MAUDE Adverse Event Report: W.L. GORE & ASSOCIATE, INC. VIABAHN BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Model Number	BXAL087902A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was having surgery for endovascular thoracoabdominal aortic aneurysm repair when the stent pre-maturely separated from the delivery system.Surgeon able to retrieve undeployed stent completely.Fda safety report id# (b)(4).

• Brand Name: VIABAHN BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATE, INC.; flagstaff AZ 86004
• MDR Report Key: 12506868
• Report Number: MW5104100
• Device Sequence Number: 5159738
• Product Code: PRL
• UDI-Device Identifier: 00733132637676
• UDI-Public: (01)00733132637676
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/17/2021

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 Model Number: BXAL087902A
• Device Catalogue Number: BXAL087902A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2021
• 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: Other
• Patient Age: 46 YR
• Patient Weight: 71