MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® BIO-A® TISSUE REINFORCEMENT; MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY

Catalog Number FS2030E

Device Problem Insufficient Information (3190)

Patient Problem Seroma (2069)

Event Date 05/17/2023

Event Type  Injury  

Manufacturer Narrative

Per the gore® bio-a® tissue reinforcement instructions for use (ifu) 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 and seroma.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 to gore that a surgeon reported a seroma with a gore® bio-a® tissue reinforcement.It was further reported that a fs2030e gore® bio-a® tissue reinforcement was implanted last year.It was a ventral hernia repair and the implanting surgeon believes there was a seroma a few weeks later.The doctor put drains in and said they were removed too early.A breast surgeon later removed the mesh and the implanting surgeon said the breast surgeon should not have removed the device.There was no further information given.The lot number and patient information was not recalled by the surgeon and he stated he was not concerned about the event.It is unknown where the device is and so it is unavailable for return.

Manufacturer Narrative

H6 component code: corrected to g04053.

Manufacturer Narrative

Section g3 / g4 pma/510(k)number: corrected pma/510(k)number.

• Brand Name: GORE® BIO-A® TISSUE REINFORCEMENT
• Type of Device: MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
• 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: megan reigh ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17148633
• MDR Text Key: 317446297
• Report Number: 3003910212-2023-01467
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FS2030E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female