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

Catalog Number BXA077901J

Device Problems Partial Blockage (1065); Collapse (1099)

Patient Problem Occlusion (1984)

Event Date 04/05/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.See medwatch #2017233-2019-00336 regarding 2nd device.

Event Description

On (b)(6) 2019, the patient underwent endovascular procedure using two gore® viabahn® vbx balloon expandable endoprostheses to repair occlusion of the bilateral common iliac arteries.It was reported that the common iliac arteries were highly calcified, and that the devices were implanted by kissing stent technique with no issues.The patient tolerated the procedure.On (b)(6) 2019, a post-operative follow-up imaging revealed that both devices were compressed distally with the devices almost occluded.The physician reported that manual massage on lower abdomen might have attributed to the device compression.On (b)(6) 2019, poba was performed to repair the compression with no reported issues.The patient tolerated the re-intervention.

Manufacturer Narrative

Additional 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.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.Corrected data: results code 1.Conclusion code 1.

Manufacturer Narrative

Corrected data: date of event.

Manufacturer Narrative

Corrected data: date of event.

• 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: 8597831
• MDR Text Key: 144668585
• Report Number: 2017233-2019-00335
• Device Sequence Number: 1
• Product Code: NIO
• 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,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2021
• Device Catalogue Number: BXA077901J
• Device Lot Number: 20029291
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR