MAUDE Adverse Event Report: GORE GORE VIABAHN; ENDOVASCULAR PROSTHESIS

Catalog Number	VBJR072502A
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/02/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Stent-graft would not deploy.

• Brand Name: GORE VIABAHN
• Common Device Name: ENDOVASCULAR PROSTHESIS
• Manufacturer (Section D): GORE; flagstaff AZ 86003
• MDR Report Key: 5865507
• Report Number: MW5063977
• Device Sequence Number: 10830471
• Product Code: NIP
• UDI-Device Identifier: 00733132623792
• UDI-Public: (01)00733132623792
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/05/2016

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: 04/29/2019
• Device Catalogue Number: VBJR072502A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 160