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 Problems Occlusion (1984); Thrombus (2101)

Event Date 10/30/2020

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 was reported to gore: on (b)(6) 2020, the patient presented with a venous anastomosis stenosis of an arteriovenous graft in the auxiliary vein in the upper left arm and underwent treatment utilizing a gore® viabahn® endoprosthesis with heparin bioactive surface (vsx).The patient tolerated the procedure.On (b)(6) 2020, the patient underwent dialysis treatment observed no shunt sounds.The physician then performed an ultrasound and identified an occlusion of the vsx device and vascular thrombus.The patient then underwent treatment for the occluded endoprosthesis and thrombus and a thrombectomy and percutaneous transluminal angioplasty were performed, the physician confirmed resolution of the occlusion.The patient tolerated the procedure.

Event Description

The following was reported to gore: on (b)(6), 2020, the patient presented with a venous anastomosis stenosis of an arteriovenous graft in the auxiliary vein in the upper left arm and underwent treatment utilizing a gore® viabahn® endoprosthesis with heparin bioactive surface (vsx).The patient tolerated the procedure.On (b)(6), 2020, the patient underwent dialysis treatment observed no shunt sounds.The physician then performed an ultrasound and identified an occlusion of the vsx device and vascular thrombus.The patient then underwent treatment for the occluded endoprosthesis and thrombus and a thrombectomy and percutaneous transluminal angioplasty were performed, the physician confirmed resolution of the occlusion.The patient tolerated the procedure.

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.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: 11171464
• MDR Text Key: 226841190
• Report Number: 2017233-2021-01604
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: JHJR061002J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR