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

Model Number BXA095902A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

Additional 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.Concomitant medical products: as it is not known which device or both were involved in this case, the following additional device is being investigated as part of this report: bxa095902a, sn: (b)(4), udi: (b)(4).

Event Description

The following was reported to gore: on (b)(6) 2019 a patient underwent thoraco-abdominal aneurysm treatment as a subject in the (b)(6) clinical trial.Gore¿ viabahn¿ vbx balloon expandable endoprostheses were utilized in the sma.On (b)(6) 2019 a type ic endoleak was discovered in the sma.On (b)(6) 2021 the type ic endoleak was treated by means of balloon angioplasty and placement of a peripheral stent graft.The patient tolerated the procedure.

Manufacturer Narrative

This incident was previously reported under 2017233-2021-02315.Therefore this report is being retracted.

• 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: 12362537
• MDR Text Key: 267967714
• Report Number: 2017233-2021-02305
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637379
• UDI-Public: 00733132637379
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2022
• Device Model Number: BXA095902A
• Device Catalogue Number: BXA095902A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H.10./11.
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 81