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

Model Number FS0915

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Seroma (2069)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Contraindications: the gore® bio-a® tissue reinforcement is contraindicated for use in reconstruction of cardiovascular defects.Because gore® bio-a® tissue reinforcement is absorbable, it is contraindicated for use in patients requiring permanent support from the device.The instructions for use (ifu) for the gore® bio-a® tissue reinforcement state: possible adverse events with the use of any tissue deficiency prosthesis or soft tissue reinforcement surgical procedures may include, but are not limited to, additional intervention including surgery, adhesions and related harms, bowel obstruction, defect recurrence and related harms, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, infection, irritation or inflammation, pain, paresthesia, seroma or hematoma and related harms, tissue ischemia, and wound dehiscence.As with any mesh, use of gore® bio-a® tissue reinforcement in the presence of contamination may result in fever, infection, irritation or inflammation, pain, and wound dehiscence, and may require removal of the mesh if infection occurs.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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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.

Event Description

It was reported by the field sales associate that the physician used the gore® bio-a® tissue reinforcement for a breast reconstruction procedure.Reportedly, the patient experienced seroma and infection.It was reported the physician removed the device due to the infection.Reportedly, the patient is doing well according to the follow ups.Reportedly, the device was explanted 3 weeks after intervention and was removed via skin incision.It was reported the infection was treated with antibiotics and the mesh was removed.Reportedly, there was a wound dehiscence and there were drains placed during the procedure.It was reported the seroma was aspirated.Drained and the device was placed next to well vascularized tissue on both sides.

• Brand Name: GORE® BIO-A® TISSUE REINFORCEMENT
• Type of Device: 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: angela brown ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14680195
• MDR Text Key: 294910778
• Report Number: 3003910212-2022-01376
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00733132605422
• UDI-Public: 00733132605422
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K033671
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2023
• Device Model Number: FS0915
• Device Catalogue Number: FS0915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/13/2022
• Date Device Manufactured: 04/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization