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

Catalog Number	SRD06005045L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that the lot met all pre-release specifications.As the device was not returned, no evaluation of the device could be performed.
Event or Problem Description
On (b)(6) 2019, the patient underwent a right femoral artery loop procedure with a gore-tex® stretch vascular graft - standard-walled fixed ringed.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.
Additional 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
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9211190
• Report Number: 2017233-2019-01049
• Device Sequence Number: 14239544
• Product Code: DSY
• UDI-Device Identifier: 00733132612260
• UDI-Public: 00733132612260
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K903931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2020
• Device Catalogue Number: SRD06005045L
• Device Lot Number: 14090695
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 69