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

Model Number	BXA073902A
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	05/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2020, the patient presented with a thoracoabdominal aortic aneurysm (taaa) class iv that was successfully treated with a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) and gore viabahn® vbx balloon expandable endoprostheses that were used as side branch components.On (b)(6) 2020, celiac branch and superior mesenteric artery (sma) branch stenosis was identified.On (b)(6) 2020, additional stents were implanted in the sma and celiac artery.Additionally balloon angioplasty was done.The procedure was successfully completed and both arteries patent.
Additional Manufacturer Narrative
Code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications.

• 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: 10199681
• Report Number: 2017233-2020-00453
• Device Sequence Number: 2613543
• Product Code: NIO
• UDI-Device Identifier: 00733132637270
• UDI-Public: 00733132637270
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: 10/08/2022
• Device Model Number: BXA073902A
• Device Catalogue Number: BXA073902A
• Device Lot Number: 21754428
• Was Device Available for Evaluation?: No
• 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: 06/26/2020
• Supplement Report FDA Received Date: 06/14/2021
• 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: 86 YR