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

Catalog Number	BXAL087902A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product(s): a gore® viabahn® vbx balloon expandable endoprosthesis was also implanted in same location.It is unknown which device occluded.Lot number for second device is 17964884; udi number (b)(4).A review of the manufacturing records verified that both device lots involved in this event met all pre-release specifications.
Event or Problem Description
The following was reported to gore: on (b)(6) 2018, the patient underwent endovascular treatment for an infrarenal aortic aneurysm using a gore® excluder® iliac branch endoprosthesis.Two gore® viabahn® vbx balloon expandable endoprostheses were also implanted in the left common iliac artery.On (b)(6) 2018, one of the vbx device was found to be occluded.A fem-fem bypass procedure was performed was performed and perfusion was restored.It was reported the patient tolerated the procedure.

• 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: 7717066
• Report Number: 2017233-2018-00433
• Device Sequence Number: 1452064
• Product Code: NIO
• UDI-Device Identifier: 00733132637676
• UDI-Public: 00733132637676
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2021
• Device Catalogue Number: BXAL087902A
• Device Lot Number: 17964878
• 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: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 68