MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; STENT, ILIAC VEIN

Catalog Number	ZVT7-35-80-16-100
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Fever (1858)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The practice was notified of a stent migration involving a cook zilver vena stent (ref zvt7-35-80-16-100, g57448, lot c1769829) which was placed by dr (b)(6) on (b)(6) 2021.Surveillance ultrasounds in our office last identified the stent visualized in the common iliac artery (target vessel) on (b)(6) 2022.The patient failed to follow up with our practice after that date.The stent was incidentally found in the heart on or around (b)(6) 2024 during a fever workup the patient underwent at hartford healthcare.Removal was attempted endovascularly but ultimately achieved through open thoracotomy due to adherence to the tricuspid valve, and necessitating a tricuspid valve replacement.To our best knowledge, the patient is alive at this time.**please provide the originator a list of any additional manufacturer questions required for investigation.(b)(4) 24jul2024.Are images of the device or procedure available? did the patient have pre-existing conditions? if yes, please specify: please describe the native state of the vessel (ie was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other if other, please specify: was a stent previously placed during previous procedures? was the device used percutaneously? where on the patient was the percutaneous access site? was the access site jugular or femoral? n/a, jugular, femoral other if other, please specify: what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? if other, please specify the following information has been requested & received via email on 15aug2024.(b)(4) 15aug2024 the investigation team has asked if you can confirm where the device was initially placed? it was deployed in the right common iliac vein.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Common Device Name: STENT, ILIAC VEIN
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 20034341
• Report Number: 3005580113-2024-00051
• Device Sequence Number: 19582735
• Product Code: QAN
• UDI-Device Identifier: 10827002574486
• UDI-Public: (01)10827002574486(17)231020(10)C1769829
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2024
• Report Date (Section F): 08/21/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2023
• Device Catalogue Number: ZVT7-35-80-16-100
• Device Lot Number: C1769829
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/24/2024
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Date Device Manufactured: 10/20/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/21/2024