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

Catalog Number VBCR081002A

Device Problem Activation Failure (3270)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b01: engineering evaluation results: the viabahn® device was returned to gore for evaluation, and the endoprosthesis was observed to be partially expanded.The evaluation has observed the deployment mechanism to be functional: the deployment line was not caught on any part of the device and deployment continued during evaluation.Procedural deployment of the device can be impacted by different factors including but not limited to zipper integrity, delivery system support or stiffness, or presence of dried fluid on the device or within the catheter dual lumen.The investigation could not confirm the cause of the reported hazardous situation nor the primary device failure mode potentially associated with this event.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

The following was reported to gore: during an endovascular revision of the dialysis access (unknown graft manufacturer) in the patient's left upper arm, the deployment line of a gore® viabahn® endoprosthesis (viabahn device) became stuck and could not be further deployed.As reported, the deployment line did not break, there were no pre-existing stents, and the stenotic occlusion was pre-ballooned.The partially expanded device was removed from patient with no issues.The physician was able to use a new viabahn device to complete the treatment.The patient did not experience any adverse consequences.

Manufacturer Narrative

B7: patient medication history and list of medications were added.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18274689
• MDR Text Key: 330462821
• Report Number: 2017233-2023-04451
• Device Sequence Number: 1
• Product Code: PFV
• 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: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: VBCR081002A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 109 KG