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

Catalog Number VBJR051002A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.

Event Description

The following was reported to gore: the hospital reported that a gore® viabahn® endoprosthesis deployment line broke during deployment.

Manufacturer Narrative

Additional manufacturer narrative: h6.Method code 2.H6.Results code 2.The reported event could not be confirmed because the device was not returned.Based on the engineer evaluation of the information obtained during the investigation, no product design or manufacturing anomalies were detected.Corrected data: h6.Conclusions code 1.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9180580
• MDR Text Key: 166778950
• Report Number: 2017233-2019-01011
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623914
• UDI-Public: 00733132623914
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: VBJR051002A
• Device Lot Number: 20734287
• 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