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

Catalog Number BXA085901J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Death (1802)

Event Date 09/16/2020

Event Type  Death  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following was reported to gore: on (b)(6) 2020, the patient underwent endovascular procedure to treat chronic total occlusion (cto) of the left common iliac artery (cia) with kissing technique using two gore® viabahn® vbx balloon expandable endoprostheses.The procedure was successfully completed, and good blood flow was confirmed.The patient tolerated the procedure.On (b)(6) 2020, the patient presented with dull pain of abdominal area.Computed tomography (ct) suggested aneurysmal degeneration (mycotic aneurysm) around the endoprosthesis in the left cia (coded: aneurysm), and infection of the endoprosthesis was suspected.It was unknown which one of the two endoprostheses was involved in the suspected infection in the left cia.As it was considered the patient was high risk for surgery, the patient was being monitored in hospital with administration of antibiotics.On (b)(6) 2020, blood culture was positive.It was reported that causative agent was unknown.Also, the physician reportedly considered that there were some possible causes like intra-procedural manipulation or damage to the treatment area, and the cause or route of the infection was not able to be determined.On (b)(6) 2020, it was reported that the mycotic aneurysm ruptured.After ct confirmed the rupture with retroperitoneal bleeding, preparation of entering the operating room was being conducted, however, the patient expired.Reportedly, the cause of the death was bleeding due to the rupture of the mycotic aneurysm.It was also reported that the cause of the mycotic aneurysm was undeterminable.No autopsy was performed as the patient's family refused it.

Manufacturer Narrative

A review of the sterilization records for the device verified, that the lot met all pre-release specifications.

Manufacturer Narrative

H6 - added conclusion code.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10804972
• MDR Text Key: 215250481
• Report Number: 2017233-2020-01424
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2022
• Device Catalogue Number: BXA085901J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR