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

Catalog Number BXA077901J

Device Problem Collapse (1099)

Patient Problem Occlusion (1984)

Event Date 02/01/2019

Event Type  Injury  

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.

Event Description

The following was reported to gore: on (b)(6) 2018, the patient underwent an endovascular repair using a gore® viabahn® vbx balloon expandable endoprosthesis to repair occlusive disease in the left iliac artery (from near origin of the left iliac artery to the left external iliac artery).The patient tolerated the procedure.On an unknown date in (b)(6) 2019, a follow-up imaging identified compression and occlusion of the endoprosthesis.On (b)(6) 2019, the physician performed a bypass procedure.The patient tolerated the procedure.

• 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: 8417559
• MDR Text Key: 138693452
• Report Number: 2017233-2019-00141
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: BXA077901J
• Device Lot Number: 18482280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2018
• 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