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

Catalog Number FS2020E

Device Problem Material Disintegration (1177)

Patient Problem Bowel Perforation (2668)

Event Date 07/25/2022

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.(b)(4).This event is also reported with gore (b)(4) number (manufacturer report number 3003910212-2022-01390) for the second gore® bio-a® tissue reinforcement.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 that two gore® bio-a® tissue reinforcement was implanted on (b)(6) 2022 for an abdominal wall reconstruction with ileostomy.It was a complex procedure due to the size of the hernia and the fact that a loop of bowel was diverted through an artificial opening in the abdominal wall.A sandwich technique was used where the gore® bio-a® tissue reinforcement was laid on the peritoneum with a prolene® soft polypropylene mesh (ethicon) on top.Patient was septic one week after the procedure.On (b)(6) 2022, the patient underwent a reintervention where both the gore® bio-a® tissue reinforcement and the prolene® soft polypropylene mesh was explanted.The ileostomy perforation had filled the retrorectus space in small bowel content; but there was no intraperitoneal contamination.The gore® bio-a® tissue reinforcement was reportedly in fragments.On (b)(6) 2022, a new gore® bio-a® tissue reinforcement was implanted in the patient and by the end of the procedure the abdominal wall looked well.It was reported that it is unknown why bowel contents was found in the rectrorectus space after the original procedure it could be multifactorial.It could have been down to bowel injury or it could be mesh erosion unlikely to be from the gore® bio-a® tissue reinforcement.The patient stayed in the intensive care and received percutaneous drainage of the retrorectus space (serous culture was tested negative).The patient failure to progress and expired due to respiratory failure on (b)(6) 2022.

Manufacturer Narrative

H6: updated investigation findings code to c19 - no device problem found.Code 3233 is no longer applicable.Updated investigation conclusions code to d15 and d10.Code 11 is no longer applicable.Manufacturing and packaging documents were reviewed and device was processed per sop and met all processing and product specification requirements.This event is reported due to device explantation, the cause is unlikely to be from the gore® bio-a® tissue reinforcement.

Manufacturer Narrative

B2: changed outcomes attributed to adverse event to "other serious (important medical events)".H1: changed type of reportable event to "serious injury".H6: removed health effect - impact code 1802.Upon investigation conclusion, the gore device is being reported as a serious injury due to reintervention.The patient expired however per our investigation it was unrelated to the gore device.

Manufacturer Narrative

Added code b11.

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15181780
• MDR Text Key: 297403820
• Report Number: 3003910212-2022-01391
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033671
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2023
• Device Catalogue Number: FS2020E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2020
• 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; Death
• Patient Age: 71 YR
• Patient Sex: Male