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

Model Number	HAX01A
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.(b)(4).The explanted graft was not returned / retained at user facility.Therefore, direct product analysis was not possible.
Event or Problem Description
On (b)(6) 2020, an gore® propaten® vascular graft (standard wall removable rings ax-bifem) was implanted due to aorta-iliac occlusive disease.On (b)(6) 2020, the graft was explanted because of a reported graft infection.The patient was diagnosed with mrsa sometime after the vascular graft was implanted.The patient was reported to be recovering well after the explant procedure.The explanted graft was discarded and a section of the graft was sent for testing at the user facility.
Additional Manufacturer Narrative
H6 - code 213: review of device sterilization record history confirmed device met pre-release specifications.
Additional Manufacturer Narrative
G4: pma/510(k) number was corrected.
Additional Manufacturer Narrative
E1: patient's street address was added.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10538881
• Report Number: 2017233-2020-01267
• Device Sequence Number: 11540805
• Product Code: DSY
• UDI-Device Identifier: 00733132617715
• UDI-Public: 00733132617715
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/13/2020

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: 12/15/2023
• Device Model Number: HAX01A
• Device Catalogue Number: HAX01A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 08/19/2020; 08/19/2020; 08/19/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/14/2020; 11/07/2020; 11/13/2020
• 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: 82 YR
• Patient Weight: 50