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 05/21/2021

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

The following information was reported to gore: on (b)(6) 2021, this patient underwent endovascular procedure to treat a venous anastomosis stenosis of an arteriovenous graft located in the left upper arm using a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device).The lesion length was reported to be about 2.5 cm.Because the vessel of the lesion was too hard, even pre-dilatation at 24 atm did not result in complete dilation.After the balloon dilation at 24 atm was performed, rupture occurred in the proximal site of the lesion where the balloon contacted.Therefore, although the lesion length was about 2.5 cm, a 10 cm viabahn device (jhjr061002j) was implanted inevitably.On (b)(6) 2021: it was observed that the proximal end of the viabahn device was occluded with thrombus.On the same day, plain old balloon angioplasty and thrombus aspiration were reportedly performed.The blood flow was improved and the patient tolerated the procedure.The physician reportedly stated as below: i believe that the cause was not related to the viabahn device, but a combination of poor inflow and low blood pressure that led to the occlusion.The vascular access has been occluded twice in the past.The fsa reported as below: i confirmed with the physician that the occlusion was not caused by the viabahn device.Although it was a hard lesion, the viabahn device was fully expanded and actually the result was very clean.However, the condition of this disease causes early occlusion when various factors are combined, as in this case.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records indicated the lot met pre-release manufacturing 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
• MDR Report Key: 11902198
• MDR Text Key: 265891542
• Report Number: 2017233-2021-02036
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2023
• Device Catalogue Number: JHJR061002J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1