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

Catalog Number BXA055902E

Device Problem Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The device remains implanted, therefore an engineering evaluation could not be performed.Dicom imaging series have been requested for evaluation.Evaluation of the images is ongoing.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

On (b)(6) 2019, the patient underwent a branched endovascular aortic repair (bevar) to treat a thoracoabdominal aneurysm type ii with a customized zenith zenith tx2® taa endovascular graft with pro-form® (cook medical) and a custom-made 5-branched endoprosthesis (cook medical).Three gore® viabahn® vbx balloon expandable endoprostheses (viabahn vbx device) were implanted to extend the branches into the left renal artery, the right renal artery and the celiac trunc.One viabahn vbx device was placed in each of these arteries.The mesenteric artery was treated with a begraft peripheral plus stent graft (bentley) which was extended with a gore® viabahn® endoprosthesis with propaten bioactive surface.Reportedly the patient had a pre-existing high-grade stenosis of the celiac trunc.All viabahn vbx devices were navigated to their intended locations and deployed without issues.Reportedly, after implantation of the viabahn vbx device placed in the celiac trunk, the device appeared to have a ligamentous constriction between two wire rows.They post-dilated the device using a 7 mm balloon catheter inflated to 16 atm, but the constriction could not be resolved, it was still at 50 %.Reportedly the viabahn vbx device was compressed because of the radial forces due to the pre-existing stenosis.They decided to treat the residual stenosis with an 8 mm x 37 mm begraft peripheral plus stent graft (bentley) which was placed inside the viabahn vbx device.After this the stenosis was reduced to 30 %.At the end of the procedure all viabahn vbx devices were patent.The patient tolerated the procedure.

Manufacturer Narrative

H6-code 4112: dicom imaging series have been provide for evaluation.H6-code 213: the imaging evaluation states the following: ¿ images available for evaluation: intra-operative angiogram with all information anonymized.Date on imaging is 10/5/2020.Per psg coordinator, the actual procedure date was (b)(6) 2019.¿ there appears to be an area of vessel with possible limited flow.¿ images appear to show ballooning of a stent.¿ there appears to be an area of device that appears to be narrowed.¿ with available imaging this narrowing does not appear to be resolved.¿ vessel appears to be patent.

• 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: 10762097
• MDR Text Key: 214406555
• Report Number: 2017233-2020-01390
• 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: study
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2021
• Device Catalogue Number: BXA055902E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 75