MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS; PFV / NIP

Model Number	VBCR080501A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2020, a gore® viabahn® endoprosthesis (vsx) was to be placed for treatment of a failed fistula in the brachial artery.However, when the physician was deploying the device it partially expanded then stopped.The physician was not able to fully deploy the device and removed the device and sheath in tandem.An additional vsx was successfully deployed to complete the procedure.The patient tolerated the procedure and is doing well.
Additional Manufacturer Narrative
G4 - updated with pma/510(k) number (p040037).C1, correction - in manufacturer report number, 2017233-2020-01095, the device is identified as a cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.This device in not coated with a heparin bioactive surface.
Additional Manufacturer Narrative
The following observations were made: the delivery catheter was returned not the device.The dual lumen was kinked 14.5 and 65 cm from the hub.The remainder of the delivery catheter was unremarkable.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS
• Common Device Name: PFV / NIP
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10375878
• Report Number: 2017233-2020-01095
• Device Sequence Number: 2004671
• Product Code: PFV
• UDI-Device Identifier: 00733132623501
• UDI-Public: 00733132623501
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: VBCR080501A
• Device Catalogue Number: VBCR080501A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 02/11/2021; 02/24/2021
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 02/11/2021; 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR