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

Catalog Number	BXA117902A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report refers to the second device mentioned in the description.The third device is being reported separately.A review of the manufacturing records 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 an iliac artery aneurysm with an unknown iliac branch device.A gore® viabahn® vbx balloon expandable endoprosthesis was intended to be placed in the internal iliac artery from an ipsilateral approach.The device was attempted to be advanced over a.035" rosen wire.Upon loading the device, outside the patient, the delivery catheter became accordioned.This device was discarded.The guidewire was exchanged for a.035" advantage wire.Another gore® viabahn® vbx balloon expandable endoprosthesis was advanced over the wire through a 14.5fr aptus tour guide sheath, through the iliac branch device, toward the internal iliac artery, however the device could not track over the tight turn of the anatomy.This device was attempted to be withdrawn but in doing so, the device came off the balloon catheter.A 4 mm balloon catheter was advanced through the device and inflated in order to anchor the stent and remove it from the patient.A third gore® viabahn® vbx balloon expandable endoprosthesis was advanced over the wire through the 14.5fr aptus tour guide sheath, through the iliac branch device, toward the internal iliac artery, however this device also could not track over the tight turn of the anatomy.While this device was attempted to be removed, the same thing happened and the device was retrieved in the same manner, by advancing a 4 mm balloon through and anchoring it to the balloon catheter for removal through the sheath.Finally a shorter length gore® viabahn® vbx balloon expandable endoprosthesis was advanced and deployed successfully, with 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: 8809919
• Report Number: 2017233-2019-00539
• Device Sequence Number: 320613
• Product Code: NIO
• UDI-Device Identifier: 00733132637768
• UDI-Public: 00733132637768
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2019

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: 05/11/2022
• Device Catalogue Number: BXA117902A
• Device Lot Number: 20690371
• 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: 07/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR