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

Catalog Number VBH101002A

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2019

Event Type  malfunction  

Event Description

The following information was reported to gore: on (b)(6) 2019 a patient with a previously implanted medtronic endurant abdominal aortic device underwent treatment of a left iliac artery aneurysm.The intent was to extend the endurant device with gore® excluder® iliac branch endoprostheses, and more distally with a gore® viabahn® endoprosthesis.Following placement of the iliac branch components, the viabahn device was attempted to be advanced over a rosen from the right side in an up and over the flow divider of the endurant device to the internal iliac artery.However the device could not track all the way to the internal iliac artery, so it was withdrawn through the sheath.The wire was exchanged for an amplatz wire and advancement was attempted again, however the device still could not track to the desired location.Upon attempted removal the device seemed to be catching on something and additional force was applied to try to withdraw the device.This resulted in the device becoming separated from the delivery catheter.It is not known exactly where the device landed but it was secured in place with deployment of two gore® viabahn® vbx balloon expandable endoprostheses.The treatment was completed successfully with patency of all treated vasculature.

Manufacturer Narrative

D.10.Updated.H.6.Results code 2: 213: the engineering evaluation stated the following: the following observations were made: there was no endoprosthesis returned.The deployment knob does not appear to have been pulled from the hub and the deployment line is taut within the hub.The deployment line was coming out of the transition and was approximately 86 cm.There were kinks and stretching in the dual lumen catheter shaft at 58, 70, and 83 cm from the hub.Engineering evaluation conclusion is inconclusive as it relates to the event description.Based on the device examination performed, no manufacturing anomalies were identified.H.6.Conclusion code 1: updated.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8329852
• MDR Text Key: 138664299
• Report Number: 2017233-2019-00077
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2019
• Device Catalogue Number: VBH101002A
• Device Lot Number: 16188339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR