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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Additional 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

On (b)(6) , 2021, this patient underwent endovascular procedure to treat a venous anastomosis stenosis of an arteriovenous graft located in the basilic vein in the right upper arm using a gore® viabahn® endoprosthesis with heparin bioactive surface.The patient tolerated the procedure.On (b)(6) , 2021, it was observed that the endoprosthesis was occluded with thrombus.On (b)(6) , 2021, a re-intervention was performed to treat the occluded endoprosthesis.Balloon dilatation and thrombolysis were reportedly performed.The event was resolved, and the patient tolerated the procedure.

Manufacturer Narrative

A review of the manufacturing records, including manufacturing, heparin coatings, and sterilization, indicated the device met pre-release specifications.Section h6: investigation findings: was updated to code 213 to reflect this information.G3 corrected to "yes" for combination product.

Manufacturer Narrative

G4: pma/510k number field corrected from p040037 to p130006.

• 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
• MDR Report Key: 11572694
• MDR Text Key: 249113992
• Report Number: 2017233-2021-01814
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2023
• Device Catalogue Number: JHJR061002J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 60