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

Model Number	G57444
Health Effect - Clinical Codes	Chest Pain (1776); Respiratory Insufficiency (4462)
Date of Event	05/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common name - qan.
Event or Problem Description
According to the initial reporter: "stent is already deployed in the patient.The procedure went great on tuesday; doctor texted (cook representative) today that the patient called in; patient was supposed to be coming in for a duplex ultrasound and, while putting on his shoes, patient experienced chest pain and shortness of breath.At that point the doctor told the patient to come into the e.R.In e.R., they observed that the stent had migrated to left pulmonary artery.Doctor believes that the stent probably thrombosed prior to embolization.Patient was fully anticoagulated (believed to be during the procedure).Doctor said that the patient had no underlying clotting disorder and was seen by hematology.No breakage of the device has been observed.It was further reported that the stent was removed.It was further reported: "patient wife said he has an allergy to bee venom, ct was done afterwards; iliac vein was clean.Possible unknown allergy to stent metal? thrombosis came first; maybe an allergic reaction with an odd inflammatory response under stent; was not able to endothelialize to vessel walls.".

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11964742
• Report Number: 3005580113-2021-00068
• Device Sequence Number: 19780609
• Product Code: QAN
• UDI-Device Identifier: 10827002574448
• UDI-Public: (01)10827002574448(17)231005(10)C1764721
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2021
• Report Date (Section F): 06/08/2021

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: 10/05/2023
• Device Model Number: G57444
• Device Catalogue Number: ZVT7-35-80-14-60
• Device Lot Number: C1764721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR