MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number S0604

Device Problem Compatibility Problem (2960)

Patient Problems Seroma (2069); No Code Available (3191)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2020, a gore® propaten® vascular graft was placed as a arteriovenous graft (avg) for hemodialysis in the upper arm.After the device was implanted it was noticed that the patient developed swelling.The device was explanted at the time of the procedure.The physician suspected the graft had some hyperfiltration, due to proteinaceous peel, which caused the swelling.The patient tolerated the procedure.

• Brand Name: GORE-TEX STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10417771
• MDR Text Key: 203290005
• Report Number: 2017233-2020-01134
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132611294
• UDI-Public: 00733132611294
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903931
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S0604
• Device Catalogue Number: S0604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2019
• 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): Hospitalization; Other; Required Intervention