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

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

The date of the reintervention, (b)(6) 2020, was chosen as the date of event as a best estimate.(b)(4).The serial number of the device is yet unknown and the device remains implanted in the patient.Therefore no evaluation could be performed yet.The serial number was requested from the physician.Answer pending.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

A few week ago, on unknown exact date, the patient underwent a staged branched endovascular aortic repair procedure with zenith® t-branch® thoracoabdominal endovascular graft (cook medical).All bridging stents to the visceral vessels were gore® viabahn® vbx balloon expandable endoprostheses (viabahn vbx device).The celiac artery was not stented during initial procedure, to allow collateral vessels in lumbar region to develop and perfuse.On (b)(6) 2020, the second intervention to treat the celiac artery with a viabahn vbx device was done successfully.On (b)(6) 2020, an endovascular reintervention was required because of a type 1c endoleak from the viabahn vbx device placed in the superior mesenteric artery.The physician suspected, that the endoleak developed because of undersizing during the initial procedure.They extended the sealing zone with a viabahn vbx device, tracking from the femoral artery over an amplatz wire, through an aptus 16f sheath (medtronic), to treat the endoleak successfully.It was stated, that the patient is doing fine.

Manufacturer Narrative

H6-conclusion code: correction: the user stated that they were undersizing the device during the initial procedure.Therefore the root cause may be traced to the user.

• 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: 10440565
• MDR Text Key: 204003025
• Report Number: 2017233-2020-01145
• 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
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/23/2020
• Supplement Dates Manufacturer Received: 10/16/2020; 01/08/2021
• Supplement Dates FDA Received: 11/06/2020; 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization