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

Catalog Number	BXA082901A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The following was reported to gore: patient presented for a frozen elephant trunk open procedure and a conformable gore® tag® thoracic endoprosthesis (ctag) was implanted.After implanting the ctag device, the physician cut a small hole in the ctag device with an 11 blade.The gore® viabahn® vbx balloon expandable endoprosthesis was then advanced into the fenestration, and into the left subclavian artery (lsa).As reported, the lsa was located very posterior and the lsa was described as tissue thin and very diseased.As the vbx device was advanced, the lsa was perforated.The vbx device was removed from the patient and discarded.The lsa was then ligated and a second ctag device was implanted to cover the ligated artery.The physician concluded that collateral vessels would continue to perfuse the artery.The patient was reported to be recovering well following the open procedure.
Additional Manufacturer Narrative
H6 - additional conclusion code selected.

• 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: 8692164
• Report Number: 2017233-2019-00409
• Device Sequence Number: 13954534
• Product Code: NIO
• UDI-Device Identifier: 00733132637546
• UDI-Public: 00733132637546
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 07/16/2019

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: 02/01/2022
• Device Catalogue Number: BXA082901A
• Device Lot Number: 20464361
• 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: 06/12/2019
• Supplement Report FDA Received Date: 07/22/2019
• 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