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

Device Problem Insufficient Information (3190)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/17/2015

Event Type  Injury  

Manufacturer Narrative

Patient identifier was not disclosed.(b)(4).

Event Description

It was reported to gore that a patient presented for a roux-en-y gastric bypass in (b)(6) 2015.Eleven days post implant the patient returned with a bowel obstruction.The doctor observed a piece of the endoscopic gore seamguard bioabsorbable staple line reinforcement at the stricture and believes the endoscopic gore seamguard bioabsorbable staple line reinforcement caused the stricture.The doctor preformed a bowel resection and the patient is reported to be doing well.

• Brand Name: GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
• 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: cheryl hawke ; 301 airport rd.; elkton, MD ; 9285263030
• MDR Report Key: 5552067
• MDR Text Key: 42006912
• Report Number: 3003910212-2016-00020
• 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
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2016

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2016
• 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: 53 YR
• Patient Weight: 168