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

Model Number VBJR080502A

Device Problem Activation Problem (4042)

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

Event Date 09/06/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, a patient presented for a-v fistula treatment in the left upper arm.A fistulogram and thrombectomy were performed.As reported, the treatment area within the pre-existing bare metal stent (bms) was dilated prior to inserting the 8mm x 5cm gore® viabahn® endoprosthesis with heparin bioactive surface (vsx device).The vsx device was advanced over a victory 0.18 wire through a 7fr short sheath.During deployment, the vsx device expanded about half way when the deployment line broke.The physician was able to pull out everything (device, catheter and all of deployment line) from the patient.A new 8mm x 5cm vsx device was successfully deployed to complete the procedure.The patient did not experience any adverse consequences.

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.Instructions for use for gore® viabahn® endoprosthesis with heparin bioactive surface warnings section state: w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications where the device is deployed within stents or stent grafts other than the gore® viabahn® endoprosthesis.Other devices may interfere with the deployment of the gore® viabahn® endoprosthesis resulting in deployment failure or other device malfunction.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.

Manufacturer Narrative

H6: c19: the engineering evaluation summary states the endoprosthesis was returned fully deployed, so the partial device expansion could not be confirmed.The returned deployment line is consistent with the expected length for this device configuration, and the end of the deployment line is consistent with the trim performed during manufacturing.The dual lumen catheter was returned with the distal shaft inside an introducer sheath.The dual lumen was removed from the introducer sheath for evaluation.The dual lumen catheter was unremarkable.The distal tip was not returned, but evidence of a bond was seen on the end of the distal shaft.The deployment line and knob were returned.The length of deployment line is consistent with the expected deployment line length for this device configuration, and the end of the deployment line is consistent with the trim performed during manufacturing.Therefore, the complaint of a deployment line break could not be confirmed.The root cause of the reported failure modes could not be established.A4 - patient weight was requested, but not made available.B4 - event description was updated.

Event Description

On (b)(6) 2022, a patient presented for a-v fistula treatment in the left upper arm.A fistulogram and thrombectomy were performed.As reported, the treatment area within the pre-existing bare metal stent (bms) was dilated prior to inserting the 8mm x 5cm gore® viabahn® endoprosthesis with heparin bioactive surface (vsx device).The vsx device was advanced over a victory 0.18 wire through a 7fr short sheath.During deployment, the vsx device expanded about half way, resistance was felt when the deployment line broke.The physician was able to pull out everything (device, catheter plus tip, and all of deployment line), along with the sheath, from the patient.After the affected device was removed, the sheath was re-inserted and a new 8mm x 5cm vsx device was deployed to complete the procedure.The patient did not experience any adverse consequences.The physician stated the deployment line likely became stuck on a stent strut.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15571761
• MDR Text Key: 302809779
• Report Number: 2017233-2022-03390
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623815
• UDI-Public: 00733132623815
• Combination Product (y/n): Y
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VBJR080502A
• Device Catalogue Number: VBJR080502A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• 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: 68 YR
• Patient Sex: Male