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

Catalog Number	VBH101002A
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.
Additional 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
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8236908
• Report Number: 2017233-2019-00018
• Device Sequence Number: 11000385
• Product Code: PFV
• UDI-Device Identifier: 00733132623228
• UDI-Public: 00733132623228
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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: 07/12/2019
• Device Catalogue Number: VBH101002A
• Device Lot Number: 15586763
• 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: 01/10/2019
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1