MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZVT7-35-120-16-140

Device Problem Migration (4003)

Patient Problem Arrhythmia (1721)

Event Date 03/22/2023

Event Type  Injury  

Event Description

According to the initial reporter, the stent was implanted on (b)(6) 2023 with no complications.Everything looked good in multiple imaging.The patient woke up with heart palpitations on (b)(6) 2023.The implanting physician told the patient to go to the er.They did an x-ray and found that the stent had migrated to the atrium.The implanting physician is trying to retrieve the stent with the help of an interventional radiologist at the time the rep is reporting the complaint.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 16590080
• MDR Text Key: 311751892
• Report Number: 3005580113-2023-00036
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2023,03/22/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: ZVT7-35-120-16-140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2023
• 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: Female