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

Catalog Number	VBCR131002A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Code manufacturing phr - 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 or Problem Description
The following was reported to gore: on (b)(6) 2024, the patient underwent a revision for an arteriovenous (av) fistula in the upper arm using a gore® viabahn® endoprosthesis (viabahn device).It was reported that the physician was able to reach the target treatment area without any resistance.The physician was ready to initiated deployment when they notice some resistance while pulling the deployment line.The viabahn device started to bowstring.The physician did not try to force it open so they took out the viabahn device out through the sheath.There was no device expansion.The procedure was completed using a new viabahn device.It was reported there was no impact to the patient.
Additional Manufacturer Narrative
Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and the device met all pre-release specifications.The vsx device was returned to gore for evaluation.Evaluation of the returned product indicates the reported complaints of vsx device deployment failure and bowstringing could not be independently confirmed.The vsx device as returned for evaluation was partially deployed with partial expansion of the endoprosthesis.It was reported that deployment during the procedure was not able to be initiated, however deployment was attempted on the back table after removal from the patient.Deployment of the returned vsx device was able to continue when pulling the deployment line from the knob, demonstrating that the deployment mechanism itself was not stuck; no bowstringing was observed.The root cause of the vsx device deployment failure and bowstringing of the endoprosthesis as reported could not be established with the information available.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.B4: updated description event.D8/d9: device was sent to gore for device evaluation.H6: removed code b22 and added code b01 under type of investigation.H6: removed code d16 and added code d15 under investigation conclusions.
Event or Problem Description
The following was reported to gore: on (b)(6) 2024, the patient underwent a revision for an arteriovenous (av) fistula in the upper arm using a gore® viabahn® endoprosthesis (viabahn device).It was reported that the physician was able to reach the target treatment area without any resistance using a 10 fr terumo introducer sheath and.035" guidewire (brand unknown).The physician was ready to initiated deployment when they notice some resistance while pulling the deployment line.The viabahn device started to bowstring.The physician did not try to force it open so they took out the viabahn device out through the sheath.There was no device expansion.The procedure was completed using a new viabahn device.It was reported there was no impact to the patient.Deployment of device was attempted on the back table after removal from the patient.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19506044
• Report Number: 2017233-2024-05028
• Device Sequence Number: 12641182
• Product Code: PFV
• UDI-Device Identifier: 00733132645923
• UDI-Public: 00733132645923
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 08/05/2024

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: VBCR131002A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2023
• 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