MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA; STENT, ILIAC VEIN

Lot Number C1772 420

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 09/10/2021

Event Type  Injury  

Event Description

Stent that was placed in right cfv (common femoral vein) was found to have migrated to the patient's heart when he came into the hospital for another procedure.He underwent venogram for evaluation of the left iliac venous system when his right common iliac vein stent was observed within the right atrium.Cardiothoracic surgery and cardiology were consulted who recommended evaluation with echocardiography.This was obtained and the patient is now being admitted for observation overnight.

• Brand Name: ZILVER VENA
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): COOK IRELAND LTD; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12518631
• MDR Text Key: 272954784
• Report Number: 12518631
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: C1772 420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 18980 DA
• Patient Weight: 113