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

Catalog Number BXA087902E

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

Patient Problem Aneurysm (1708)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, an investigation on the device cannot be performed.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) 2020, the patient underwent endovascular treatment for an thoracoabdominal aneurysm ii with 4 gore® viabahn® vbx balloon expandable endoprostheses (vbx-devices).A 4 times branched endovascular aortic repair (bevar) was performed with a medtronic protegé everflex endovascular graft as main aortic body.Four vbx-devices were implanted to treat the aneurysm, one in the superior mesenteric artery (sma), one in the right renal artery (rra), one in the left renal artery (rra) and the other in the celiac artery.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) 2021 there were two adverse events.A 1c-endoleak at the sma-branch and an edge-stenosis at the sma-branch was detected.An endovascular reintervention was performed on (b)(6) 2021 at the sma and the issue solved.

Manufacturer Narrative

The device remains implanted in the patient, therefore a device evaluation could not be performed.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.In the instruction for use for the gore® viabahn® vbx balloon expandable endoprosthesis the following is 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, occlusion device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: stenosis, migration.

• 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: 12295294
• MDR Text Key: 265635570
• Report Number: 2017233-2021-02226
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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
• Report Date: 05/13/2022

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: 11/14/2022
• Device Catalogue Number: BXA087902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• 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
• Treatment: BXAL087902E SN (B)(6) BXAL067902E SN (B)(6).; BXAL087902E SN (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 67 KG