MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Catalog Number JHJR061002J

Device Problem Complete Blockage (1094)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/05/2020

Event Type  Injury  

Manufacturer Narrative

Review of device manufacturing record history confirmed device met pre-release specifications.Device remains implanted; therefore, direct product analysis was not possible.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 was reported from a study: on (b)(6) 2020, patient presented with a venous stenosis of an arteriovenous graft (unknown manufacturer) located in the basilic vein in the patient¿s right upper arm.During the endovascular treatment, a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) was implanted.The patient tolerated the procedure.On (b)(6) 2020, the viabahn device and the arteriovenous graft were found to be occluded with thrombus.On the same day, a cuff dialysis catheter was implanted in the right internal jugular vein to keep the vascular access circuit.

Manufacturer Narrative

H6.Code 213: sterilization task was completed.A review of the sterilization records indicated the lot met all pre-release specifications.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11764756
• MDR Text Key: 250000795
• Report Number: 2017233-2021-01944
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

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: 04/09/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 78 KG