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

Model Number G57453

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 04/24/2023

Event Type  Injury  

Event Description

According to the initial reporter: a patient of unspecified gender and age underwent an unspecified procedure previously in which the zilver vena venous self-expanding stent, g57453, was used.On (b)(6) 2023 it was noted that the stent had migrated into the patient's heart.The patient is doing okay.Updated information: noted during other procedure, ultrasound done at 1 month and 6 months and these images can be shared.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 16910634
• MDR Text Key: 314987826
• Report Number: 3005580113-2023-00057
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574530
• UDI-Public: (01)10827002574530(17)240428(10)C1824523
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2023,05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: G57453
• Device Catalogue Number: ZVT7-35-120-16-60
• Device Lot Number: C1824523
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/24/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2023
• Date Device Manufactured: 04/28/2021
• 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
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 34 KG