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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/07/2019

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, an investigation on the device cannot be performed.The author was contacted and further details requested, such as lot- / serial no., implant date, patient data and possible root cause.Date of event was determined as date when literature article was published, here september 7, 2019.As patient age the mean age 72 years was determined and as gender male as mentioned in the article.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

The following publication was reviewed: initial clinical experience with the gore¿ viabahn¿ vbx balloon expandable stent-graft in branched and fenestrated endovascular aortic repair published by e.Beropoulis in the cardiovascular and interventional radiology.2019;42(3 supplement): page 328.The purpose of this study was to evaluate the initial clinical performance of the new gore¿ viabahn¿ vbx balloon expandable endoprosthesis in f/bevar.Between december 2017 and october 2018, fifty patients (41 male, mean age 72 years) fulfilled the inclusion criteria.The primary endpoint was reached in all of the 166 vbx implanted.122 branches (renal arteries: 74, superior mesenteric artery: 25 and celiac trunk: 21) sealed exclusively with vbx.It was stated that there was a single stent-related reintervention due to stent occlusion of a left renal artery postoperatively, which was treated successfully with aspiration thrombectomy and relining with a bare metal stent.

Manufacturer Narrative

Requests were emailed to the author to provide additional information like patient information, serial numbers, dates of procedure, onset date of occlusion, date of reintervention, imaging series, etc.The requests remained unanswered.The serial number remains unknown, therefore a review of the manufacturing records could not be performed.The device remains implanted in the patient, therefore a device evaluation could not be performed.With no additional information provided, gore is unable to perform further investigations of this complaint.H6 evaluation codes investigation findings 3221 was selected because no device investigation was able to be performed as no further information was able to be obtained from the authors (despite multiple attempts) and gore did not receive the device back for evaluation (still implanted in patient).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: occlusion.Device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: thrombosis or occlusion.

• 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: 12226083
• MDR Text Key: 263465789
• Report Number: 2017233-2021-02195
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 72 YR
• Patient Sex: Male