BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 3932517 · Received July 14, 2014

    Report

    Report Number
    2025587-2014-00470
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    December 4, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE REPORTED INFORMATION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. THE DEVICE WAS NOT RETURNED, AND A ROOT CAUSE OF THE DISLODGEMENT COULD NOT BE DETERMINED FROM THE LIMITED INFORMATION AVAILABLE; HOWEVER, POTENTIAL FACTORS INCLUDE INADEQUATE DEPLOYMENT (DUE TO IMPROPER SIZING BETWEEN VALVE AND ANNULUS, IRREGULAR PATIENT ANATOMY, OR INCOMPLETE FRAME EXPANSION) AND INCOMPLETE DETACHMENT OF THE VALVE FROM THE DELIVERY CATHETER SYSTEM.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE POPPED OUT OF ITS TARGETED POSITION WHEN IT WAS ONE-THIRD DEPLOYED, STILL LOADED ONTO THIS DELIVERY CATHETER SYSTEM (DCS). AS THE PHYSICIAN WAS RETRIEVING THE DCS AND VALVE, THE INTRODUCER SHEATH BEING USED KINKED, AND THE VALVE BECAME STUCK IN THE CURVATURE OF THE ASCENDING AORTIC ARCH. DUE TO THE SUBCLAVIAN APPROACH BEING USED AND RISK OF DISSECTING THE SUBCLAVIAN ARTERY, OPEN HEART SURGERY WAS PERFORMED TO RETRIEVE THE DCS AND VALVE, AND IMPLANT ANOTHER MODEL VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE VALVE AND DCS WERE DISCARDED BY THE CUSTOMER. THE INTRODUCER SHEATH WAS A NON-MEDTRONIC DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410925 ACCUTRAK DELIVERY CATHETER SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION DCS-C4-18FR 0007134523

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention MCS-P3-29-AOA, B245216