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

Model Number G57448

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

Product code: qan.

Event Description

Stent migration from right common fem to the atrium.Patient is stable and not symptomatic.Information from medwatch report received (b)(6) 2021: 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 VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 12597930
• MDR Text Key: 281282562
• Report Number: 3005580113-2021-00116
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574486
• UDI-Public: (01)10827002574486(17)231030(10)C1772420
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 10/06/2021,10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2023
• Device Model Number: G57448
• Device Catalogue Number: ZVT7-35-80-16-100
• Device Lot Number: C1772420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR
• Patient Weight: 114