MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® ENDOPROSTHESIS; NIP

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Information (3190)

Event Date 03/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device lot number information was requested but not supplied; therefore, no review of the manufacturing paperwork could be performed.The abstract did not indicate device was explanted; therefore, conclusion is device remains implanted.Product analysis could not be performed.

Event Description

Reviewed was, viabahn stent-graft placement for emergent/ urgent cervical cerebrovascular artery disease: a single-center experience of 22 cases.Presented at the 43rd annual scientific meeting of society of interventional radiology (sir); march 17-22, 2018; los angeles, ca.Journal of vascular & interventional radiology 2018;29(4)supplement: s187.Abstract no.441.Authors: horikawa m, petersen b, bozorgchami h, liu j, priest r.The abstract refers to a retrospective study using gore® viabahn® endoprostheses and the devices were utilized in emergent/urgent cervical cerebrovascular artery disease cases, from january 2003 to september 2017.Viabahn devices were used for acute bleeding or pseudoaneurysms of innominate, cervical carotid, or vertebral artery in emergent/urgent clinical conditions in 22 patients.In this updated abstract of a poster presentation, it was stated that one patient underwent subsequent bypass surgery within 17 days due to suspected infection.Further information was not provided.

Manufacturer Narrative

Correction was made to event date.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7508386
• MDR Text Key: 108089348
• Report Number: 2017233-2018-00275
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention