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

Model Number G57449

Device Problem Migration (4003)

Patient Problem Foreign Body Embolism (4439)

Event Date 01/28/2022

Event Type  Injury  

Event 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.".

Manufacturer Narrative

Common name - qan.

Manufacturer Narrative

Common device name: common name - qan.

Event 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
• MDR Text Key: 286326308
• Report Number: 3005580113-2022-00032
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574493
• UDI-Public: (01)10827002574493(17)240514(10)C1829820
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Report Sent to FDA: 03/01/2022
• Distributor Facility Aware Date: 01/31/2022
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2022
• Date Device Manufactured: 05/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male