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

Catalog Number BXA075902E

Device Problem Obstruction of Flow (2423)

Patient Problems Occlusion (1984); Thrombosis (2100); Thrombus (2101)

Event Date 05/03/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 four gore® viabahn® vbx balloon expandable endoprostheses were implanted during an endovascular aortic repair (evar).Percutaneous axillary access was gained by a down-cut.During the procedure heparin was used as antiplatelet/anticoagulant.The viabahn® vbx devices were used as bridging devices to the right renal artery, the left renal artery, the coeliac trunk and the superior mesenteric artery (4-branched evar).The study database indicates that all viabahn® vbx devices were successfully placed and deployed as intended without abnormalities noticed.All viabahn® vbx devices were patent at the end of the procedure.On (b)(6) 2019, 30 days after implantation, the patient presented with an occlusion of the right renal artery and the viabahn® vbx device, which was placed in the right renal artery, because of thrombosis.The study database indicates that the adverse event was related to this viabahn® vbx device.Hospitalization was required for this event, but no treatment was initiated.It was stated that the patient has complaints since two weeks and the study database indicates that the event is not yet resolved.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: sibylle staerk ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8641142
• MDR Text Key: 146088758
• Report Number: 2017233-2019-00373
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: BXA075902E
• Device Lot Number: 18541819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2018
• 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): Hospitalization
• Patient Age: 77 YR
• Patient Weight: 89