MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE DUALMESH® BIOMATERIAL; MESH, SURGICAL, POLYMERIC

Model Number	1DLMC09
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Information (3190); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).It should be noted that the instructions for gore® dualmesh® biomaterial use includes 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.¿.
Event or Problem Description
It was reported to gore that the patient underwent laparoscopic umbilical hernia repair on (b)(6) 2009, whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on "to be supplemented" an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: "to be supplemented".Additional event specific information was not provided.
Additional Manufacturer Narrative
Updated results code.Conclusion code remains unchanged.
Additional Manufacturer Narrative
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: on (b)(6) 2009: (b)(6), md.Operative report.Assistant: (b)(6), md, facs.Preoperative diagnosis: umbilical hernia.Postoperative diagnosis: umbilical hernia.Procedure: laparoscopic umbilical hernia.Anesthesia: general.Estimated blood loss: minimal.Iv fluids: see anesthesia record.Drains: none.Complications: none.Indications: the patient is a 46-year-old male who presented with a symptomatic umbilical hernia __ [sic] transplant as well as __ [sic] kidney disease__ [sic] fascial defect.Description of procedure: ¿the patient was brought to the operating room and placed supine on the table.General anesthesia was induced and maintained with adequate anesthesia.Orogastric tube and a foley catheter were placed.The abdomen was prepped and draped in a sterile fashion.Lidocaine mixture was used throughout for adjuvant anesthesia.Periumbilical incision was made and carried down through the subcutaneous tissue.The hernia sac was opened to expose the fascial defect.A vicryl stay suture was placed.A hasson cannula was placed in intraperitoneal cavity under direct vision.A pneumoperitoneum was created.Under direct vision, a 5-mm port was placed in the left upper quadrant and left lower quadrant.The fascial defect was identified and incised.It was elected that a 12-cm circular __ [sic] patch was utilized for repair.__ [sic] patch it appeared that the falciform ligament was in the way of superior aspect.Using electrocautery the falciform ligament was taken down.Patch was repaired with 0 gore-tex sutures in four quadrants.It was rolled and placed intraperitoneally.It was then unrolled and then using a percutaneous approach the four cardinal sutures were placed transfascially and was completed.Once that had been done, circumferential packed with a permasorb-type absorbable tack.No bleeding was identified.Patch was in good position.__ [sic] was removed under direct vision.No bleeding was seen.The pneumoperitoneum was released.The myofascial at the umbilicus was closed with 0-vicryl suture.The skin was closed with 4-0 monocryl subcuticularly.All the other incisions were closed with 4-0 monocryl subcuticularly as well.Histocryl was applied.The procedure was completed.The patient tolerated well and brought to the recovery in stable condition.¿ on (b)(6) 2009: (b)(6) hospitals.Implant sticker.Gore dualmesh® biomaterial.Ref catalogue number: 1dlmc09.Lot batch code: 06298544.W.L.Gore & associates.The records confirm a gore® dualmesh® biomaterial (1dlmc09/06298544) was implanted during the 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 instructions for gore® dualmesh® biomaterial use includes 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.¿ 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.
Additional Manufacturer Narrative
H6: updated health effect.H6: updated investigation finding.H6: updated investigation conclusions: d15: cause not established; d17: appropriate code/term not available for ¿withdrawn¿ complaint¿.H6: health effect impact code: f24: insufficient information.H6: medical device component: g04088: membrane.This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.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.No further investigation is required at this time.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as insufficient information and no findings available and will be closed as withdrawn¿ and ¿cause not established¿.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.It should be noted that the gore® dualmesh® 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.The status of the device is unknown as no record of explant was provided.Review of the manufacturing records verified that the lot met all pre-release specifications.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.

• Brand Name: GORE DUALMESH® BIOMATERIAL
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: rena gros ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9213539
• Report Number: 3003910212-2019-00427
• Device Sequence Number: 16765089
• Product Code: FTL
• UDI-Device Identifier: 00733132601028
• UDI-Public: 00733132601028
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K992189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2013
• Device Model Number: 1DLMC09
• Device Catalogue Number: 1DLMC09
• Device Lot Number: 06298544
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 11/05/2019; 12/19/2019; 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male