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

Catalog Number	BXAL085901A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/30/2018
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) 2018 a patient was undergoing treatment of an abdominal aortic aneurysm.A gore® viabahn® vbx balloon expandable endoprosthesis was being utilized in one of the iliac arteries.The device was loaded onto a.035" wire and passed through an 8fr.Sheath, however this maneuver required high force.The device was deployed in the desired location, but when the delivery system was being removed, the delivery catheter became separated from the hub, while in the sheath, inside the body.All of the delivery system components were successfully removed from the patient, with no injury.The patient did well following the procedure.
Additional Manufacturer Narrative
Results code 2: 213: the engineering evaluation stated the following: the device was identified as an 8l x 59 x 800 (mm) configuration, which matches the event description.The device was received deployed.Catheter damage was observed 14 cm from the end of the end of the catheter where the hub was connected.The hub and the catheter were received separate.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• 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: 7852182
• Report Number: 2017233-2018-00544
• Device Sequence Number: 16647377
• Product Code: NIO
• UDI-Device Identifier: 00733132637836
• UDI-Public: 00733132637836
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

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: 04/11/2021
• Device Catalogue Number: BXAL085901A
• Device Lot Number: 18110608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• 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: 09/06/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR