MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT

Model Number	G57449
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter: "today i was made aware of an incident that occurred as a result of a zilver vena c57449 (16x140) stent that was placed by (surgeon)l at c43414-4 on (b)(6) 2022.The stent was placed via femoral access without incident however upon arrival home the patient experienced shortness of breath.He was sent to the hospital where it was determined that the stent had migrated to the patient¿s lungs.An emergency surgical procedure was performed by a cardiotheracic surgeon to remove the stent.Additional subsequent procedures may also need to be performed however the patient is stable and walking around post surgery.".
Additional Manufacturer Narrative
Common name - qan.
Additional Manufacturer Narrative
Common device name: common name - qan.
Event or Problem Description
According to the initial reporter: "today i was made aware of an incident that occurred as a result of a zilver vena c57449 (16x140) stent that was placed by (surgeon)l at c43414-4 on (b)(6) 2022.The stent was placed via femoral access without incident however upon arrival home the patient experienced shortness of breath.He was sent to the hospital where it was determined that the stent had migrated to the patient¿s lungs.An emergency surgical procedure was performed by a cardiotheracic surgeon to remove the stent.Additional subsequent procedures may also need to be performed however the patient is stable and walking around post surgery.".

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 13633333
• Report Number: 3005580113-2022-00032
• Device Sequence Number: 13996886
• Product Code: QAN
• UDI-Device Identifier: 10827002574493
• UDI-Public: (01)10827002574493(17)240514(10)C1829820
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2022
• Report Date (Section F): 03/01/2022

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: 05/14/2024
• Device Model Number: G57449
• Device Catalogue Number: ZVT7-35-80-16-140
• Device Lot Number: C1829820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/31/2022
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2022
• Date Device Manufactured: 05/14/2021
• 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; Life Threatening
• Patient Sex: Male
• Date Report Sent to FDA: 03/01/2022