W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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Model Number 1DLMCP02 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Erosion (1750); Unspecified Infection (1930); Tissue Breakdown (2681)
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Event Date 06/19/2017 |
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 laparoscopic ventral/incisional hernia repair on (b)(6) 2008 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2017, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection, revision/removal surgery.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: 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 procedure: laparoscopic ventral incisional herniorrhaphy with gore-tex dual mesh plus.Laparoscopic enucleation of an ovarian cyst.Implant: gore® dualmesh® plus biomaterial [1dlmcp02/05798681, 1mmx8x12cm] implant date: (b)(6), 2008 (hospitalization (b)(6), 2008) (b)(6) 2008: (b)(6) hospital.(b)(6), md.Operative report.Assistant: (b)(6), do.Preoperative diagnosis: ventral incisional hernia.Postoperative diagnosis: ventral incisional hernia and left ovarian cyst.Anesthesia: general.Complications: none.Estimated blood loss: minimal.Urine output: 400 ml.Fluids: 1600 ml crystalloid.Preoperative medications: vancomycin.Indications for procedure: the patient is a 41-year-old female who is status post bilateral tram flap reconstruction as a result of breast cancer.She did have an area of necrosis requiring multiple abdominal reconstructions as well as most recently alloderm placement and skin grafting to the lower portion of her wound.This has failed and she has developed a hernia approximately 7 x 5 cm.She was subsequently consented for repair.Operative procedure: ¿the patient was brought to the operating room and placed in the supine position.After initiation of general anesthesia by the anesthesia department, a foley catheter and orogastric tube was placed to decompress the bladder and stomach respectively.The arms are tucked at her side with care taken to pad all bony prominences.The abdomen was prepped and draped in normal sterile fashion.Access to the abdominal cavity was gained using a 5 mm trocar placed in the right upper quadrant subcostal position.Pneumoperitoneum to 15 mmhg occurred without difficulty.Two other trocars, 12 mm and a 5 mm were placed along the anterior axillary line on the right side.There was omental attachments to the anterior abdominal wall and to the undersurface of the alloderm and skin graft.The attachments were divided using the hook electrocautery as well as the harmonic scalpel.After dividing the attachments to the alloderm and skin graft, we deflated the abdomen and waited approximately 15 minutes to make sure the integrity of the skin was appropriate and that this was viable skin.It was and we subsequently proceeded with mesh repair.The defect measured 7 x 5 cm.We chose an 8 x 10 piece of dual mesh plus, this was marked appropriately using #0 polysorb suture and entered this into the abdomen.The mesh was suspended using the tension sutures of #0 polysorb and packed in place using a 5 mm protac.The fascial edges were very much demarcated as the result of previous mesh repairs.Once we positioned the mesh appropriately, with approximately 3 cm of overlap in all directions, we then placed multiple sutures in a transabdominal fixation manner using #1-0 pds.These were placed without difficulty and the mesh was secured appropriate, then further staples of the 5 mm protac we used to [sic] the mesh to the anterior abdominal wall.At this point upon further evaluation of the abdomen, there was noted to be a large 7 cm cyst of the left ovary that also had another 4 cm cystic component.The cyst was manipulated and popped without difficulty yielding clear fluid.The clear fluid was aspirated and sent for cytologic interpretation.There were two cysts noted and the bigger of the two cysts were able to easily shell out the inner lining of the cyst cavity, retrieve this and sent it to pathology for pathologic interpretation.The second cyst, the cystic wall cavity fell apart much easier and was taken apart in pieces.This was also removed for pathologic interpretation.Hemostasis was obtained using the harmonic scalpel.At this point #0 polysorb sutures were used to close the fascial defect of the 12 mm trocar.The pneumoperitoneum was evacuated and the fascia tied and secured.The wounds were closed using #4-0 polysorb and a dry sterile dressing and abdominal binder were placed on the patient.Intraoperative consultation with dr.Mcknight was performed and we will consult the patient for management of her cystic disease as well as her large uterus (the patient is on hormonal therapy/tamoxifen as a result of her breast cancer).¿ (b)(6) 2008: (b)(6) health system.Implant record.Device description: mesh, hern 2 + ovl 1mmx8x12cm eptfe.Site: abdomen.Expiration date: 01/23/2011.Manufacturer: w.L.Gore & associates inc.Quantity: 1.Lot#: 05798681.Mfg catalog#: 1dlmcp02.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp02/05798681) was implanted during the procedure.Explant procedure: removal of infected mesh and debridement of subcutaneous tissue and fascia.Explant date: (b)(6), 2017 (hospitalization (b)(6), 2017) (b)(6) 2017: [facility ni].(b)(6), md.Operative report.Assistants: (b)(6), md.Preoperative diagnosis: infected gore-tex mesh.Postoperative diagnosis: infected gore-tex mesh.Indications for procedure: this is a 49-year-old woman with a history of metastatic breast cancer, who presented with erosion of her gore-tex mesh through her abdominal skin with subsequent chronic infection.Description of procedure: ¿after obtaining informed consent, the patient was taken to the or and placed supine on the operating room table.General endotracheal anesthesia was initiated.A formal time-out was performed.Preop antibiotics were administered and the patient¿s abdomen was prepped and draped in usual sterile fashion.The wound where the mesh is exposed was cultured.The gore-tex mesh was not incorporated anteriorly with an exudative fluid over it.We then made a vertical incision across the lower abdomen including the area of mesh erosion.The soft tissues which consisted entirely of scar were divided using electrocautery until the mesh was exposed.The gore-tex mesh was circumferentially divided away from the abdominal wall, into which it was noted to be poorly incorporated.Many metal tacks and prolene sutures were removed along with the mesh and once we had gotten the entirety of the mesh, the abdominal contents were inspected and found to be free of injury.In order to remove the mesh we debrided some of the anterior abdominal wall fascia leaving abdominal muscle out of harm¿s way.She also had some woven nylon mesh around the edges of the wound, but this was very well incorporated within the soft tissues.In order to be sure that it was not infected, superiorly we debrided and excised some of this mesh with abdominal wall fascia but left the upper abdominal wall mesh woven mesh intact as it did not appear infected and excision of this would have required in an extensive abdominal wall reconstruction.Thus, we elected to leave the incorporated mesh behind and proceeded to close the abdominal wall in full thickness fashion using interrupted 0 vicryl sutures with interrupted staples to endorse skin closure.Sterile dressing and abdominal binder were then placed, and the patient was awakened, extubated, and taken to pacu in stable condition.Dr.(b)(6) was present for the entire procedure.¿ dictated by: (b)(6), md.(b)(6) 2017: [facility ni].(b)(6), md.Operative note.Pre-op diagnosis: infected prosthetic mesh of abdominal wall.Ventral hernia without obstruction or gangrene.Post-op diagnosis: infected prosthetic mesh of abdominal wall.Procedure: debride necrotic skin/tissue, abdominal wall.Remove mesh from abdominal wall for infection.Specimens: swab, abdominal abscess: anaerobic.Abdominal mesh, unknown manufacturer-explanted.Surgeon evaluation of wound class: iv, dirty: old traumatic wounds, devitalized tissue or existing infection or perforation or organisms present before procedure.Findings: infected gortex mesh.Relevant medical information: (b)(6) 2017: (b)(6).(b)(6), pac; (b)(6), md.Discharge summary.Admitting diagnosis: mesh erosion, metastatic breast cancer.Procedure during hospitalization: removal of infected mesh and debridement of subcutaneous tissue/fascia (b)(6) 2017.Referred to us for evaluation of chronic abdominal wound with gortex mesh erosion.Since february this year, had a worsening abdominal wound related to mesh erosion.Has been going to wound care; hasn¿t had improvement.Denies fever, has chronic nausea, had a lot of vomiting earlier this year; last vomited in march.Still takes ¿chemo therapy pills¿, afinitor; last intravenous chemo 2010.Last had radiation to back and rib.Radiation to ovaries in 2008.Says wound itself doesn¿t bother her, but wants surgery because since wound infection started in february, has had significant nausea, vomiting and diarrhea.Has 10-20 diarrhea bowel movements daily.Medical history: left breast cancer, chronic kidney disease, hypertension, high cholesterol, peripheral vascular disease, asthma, arthritis, stomach ulcer x2, chronic joint pain, hypothyroidism, breast cancer x2, mrsa, post-operative nausea/vomiting.Surgical history: bilateral mastectomy, abdominal debridement post mrsa after tram flap, cholecystectomy, skin graft abdomen, abdominal hernia repair with mesh, kidney surgery x2; stent, ureter re-routed, cesarean section x3.Medications: afinitor, aromasin, anaprox, prilosec, zofran-odt, oxycodone, phenergan.Smoking status: never smoker.Hospital course: tolerated procedure well.Was on regular diet as tolerated, had pain/nausea control as needed.Postoperative day 1, foley removed.Postoperative day 2, pca discontinued/transitioned to oral medications.Incisional wound vac placed postoperative day 3 evening due to increased serous drainage.Postoperative day 7, wound care nurse consulted; incisional vac discontinued and dry dressing applied.Labs and vitals were stable, pain controlled on oral medications; appropriate for discharge.Discharge medications: tylenol, colace, robaxin, ms contin, senokot.Disposition: home or self care.Condition: good.Activity: walk as tolerated, may shower, no lifting heavier than 5-10 lbs.; no strenuous activity for 6 weeks.Regular diet.Appointment (b)(6) 2017 with gi nurse.(b)(6) 2017: (b)(6).(b)(6), pac; (b)(6), md.Discharge summary.Admitted (b)(6) 2017.Presents as transfer from outside hospital with abdominal pain, nausea and vomiting.She is about 2 weeks status post explantation of infected abdominal wall mesh.Says since surgery, having clear drainage from midline, but it has increased over last couple days along with increased nausea and abdominal pain.Has not noticed erythema or purulent drainage.Denies fever or chills.Arrived with an x-ray of abdomen from the osh, which is unremarkable.Afebrile with normal wbc.Surgery was consulted for evaluation.Hospital course: admitted to gi surgery service and managed supportively with nothing by mouth, intravenous fluids, pain and nausea control.Diet advanced as tolerated.We worked on wound care while in hospital, drainage decreased with time.By (b)(6), she was tolerating diet and oral medications, labs and vitals were stable and deemed appropriate for discharge.Activity: walk as tolerated, may shower, no lifting heavier than 5-10 lbs., no strenuous activity for 6 weeks.Regular diet.Appointment (b)(6) 2017 with (b)(6), pa.(b)(6) 2017: (b)(6), md; (b)(6).Dnr comfort care.Dnrcc [checked].(if this box is checked the dnr comfort care protocol is activated immediately.) certification of dnr comfort care status (to be completed by the physician): do not resuscitate order [checked].(b)(6) 2017: (b)(6).Last will and testament.(b)(6) 2017: (b)(6) department of health ¿ vital statistics.Death certificate.Decedent¿s legal name: (b)(6).Sex: female.Date of death: (b)(6), 2017.Social security number: (b)(6).Age (years): 50.Date of birth: (b)(6), 1967.Birthplace city and state or foreign country: (b)(6) , ohio.Residence state: (b)(6) : summit.City or town: (b)(6).Street and number: (b)(6).Zip code: (b)(6).Inside city limits: no.Ever in us armed forces? no.Marital status at time of death: never married.Decedent¿s education: high school graduate or ged.Decedent of hispanic origin: no.Decedent¿s race: white.Father¿s name: (b)(6).Mother¿s name (prior to first marriage): (b)(6).Informant¿s name: (b)(6).Relationship to decedent: son.Mailing address: (b)(6).Place of death: hospital ¿ inpatient.Facility name: (b)(6) medical center.City or town, state and zip code: (b)(6).County of death: summit.Signature of funeral service licensee or other agent: (b)(6) license number (of licensee): (b)(6) name and complete address of funeral facility: (b)(6).Method of disposition: cremation.Date of disposition: (b)(6) 2017.Place of disposition: (b)(6).Location: (b)(6).Registrar¿s signature: (b)(6).Date filed: (b)(6) 2017.Name of person issuing disposition permit: (b)(6).District no: 7700.Date disposition permit issued: (b)(6) 2017.Certifier: certifying physician.To the best of my knowledge, death occurred at the time, date, and place and due to the causes and manner stated.Time of death: 0753.Date pronounced dead: (b)(6) 2017.Was the medical examiner or coroner contacted: no.Signature and title of certifier: (b)(6), do.License number: (b)(6) date signed: (b)(6) 2017.Name and address of person who certified cause of death: (b)(6).Part i: enter the disease, injuries, or complications that caused the death.Do not enter the mode of dying, such as cardiac or respiratory arrest, shock, or heart failure.List only one cause of death on each line.Immediate cause (final disease or condition resulting in death): a.Septic shock.Approximate interval between onset and death: hours.Part ii: other significant conditions contributing to death but not resulting in the underlying cause given in part i: metastatic breast carcinoma, atrial fibrillation.Was an autopsy performed? no.Were autopay findings available prior to completion of cause or death? not applicable.Did tobacco use contribute to death? no.Manner of death: natural.[signed] (b)(6), local registrar, (b)(6), 2019.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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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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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 warns: ¿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.¿ the instructions for use further warns: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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.Medical records that indicate mesh exposure may reflect abdominal wall wound dehiscence as a function of a patient¿s poor tissue quality or loss of anchorage of fixation or may be related to individual patient comorbidities, and technical and/or procedural aspects of the repair.These factors include, but are not limited to, fixation type, suture technique, type of and tension on the incision, and wound classification at time of procedure.Post-operative factors such as the development of a post-operative infection, an incision and drainage procedure, or wound packing could result in mesh exposure.Additionally, patient comorbidities that could influence wound dehiscence leading to mesh exposure include, but are not limited to, smoking and obesity.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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