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

Catalog Number VBJR061002A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2018

Event Type  malfunction  

Event Description

The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of unknown type and anatomical location with a gore® viabahn® endoprosthesis.When deployment was attempted, the proximal end of the stent would not expand.The delivery catheter was then pulled back and the stent came back with it.The delivery catheter then separated from the stent and then the stent deployed.A second stent was needed to bridge to the first one, and the procedure was concluded.

Manufacturer Narrative

Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

Manufacturer Narrative

H.6.Results code 2: 213: the engineering evaluation stated the following: the following observations were made: the endoprosthesis was not returned.There was approximately 178 cm of deployment line returned attached to the deployment knob.The deployment line, deployment knob, and delivery catheter were unremarkable.Engineering evaluation conclusion is inconclusive as it relates to the event description.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7947558
• MDR Text Key: 124974893
• Report Number: 2017233-2018-00601
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623969
• UDI-Public: 00733132623969
• 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,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2021
• Device Catalogue Number: VBJR061002A
• Device Lot Number: 18166089
• 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