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

Model Number	G57455
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pancreatitis (4481)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter, a 16x140 zilver vena stent was placed in the iliac vein in (b)(6) 2022.The patient returned for a duplex ultrasound in (b)(6) 2023 and the stent was seen in the iliac vein.On (b)(6) 2023, the patient went to the emergency room for pancreatitis.The patient was given a ct scan for his pancreatitis.It was incidentally discovered that the zilver stent was no longer in the iliac vein and had migrated to the right ventricle.

• 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: 16854320
• Report Number: 3005580113-2023-00050
• Device Sequence Number: 6771188
• Product Code: QAN
• UDI-Device Identifier: 10827002574554
• UDI-Public: (01)10827002574554(17)240702(10)C1846478
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2023
• Report Date (Section F): 05/02/2023

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: 07/02/2024
• Device Model Number: G57455
• Device Catalogue Number: ZVT7-35-120-16-140
• Device Lot Number: C1846478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/12/2023
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2023
• Date Device Manufactured: 07/02/2021
• 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 Sex: Unknown
• Date Report Sent to FDA: 05/02/2023