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

Catalog Number	BXA083902A
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	09/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 7fr ansel sheath,.035" stiff amplatz wire, snare.A review of the manufacturing records indicated that the device met pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of a right common iliac artery lesion with a gore® viabahn® vbx balloon expandable endoprosthesis.Access was obtained from the left groin with a 7fr ansel sheath over a stiff.035" amplatz wire.The device was attempted to be advanced in an up and over the aortic bifurcation fashion, but it could not be advanced past the left common iliac artery.The device was removed through the sheath.Wire access was preserved.The sheath was exchanged for a shorter (10cm) 8fr sheath, and the device was advanced, but became stuck in the left common iliac artery.The device was attempted to be withdrawn through the sheath, however the undeployed stent became separated from the balloon catheter, landing in the left common iliac artery.The balloon catheter was removed and a snare was advanced to capture the stent, which was successful.A decision was made to postpone this treatment.On (b)(6) 2018 the patient was treated successfully.

• 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: 7887499
• Report Number: 2017233-2018-00562
• Device Sequence Number: 13509946
• Product Code: NIO
• UDI-Device Identifier: 00733132637317
• UDI-Public: 00733132637317
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/13/2018

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: 04/15/2021
• Device Catalogue Number: BXA083902A
• Device Lot Number: 18130911
• 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: 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: 48 YR