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

Catalog Number VBCR131002A

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

Type of investigation - b14: analysis of production records: a review of the manufacturing records indicated the device met pre-release specifications.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, a patient underwent treatment for central vein stenosis using a 13 mm x 10 cm gore® viabahn® endoprosthesis devices (viabahn® devices) in the innominate vein / vena cava.It was reported the physician accessed the patient through a dialysis access graft in the upper arm using a 10f terumo introducer sheath over an 0.035" guidewire (unknown brand) to the target treatment site.Reportedly, during deployment, the physician pulled the deployment line and the endoprosthesis initiated expansion.It expanded approximately 1 centimeter, before the line could not be pulled any more.The delivery catheter and the sheath were withdrawn from the patient.The procedure was completed using a bd device.It was reported there was no impact to the patient.

Manufacturer Narrative

Updated investigation conclusions: d15 - cause not established updated investigation findings: c19 - no device problem found.Added type of investigation: b01 -testing of actual/suspected device the manufacturing records were reviewed and documented in the product history task.The device lot met all pre-release specifications.Product return evaluation the condition of the gore® viabahn® endoprosthesis as returned was consistent with the primary complaint of partial deployment with a stuck deployment line.The gore® viabahn® endoprosthesis was returned with the endoprosthesis partially deployed and still mounted on the delivery system.The zipper was deployed past the turnaround and the endoprosthesis was partially expanded at the distal end.The complaint of deployment failure with a stuck deployment line could not be independently confirmed based on evaluation of the returned device.Deployment of the device was able to continue when pulling the deployment line from the knob during evaluation, demonstrating that the deployment mechanism was not stuck.The root cause of the partial deployment and stuck deployment line as reported could not be established with the information available.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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: 18882130
• MDR Text Key: 337449155
• Report Number: 2017233-2024-04699
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132645923
• UDI-Public: 00733132645923
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VBCR131002A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• 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 Age: 57 YR
• Patient Sex: Male