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

Model Number	G57453
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter: a patient of unspecified gender and age underwent an unspecified procedure previously in which the zilver vena venous self-expanding stent, g57453, was used.On (b)(6) 2023 it was noted that the stent had migrated into the patient's heart.The patient is doing okay.Updated information: noted during other procedure, ultrasound done at 1 month and 6 months and these images can be shared.

• 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: 16910634
• Report Number: 3005580113-2023-00057
• Device Sequence Number: 12564190
• Product Code: QAN
• UDI-Device Identifier: 10827002574530
• UDI-Public: (01)10827002574530(17)240428(10)C1824523
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2023
• Report Date (Section F): 05/10/2023

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: 04/28/2024
• Device Model Number: G57453
• Device Catalogue Number: ZVT7-35-120-16-60
• Device Lot Number: C1824523
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/24/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2023
• Date Device Manufactured: 04/28/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 34 KG