MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number SRD06005045L

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that the lot met all pre-release specifications.As the devices were not returned, no evaluation of the devices could be performed.

Event Description

On (b)(6) 2019, the patient was implanted with a gore-tex® stretch vascular graft - standard-walled fixed ringed in their right femoral artery.The device was reportedly used for the application of av access.It is unknown if the device was pre-cannulated for av access.There was reportedly no pre-existing infection at implant site.On (b)(6) 2019, the device was reportedly explanted due to infection.The physician reportedly stated it is unknown if the cause of the infection is attributed to the gore device.

Manufacturer Narrative

H6: code 213 ¿ the review of the sterilization paperwork verified that the lot met all pre-release specifications.

• Brand Name: GORE-TEX STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9210759
• MDR Text Key: 163022061
• Report Number: 2017233-2019-01047
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132612260
• UDI-Public: 00733132612260
• Combination Product (y/n): N
• PMA/PMN Number: K903931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2024
• Device Catalogue Number: SRD06005045L
• Device Lot Number: 20166279
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 92