MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number	VBCR081001A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of device manufacturing record history confirmed device met pre-release specifications.Device was discarded at user facility.Therefore, direct product analysis could not be performed.Instructions for use for gore® viabahn® endoprosthesis (ifu) state: contraindications: the gore® viabahn® endoprosthesis is contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.Warnings: special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.
Event or Problem Description
The following was reported to gore: patient presented for a-v outflow treatment of two stenotic areas in the axillary vein.An 8fr sheath was used to advance the gore® viabahn® endoprosthesis.The first stenotic section was crossed and dilated with no issues.A viabahn device (8 x 10) was deployed with no issues.The second section was extremely focal stenosis that did not yield to dilation.However, the physician was able to advance the second viabahn device (8 x 5) through the narrowing in the axillary vein.The viabahn device was deployed and it conformed to the vessel wall.After device was deployed, the delivery catheter could not be withdrawn as it was stuck inside the deployed device.The patient was transferred to a hospital.The deployed viabahn device and catheter were surgically removed from the patient.The stenosis was then treated and the patient's vessel was patched.The patient was reported to be recovering well following the procedure.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8769738
• Report Number: 2017233-2019-00506
• Device Sequence Number: 2115314
• Product Code: PFV
• UDI-Device Identifier: 00733132623525
• UDI-Public: 00733132623525
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2022
• Device Catalogue Number: VBCR081001A
• Device Lot Number: 20571495
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 64