MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number VBH101002A

Device Problem Premature Activation (1484)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The following was reported to gore: the gore® viabahn® endoprosthesis started to deploy at the distal end and became stuck in the iliac artery.The physician used the appropriate sheath size to go up and over the bifurcation into the internal iliac artery.As reported, there was resistance during advancement, and the viabahn device started expanding from the distal end and got stuck.More information was requested but not made available.

Manufacturer Narrative

Event number was used for patient identifier.Date of event information was requested, but not made available by complainant.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8236908
• MDR Text Key: 133074009
• Report Number: 2017233-2019-00018
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623228
• UDI-Public: 00733132623228
• 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
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2019
• Device Catalogue Number: VBH101002A
• Device Lot Number: 15586763
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1