.After finishing that repair all around the hernia defect, it was tested and there was no tenseness, no tension at all and no looseness.The wound was irrigated well and then the anterior edge of the fascia was approximated again in front of the mesh to the midline using the same suture material.The wound was irrigated again and then dr.Alghanem was called to finish the operation and he will do his own dictation and his own sponge count and instrument and needle counts; however, out counts, needle, sponge and instruments were all accurate according to the nurses at the end of our procedure.The condition of our patient at the end of the procedure was stable.¿ (b)(6) 2006: (b)(6) medical center.Implant sticker.Gore dualmesh® plus biomaterial.Catalogue number: 1dlmcp04.Lot batch code: 04375980.W.L.Gore & associates.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp04/04375980) was implanted during the procedure.Explant procedure: excision of infected mesh from anterior abdominal wall.Repair of recurrent ventral incisional hernia.Implantation of alloderm acellular matrix as an interposition graft for the above recurrent hernia repair.Explant date: (b)(6) 2007 (hospitalization [ni]).(b)(6) 2007: (b)(6) medical center.(b)(6).Operative report.Assistant: (b)(6).Preoperative diagnosis: infected hernia mesh.Postoperative diagnosis: infected hernia mesh.Indication: patient had a draining sinus tract with purulent material in her midline incision that has been present for approximately 8 months, has been refractory to antibiotics.Surgery is indicated to remove infected material, repair hernia and prevent ongoing infection.Findings and operative technique: ¿patient is taken to the operating room.General anesthesia was obtained.She is prepped and draped in the usual sterile fashion.Midline incision was made around the area of the umbilicus and the sinus tract was encountered.The purulent material was able to be tracked superiorly to the mesh between the umbilicus and the xiphoid process and leading to a piece of gore-tex dualmesh.Incision was then extended up to the xiphoid and using sharp and blunt dissection the prolene sutures and gore-tex suture material were excised.Simpulse lavage 3 liters was used to remove anymore infected material.When all necrotic infected material had been sharply and bluntly debrided, an 8 x 16 piece of alloderm was brought into the operative field.Due to the fact that it was infected in nature, no.1 maxon suture was used instead of prolene.The alloderm was placed below the fascia in an underlay fashion and secured with no.1 maxon suture.Abdominal wall was again irrigated and then fascia was reapproximated on top of the alloderm again using a running no.1 maxon suture.Hemostasis was obtained.Skin was closed with staples.The patient was taken to the recovery room in satisfactory condition having tolerated the procedure well.¿ (b)(6) 2007: (b)(6) medical center.Implant sticker.Alloderm® regenerative tissue matrix.Relevant medical information: (b)(6) 2007: (b)(6) medical center.(b)(6).Pathology.Accession #: s07-4442.Specimen received: infected mesh and portion of abdominal wall.Clinical history: infected mesh graft ventral hernia, had ventral hernia repair with mesh, draining opening sub-umbilicus.Pre-operative diagnosis: not provided.Post-operative diagnosis: not provided.Gross description: received in formalin and labeled ¿infected mesh and portion of abdominal wall¿ is a sheet of white synthetic mesh material measuring 12 x 10 cm.Also received is a portion of firm tan hemorrhagic fibrous tissue with tags of yellow adipose tissue measuring 8 x 5 x 1.7 cm.A representative section is submitted in one cassette.Final pathologic diagnosis: resected portion of abdominal wall and mesh.Fibroadipose tissue containing dense fibrosis with chronic inflammation and foreign body reaction including foreign body giant cells near small fragments of foreign material, consistent with the clinical diagnosis.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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Manufacturer Narrative
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H6: updated results 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.
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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated type of investigation.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.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 material.¿ 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.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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