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

Catalog Number 1BSGC25

Device Problem Leak/Splash (1354)

Patient Problem Failure to Anastomose (1028)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4)- the review of the manufacturing paperwork verified that this lot met all pre-release specifications.The device remains implanted.Per the physician, he did not believe the device caused the leak.

Event Description

It was reported to gore that a patient underwent a colon resection on (b)(6) 2016 using gore® seamguard® bioabsorbable staple line reinforcement.The surgeon reported that on (b)(6) 2016 the patient developed an anastomotic leak and underwent surgery and was fitted with a colostomy bag.

Manufacturer Narrative

(b)(4).

• 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: 6080279
• MDR Text Key: 59222037
• Report Number: 3003910212-2016-00064
• 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
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 1BSGC25
• Device Lot Number: 14916761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2016
• 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