MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

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

Patient Problem Renal Impairment (4499)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, a further investigation on the device cannot be performed.The author was contacted to ask for further details like event date, serial no., implant date as well as possible root cause.Date of event was determined as date when literature article was published, here (b)(6) 2020.As patient age (b)(6) was determined and as gender female 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 literature was reviewed: ¿acute kidney injury following percutaneous mechanical thrombectomy of subclavian artery stent graft thrombosis: a case report¿ published by tajana turk et al.In the cardiovascular and interventional radiological society of europe endovascular 2020, 3:27.The article presents a case of (b)(6) caucasian female with subclavian artery aneurysm causing distal embolization and hand ischemia.The aneurysm was treated with a gore® viabahn® endoprosthesis with propaten bioactive surface, but the patient returned 3 months later with a sudden onset of left arm pain and pallor.Ultrasound showed complete graft thrombosis.After graft recanalisation, angiojet pmt was performed which resulted in dialysis-requiring acute kidney injury.

Manufacturer Narrative

Multiple attempts were made to obtain additional information from the author about this event, like event date, serial no., implant date as well as possible root cause.No additional information was provided; therefore, no further investigation could be conducted.A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.As no further information was received from the author, this investigation is considered complete, the cause of the complaint was unable to be determined.According to the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface 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: vessel thrombosis, 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® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 12346799
• MDR Text Key: 267444030
• Report Number: 2017233-2021-02291
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: HR
• PMA/PMN Number: P040037
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• 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: 03/29/2022
• 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: 66 YR
• Patient Sex: Female