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

Catalog Number	VBCR081002A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: patient information was requested, but no information was provided therefore an internally generated number was used.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
On (b)(6) 2024, a patient underwent treatment for an unknown reason where an 8 mm x 10 cm gore® viabahn® endoprosthesis was intended to be used in an unknown location.It was reported the physician advanced the delivery catheter using an 8f introducer sheath (brand unknown) over an.035" advantage glidewire to the target treatment zone.Reportedly, during deployment the line was pulled and became caught, causing the deployment line to become stretched out near the turn around.Reportedly, deployment was aborted, and the physician withdrew the catheter, with the endoprosthesis fully constrained.There was no distal expansion initiated of the endoprosthesis and the deployment line did not break.It was reported there was no impact to the patient.
Additional Manufacturer Narrative
A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Product return evaluation: this complaint was initiated on the basis of information received from the field.The information reported in the complaint indicates the user experienced an inability to deploy the device (stuck deployment line after partial deployment), there was no expansion of the endoprosthesis, and the device was subsequently withdrawn without additional complication.The viabahn® device was returned to gore for evaluation, and deployment of the inner zipper had not been initiated.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.The cause for the reported deployment difficulty could not be established.The investigation could not confirm the cause of the reported hazardous situation nor the primary device failure mode potentially associated with this event.Updated: h6: evaluation codes - include investigation findings.Updated: b4: describe event or problem - further information received from the field.
Event or Problem Description
On (b)(6) 2024, a patient underwent treatment for stenosis where an 8 mm x 10 cm gore® viabahn® endoprosthesis (gore® viabahn® device) was intended to be used in the cephalic arch.It was reported the lesion was pre-dilated and then the physician advanced the delivery catheter using an 8f introducer sheath (brand unknown) over an.035" advantage glidewire to the target treatment zone.Reportedly, during deployment the line was pulled and became stuck, causing the deployment line to become stretched out near the turn around.Reportedly, deployment was aborted, and the physician withdrew the catheter, with the endoprosthesis fully constrained.It was reported there was no impact to 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20191361
• Report Number: 2017233-2024-05298
• Device Sequence Number: 7113251
• Product Code: PFV
• UDI-Device Identifier: 00733132623532
• UDI-Public: 00733132623532
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/30/2024

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 Expiration Date: 08/02/2025
• Device Catalogue Number: VBCR081002A
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown