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

Catalog Number JHJR061002J

Device Problem Complete Blockage (1094)

Patient Problem No Code Available (3191)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

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 information was reported to gore: on (b)(6) 2020, the patient underwent for stenosis of arterio-venous vascular access graft (avg) in right arm using a gore® viabahn® endoprosthesis with heparin bioactive surface.On (b)(6) 2020, a thrombotic occlusion from the avg arterial anastomosis to the vein at the outflow tract was observed.On (b)(6) 2020, the patient underwent reintervention for thrombectomy.Patient information was requested but will not be made available.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN 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: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10774998
• MDR Text Key: 214387750
• Report Number: 2017233-2020-01403
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2020

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: 12/09/2022
• Device Catalogue Number: JHJR061002J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention