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

Catalog Number BXAL085902E

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Vascular Problem (4441); Insufficient Information (4580)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted at the moment, and the next angiography was not yet performed and the probable re-intervention was not made, a further investigation cannot be conducted now.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

A study alert was received from imedidata database.The patient referenced in this event file is enrolled in a registry which has been designed with broad eligibility criteria to capture real-world gore® viabahn® vbx balloon expandable endoprosthesis use, in multiple pathologies and in conditions needing preservation of peripheral vessels.The following was reported to gore: on (b)(6) 2019, the patient underwent endovascular treatment for an endoleak iii with two gore® viabahn® vbx balloon expandable endoprostheses (vbx-devices).Two vbx-devices were implanted to treat the endoleak iii, one in the superior mesenteric artery (sma) and the other in the right renal artery (rra).The vbx-devices were navigated to its intended location and deployed without issues.At the end of the procedure the vbx devices were patent.The patient tolerated the procedure.On (b)(6) 2019 there was an adverse event, again an endoleak iii.The adverse event is not recovered yet.A re-intervention must be done.

Manufacturer Narrative

The device remains implanted in the patient.Therefore a device evaluation could not be performed.Images were received from the hospital and an imaging evaluation performed: summary: ¿ one time point is available for evaluation: post-implantation cta dated (b)(6) 2021.¿ there appears to be pooling contrast outside the implanted devices.¿ comparison axial images appear to show the pooling contrast in the anterior aneurysm sac extends toward the left side of the sac.¿ the pooling contrast appears to extend toward the posterior aneurysm sac.¿ there appears to be lumbar arteries communicating with contrast in the sac.¿ cannot confirm ante grade or retrograde flow in the lumbars with available imaging.Cannot confirm endoleak type with available imaging.With the information provided to gore, the cause of the reported event was unable to be determined.As two devices were implanted, the other device was reported with manufacturer reporter number 2017233-2021-02172.In the instruction for use for the gore® viabahn® vbx balloon expandable endoprosthesis the following was stated: hazards and adverse events: procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: malposition.Device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: device failure.

Manufacturer Narrative

B5 "describe event or problem" was updated referring to further details received.Further images were requested and received from the hospital and an imaging evaluation performed.Evaluation of the provided clinical images confirms the reported endoleak at the time of imaging on (b)(6) 2021, but an endoleak involving one of two gore® viabahn® vbx balloon expandable endoprostheses (vbx devices) implanted (b)(6) 2019, which was reportedly observed (b)(6) 2019, and its cause or relationship relative to the other non-gore devices could not be established with the available information.The information reported in the complaint does not reasonably suggest a potential malfunction has occurred.The provided images are dated (b)(6) 2021 which is after the procedure on (b)(6) 2021, during which the originally implanted vbx devices were relined and a resulting type ii endoleak was reportedly observed.

Event Description

The following was reported to gore: in 2015 the patient underwent a thoracic endovascular aortic repair procedure (tevar) with a gore- and a medtronic device.In 2018 a branched endovascular aneurysm repair was performed with a cook-device.The superior mesenteric artery (sma) and both renal arteries were connected with atrium v12 stents.The celiac trunk was connected with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device) and the left renal artery extended with a vbx-device because of a type ic endoleak observed at the end of the v12 stent (which wasn¿t connected deep enough).On (b)(6) 2019, the patient underwent endovascular treatment for a type iii endoleak with two vbx-devices, one in the sma and the other in the right renal artery (rra).The vbx-devices were navigated to their intended locations and deployed without issues.At the end of the procedure the vbx-devices were patent.The patient tolerated the procedure.On (b)(6) 2019, there was a suspected type ii or type iii endoleak between the cook main body and a vbx-device.It was not clear which of the vbx-devices was associated with the endoleak.A re-intervention was performed on (b)(6), 2021.This involved a relining of the celiac trunk branch and pta was also performed to solve the possible type iii endoleak.After treatment was performed, there was still an endoleak visible, now believed to be type ii with unknown origin.It was reported the patient will continue to be monitored.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12171733
• MDR Text Key: 261688701
• Report Number: 2017233-2021-02173
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2022

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: 03/28/2022
• Device Catalogue Number: BXAL085902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 03/25/2022; 11/29/2022
• Supplement Dates FDA Received: 04/22/2022; 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male