MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC

Catalog Number	BXA085902A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2019 a patient was undergoing treatment of a stenotic occlusion of the left common iliac artery with a gore® viabahn® vbx balloon expandable endoprosthesis.The device was advanced over a.035" wire through a 7fr sheath.While tracking though the iliac artery the stent came off the balloon catheter.It was in an acceptable location, so the stent was ballooned where it landed.There were no adverse outcomes for the patient.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8450278
• Report Number: 2017233-2019-00173
• Device Sequence Number: 3013753
• Product Code: NIO
• UDI-Device Identifier: 00733132637331
• UDI-Public: 00733132637331
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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: 06/12/2021
• Device Catalogue Number: BXA085902A
• Device Lot Number: 18342407
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR