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

Catalog Number BXA052902E

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/06/2021

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, no further investigation can be performed.No images are available for evaluation.The physician had expressed concern that the patient's unauthorized discontinuation of anti-platelet therapy may have contributed to the stenosis inside the gore® viabahn® vbx balloon expandable endoprosthesis.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

It was reported to gore that the patient underwent endovascular treatment with a gore® viabahn® vbx balloon expandable endoprosthesis because of a pseudoaneurysm of the renal artery on (b)(6) 2021.Reportedly, there were no complications in the procedure and the patient was initially well after the operation.It was stated, that sometime in mid-july the patient decided to stop taking his anti-platelet medicine of his own accord.The physician then ordered imaging to check the patency of the stent.The images demonstrated that the patient suffered a mild stenosis in the endoprosthesis in his renal artery.It was reported that the surgeon believes that the stenosis is closely associated with the discontinuation of the anti-platelet medication.On (b)(6) 2021, the stenosis was treated with a second gore® viabahn® vbx balloon expandable endoprosthesis during an endovascular reintervention.After this renal function was restored.

Manufacturer Narrative

Phr: a review of the manufacturing records indicated the lot met all pre-release specifications.A review of the sterilization records indicated the lot met all pre-release sterilization specifications.A review of the heparin coating records indicated the lot met all pre-release sterilization specifications.

• 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: 12467574
• MDR Text Key: 271292145
• Report Number: 2017233-2021-02371
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2023
• Device Catalogue Number: BXA052902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2020
• 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: 49 YR
• Patient Sex: Male