MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT; MESH, SURGICAL

Device Problems Fluid/Blood Leak (1250); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

According to the gore® seamguard® bioabsorbable staple line reinforcement instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: infection, inflammation, adhesion and hematoma.

Event Description

The following publication which mentions gore® seamguard® bioabsorbable staple line reinforcement was reviewed: bioabsorbable staple line reinforcement in restorative proctectomy and anterior resection: a randomized study.Background: anastomotic complications, including leaks, strictures/stenosis, and bleeding, cause considerable mortality and morbidity after colorectal surgery.Methods: this study was conducted at 17 centers in the united states.The 258 patients 123 in the reinforcement group (gore® seamguard® circular bioabsorbable staple line reinforcement) and 135 control subjects underwent surgery for a variety of conditions, but most (n = 200) were treated for rectal cancer.A double-stapled, circular-stapler anastomosis was performed in all of the patients.The diameter of the circular stapler (28 to 34 mm) was determined by the operating surgeon in each case.Results: one patient in the bslr group experienced stenosis (stricture) requiring a re-intervention.

• Brand Name: GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT
• Type of Device: MESH, SURGICAL
• 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: 10248945
• MDR Text Key: 198089393
• Report Number: 3003910212-2020-01004
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2020

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/09/2020
• 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 Age: 54