MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES CIRCULAR BIOABSORBABLE SEAMGUARD 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, adhesions 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: five patients in each group were found to have an anastomotic air leak at the time of surgery. Three of the leaks in each group required repair; the other 2 did not.

• Brand Name: CIRCULAR BIOABSORBABLE SEAMGUARD
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: angela brown ; 1500 n. 4th street; 9285263030
• MDR Report Key: 10248903
• MDR Text Key: 198089836
• Report Number: 3003910212-2020-00117
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• 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 Treatment Data

Date Received: 07/09/2020 Patient Sequence Number: 1