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

Catalog Number BXAL085902E

Device Problem Material Deformation (2976)

Patient Problem Aneurysm (1708)

Event Date 02/27/2021

Event Type  malfunction  

Manufacturer Narrative

The device is on the way to the manufacturer to perform a further investigation.Evaluation code 213: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.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

It was reported to gore that patient underwent endovascular treatment for a four times branched endovascular aneurysm repair (evar) with a gore viabahn vbx balloon expandable endoprosthesis (vbx-device) as bridging stent for a fenestrated aortic prosthesis.Main body was the inner branch customized prosthesis of jotec.It was stated that access was made femoral on the right side with an oscor 8f introducer sheath over a rosen guidewire.It was reported that during advancement of the vbx-device through the 180 turn of the sheath the stent slipped off the catheter.As there was still enough adhesion between stent and catheter, the prosthesis could be removed without any further activities.It was stated that another vbx-device was implanted successfully.There was no report of patient harm.

Manufacturer Narrative

Investigation conclusion: the returned gore® viabahn® vbx balloon expandable endoprosthesis was unremarkable, aside from the endoprosthesis being separated from the delivery catheter.A review of the manufacturing records indicated the device lot met all pre-release manufacturing specifications, including a final visual inspection and confirmation of acceptable stent profile using an image measurement system.The failure mode of stent displacement or dislodgement during insertion is captured within the gore® viabahn® vbx balloon expandable endoprosthesis risk files.The root cause of the stent dislodgement during advancement could not be established.

• 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: 11515492
• MDR Text Key: 243922364
• Report Number: 2017233-2021-01774
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132636952
• UDI-Public: (01)00733132636952(17)230716
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2023
• Device Catalogue Number: BXAL085902E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ¿INNER BRANCH¿ CUSTOMIZED PROSTHESIS OF JOTEC.
• Patient Age: 74 YR