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

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 06/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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: a multicenter randomized controlled trial comparing pancreatic leaks after tissuelink versus seamguard after distal pancreatectomy (plats) nct01051856. Background: pancreatic leak is common after distal pancreatectomy. This trial sought to compare tissuelink closure of the pancreatic stump to that of seamguard. Methods: a multicenter, prospective, trial of patients undergoing distal pancreatectomy randomized to either tissuelink or seamguard. Results: overall, 67 patients were enrolled, 35 tissuelink and 32 seamguard. Overall, 37 of 67 patients (55%) experienced a leak of any grade, 15 (46. 9%) in the seamguard arm and 22 (62. 9%) in the tissuelink arm (p ¼ 0. 19). The trial enrolled patients from january 2010 to march 2014, inclusive. Overall, 58. 2% of patients were female. Median age for the overall cohort was 57 yrs. Fifteen patients experienced leaks, while 4 required a percutaneous drain in the seamguard group.

• Brand Name: ENDOSCOPIC GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT
• 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: 10241620
• MDR Text Key: 197847087
• Report Number: 3003910212-2020-00112
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043056
• 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: 07/07/2020
• 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?: No Answer Provided
• 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: 07/07/2020 Patient Sequence Number: 1