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 Device Stenosis (4066)

Patient Problem Implant Pain (4561)

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.A review of the manufacturing records for the device could not be conducted because the serial / lot number remains unknown.Without a lot number or device serial number, the manufacturing date and / or production details cannot be determined, and the information provided to gore cannot be connected to a specific device.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.The gore® viabahn® endoprosthesis with heparin bioactive surface instruction for use (ifu), section hazards and adverse events states, complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: thrombosis or occlusion.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.

Event Description

On (b)(6) 2024, this patient underwent an endovascular treatment for venous (basilic) anastomotic stenosis of an arteriovenous (av) graft using a gore® viabahn® endoprosthesis with heparin bioactive surface (gore® viabahn® device).On (b)(6) 2024 the patient presented with pain and swelling at the location where the gore® viabahn® device had been implanted.It is unknown for how long the patient was experiencing these symptoms.The physician performed an exam (type unknown) and confirmed the endoprosthesis had occluded.An emergent operation was performed, during which the endoprosthesis was explanted and replaced by a polyurethane vascular graft.The patient tolerated the procedure, and the pain was resolved.According to the physician, no allergies were declared by the patient preoperatively.The patient had no fever, nor infection.When the gore® viabahn® device was explanted, no thrombus was observed.The explanted endoprosthesis was retained by the hospital for pathological examination.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19006654
• MDR Text Key: 338945284
• Report Number: 2017233-2024-04773
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: JHJR061002J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention