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

Catalog Number BXA077901J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Occlusion (1984)

Event Date 12/21/2019

Event Type  Injury  

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 conclusion can be drawn.All information has been placed on file for use in tracking and trending.

Event Description

On (b)(6) 2019, the patient underwent endovascular treatment for right common iliac artery-external iliac artery total occlusion.The wire was passed through the subintimal space.Since the lesion was spread near the terminal aorta, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was placed in the left common iliac artery and another vbx was placed in the right common iliac artery by kissing technique.Subsequently, a second vbx was additionally placed in the right external iliac artery.Both vbx were placed in the subintimal space.A bare-metal stent was placed in the external iliac artery-common femoral artery in the intima/true lumen.Blood flow was slightly confirmed at the final angiography.The right superficial femoral artery was originally occluded, and the deep femoral artery was poor flow but patent.On (b)(6) 2019, it was confirmed that the two vbx's on the right common iliac artery-external iliac artery were occluded.Endovascular treatment was performed.Catheter thrombolysis was performed for thrombus.The catheter treatment continued for 2 to 3 days.After confirmation of thrombolysis in the vbx, an additional stent was placed in the right superficial femoral artery.The procedure was completed confirming blood flow.The physician commented to gore that, in his opinion, the occlusion occurred because of poor run-off.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9746740
• MDR Text Key: 188387668
• Report Number: 2017233-2020-00127
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2022
• Device Catalogue Number: BXA077901J
• Device Lot Number: 20382456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Device Manufactured: 02/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention