MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC

Catalog Number BXAL083902A

Device Problem Premature Separation (4045)

Patient Problem Occlusion (1984)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The following was reported to gore: the gore® viabahn® vbx balloon expandable endoprosthesis came off of the balloon catheter in the common iliac during attempted removal to re-balloon the targeted area (left iliac).The doctor reported the patient is fine.

Manufacturer Narrative

Corrected data: event description.Additional manufacturer narrative: supplemental 2 makes reference to a 'corrected date'.There is no 'corrected date' to be entered.

Event Description

The following was reported to gore by the doctor: the gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was advanced through a 7fr pinnacle® sheath.The doctor reported the vbx catheter was tight and snug initially through the hub of the sheath.The vbx was advanced to the lesion and met resistance.The doctor elected to pull the vbx back and balloon.Pulling the catheter back away from the lesion the doctor observed the vbx detached from the catheter.The doctor continued to pull the catheter out, rewired with a smaller balloon, advance the smaller balloon into the vbx, and inflate deploying the vbx.There was no harm to the patient.

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records indicated the device met pre-release specifications.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8474669
• MDR Text Key: 140665261
• Report Number: 2017233-2019-00202
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00733132637829
• UDI-Public: 00733132637829
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• 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: 05/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2021
• Device Catalogue Number: BXAL083902A
• Device Lot Number: 20017763
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/10/2019; 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR