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

Model Number	VBCR080501A
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of device manufacturing record history is current in progress.Device was returned and evaluation is currently in progress.Patient information (id, gender, weight, dob and relevant medical history) was requested but no response has been received from user facility.Additional information related to potential adverse event was requested.As of today, no information has been provided.In a conservative approach, this report is being submitted.
Event or Problem Description
The following was reported to gore by user facility representative: during vascular access treatment, a gore® viabahn® endoprosthesis did not initially deploy, then started deploying (expanding) when trying to remove and it was captured with a sheath.No patient harm was reported.Further information was requested but not made available as of today.
Additional Manufacturer Narrative
Engineering evaluation confirms the reported partial deployment.The distal shaft of device was kinked approximately 2cm from the transition area.Approximately 1.2cm of the endoprosthesis was expanded at the distal end.The endoprosthesis was compressed longitudinally about 2cm distally.During engineering evaluation, the deployment knob was pulled and deployment was able to continued.The investigation could not confirm the cause of the reported partial deployment or the primary device failure mode.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13595278
• Report Number: 2017233-2022-02762
• Device Sequence Number: 11251949
• Product Code: PFV
• UDI-Device Identifier: 00733132623501
• UDI-Public: 00733132623501
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

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: 03/10/2024
• Device Model Number: VBCR080501A
• Device Catalogue Number: VBCR080501A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown