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	VBJR081002A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a patient underwent treatment in an arteriovenous (av) access fistula or graft (unknown which) in the upper arm using an 8 mm x 10 cm gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn® device).It was reported the physician advanced the delivery catheter through an unknown size / brand sheath over an 0.018" guidewire (brand unknown) to the target treatment site.It is unknown if the treatment area was predilated.Reportedly, the physician pulled the deployment string, but the endoprosthesis did not deploy.The procedure was competed using another 8 mm x 10 cm viabahn® device.It was reported there was no impact to the patient.
Additional Manufacturer Narrative
A1 - patient identifier (in confidence) - information was requested but not provided.This is a internal system generated number.Cbas® heparin surface incorporates carmeda 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.
Additional Manufacturer Narrative
Updated: type of investigation, investigation findings, investigation conclusions a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Product return evaluation: the gore® viabahn® endoprosthesis with heparin bioactive surface was returned to gore for evaluation, and deployment of the inner zipper had not been initiated.The returned device was observed to be consistent with the product listed within the complaint.The entire device was returned with the endoprosthesis constrained and mounted on the delivery catheter.Evaluation of the returned device indicates a partially deployed outer zipper to the turnaround, with notable tension on the deployment line between the transition and turnaround.During evaluation, a guidewire could be passed tip to hub through the transition and deployment was continued successfully with traction at the knob.The evaluation has observed the deployment mechanism to be functional: deployment successfully continued at the knob during evaluation.The cause for the reported deployment difficulty could not be established.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: 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: 19122127
• Report Number: 2017233-2024-04836
• Device Sequence Number: 8230295
• Product Code: PFV
• UDI-Device Identifier: 00733132623822
• UDI-Public: 00733132623822
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P130006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VBJR081002A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown