MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® BIO-A® TISSUE REINFORCEMENT; MESH, SURGICAL, POLYMERIC

Model Number	FS2020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It should be noted that the gore® bio-a® tissue reinforcement  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® bio-a® tissue reinforcement 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.".
Event or Problem Description
It was reported to gore that the patient underwent incisional hernia repair on (b)(6) 2012 whereby a gore® bio-a® tissue reinforcement was implanted.The complaint alleges that on (b)(6) 2013, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection, adhesions.Hernia recurrence, and bowel removal.Additional event specific information was not provided.
Additional Manufacturer Narrative
The gore® bio-a® tissue reinforcement device was included in the original complaint and was reported.Upon further investigation the medical records indicate that the device was not implanted on (b)(6), 2012.The medical records state: "mesh bio-a fit sheet 20 x 20 cm.Serial/lot #; (b)(6).Model no.Fs2020.Total implanted: 0.Total wasted: 1" during the implant, two devices were noted, but one was not used and was wasted.
Additional Manufacturer Narrative
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.No further investigation is required at this time.Through 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 no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as false claim and no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.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® bio-a® tissue reinforcement 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 states: ¿the implanted gore® bio-a® tissue reinforcement is a porous fibrous structure composed solely of synthetic bioabsorbable poly(glycolide: trimethylene carbonate) copolymer.Degraded via a combination of hydrolytic and enzymatic pathways, the copolymer has been found to be both biocompatible and nonantigenic.In vivo studies with this copolymer indicate the bioabsorption process should be complete by six to seven months.¿ therefore, this gore device would not be expected to contribute to infection, hernia recurrence and explant, beyond this timeframe.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without bio-a.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, migration, 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.Based upon the information received, the device was not available for evaluation.Review of the manufacturing and sterilization 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® BIO-A® TISSUE REINFORCEMENT
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12093950
• Report Number: 3003910212-2021-01257
• Device Sequence Number: 3564756
• Product Code: FTL
• UDI-Device Identifier: 00733132605446
• UDI-Public: 00733132605446
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2024

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: 10/31/2013
• Device Model Number: FS2020
• Device Catalogue Number: FS2020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 06/29/2021; 06/29/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/16/2021; 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2010
• 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: 36 YR
• Patient Sex: Male