BEUDAMED
    FDA Adverse Event Death Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 4182249 · Received October 17, 2014

    Report

    Report Number
    2025587-2014-00770
    Event Type
    Death
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    November 11, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. NO CONCLUSION CAN BE MADE TO WHAT CAUSED THE DEVICES TO MIGRATE. AS PERIVALVULAR LEAK WAS NOTED, IT WAS POSSIBLE THAT THE DEVICES WERE NOT SEATED/ANCHORED PROPERLY, WHICH LED TO MIGRATION WHEN THE DELIVERY SYSTEM WAS REMOVED. CHALLENGING PATIENT ANATOMY MAY ALSO HAVE CONTRIBUTED TO THIS CASCADE OF EVENTS. AS THIS DEVICE WAS NOT RETURNED FOR EVALUATION, A FAILURE MECHANISM WAS NOT ABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER PULMONARY VALVE INTO ANOTHER MANUFACTURER¿S VALVE, THE PATIENT PASSED AWAY AFTER THE VALVES AND A STENT MIGRATED INTO THE RIGHT VENTRICLE AND RESULTED IN CARDIAC ARREST. THE PATIENT¿S MEDICAL HISTORY INCLUDED TETRALOGY OF FALLOT STATUS WITH A POST-TRANSANNULAR PATCH PLACED 27 YEARS PRIOR TO THIS PROCEDURE. FOLLOWING PLACEMENT OF A MAIN PULMONARY ARTERY-RIGHT PULMONARY ARTERY STENT, THE TRANSCATHETER-DELIVERED VALVE FROM ANOTHER MANUFACTURER WAS PLACED IN THE NATIVE RIGHT VENTRICULAR OUTFLOW TRACT AT THE PROXIMAL PORTION OF THE STENT, WITH AN OUTCOME OF SEVERE VALVULAR INSUFFICIENCY AND A PERIVALVULAR LEAK. THIS DEVICE WAS THEN PLACED INSIDE THE FIRST VALVE, WITH AN OUTCOME OF MILD TO MODERATE PULMONARY INSUFFICIENCY AND A MILD PERIVALVULAR LEAK. UPON REMOVAL OF THE DELIVERY SYSTEM, THE VALVES AND STENT EMBOLIZED INTO THE RIGHT VENTRICLE. THE DEVICES WERE CAPTURED ON A BALLOON AND ADVANCED INTO POSITION AND DILATED, PENDING TRANSFER OF THE PATIENT TO AN OPERATING ROOM. SUBSEQUENT EMBOLIZATION OF THE DEVICES LED TO SUDDEN HYPOTENSION AND CARDIAC ARREST, TREATED WITH CARDIOPULMONARY RESUSCITATION AND EXTRACORPOREAL MEMBRANE OXYGENATION CANNULATION VIA FEMORAL ACCESS. THE REPORTED CAUSE OF DEATH WAS CARDIAC ARREST DUE TO EMBOLIZATION OF THE DEVICES. THE DEVICES REMAINED IMPLANTED, AS THE FAMILY DECLINED CONDUCTION OF AN AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662283 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB1018

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Death| R