BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 26MM AORTIC VALVE

    MDR report key: 4090198 · Received September 15, 2014

    Report

    Report Number
    2025587-2014-00665
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 22, 2014
    Report Date
    March 13, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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. THE MIGRATION OF THE VALVE IS LIKELY DUE TO UNDER-EXPANSION OF THE FRAME. OTHER POTENTIAL FACTORS THAT CAN INFLUENCE VALVE MIGRATION INCLUDE CALCIFICATION LEVELS IN THE NATIVE VESSEL, COMPLIANCE OF THE AORTA AND NATIVE VESSELS, A SIZE MISMATCH BETWEEN THE DEVICE AND PATIENT ANATOMY, AND OTHER FACTORS. IMAGES FROM THE PROCEDURE CONFIRM THE REPORT THAT THE VALVE FRAME INFLOW AREA WAS NOT FULLY EXPANDED AT 2/3 DEPLOYMENT AND WAS MORE FULLY EXPANDED AFTER DEPLOYMENT DURING THE FINAL ANGIOGRAM FRAME, AFTER THE FRAME HAD MOVED TO A DIFFERENT LOCATION. THIS INFORMATION REAFFIRMS THE REPORTED INFORMATION THAT THE FRAME UNDER-EXPANSION, AND THEREFORE THE VALVE MIGRATION, WAS LIKELY CAUSED BY THE HEAVY CALCIFICATION OF THE NATIVE ANATOMY. A SECOND VALVE WAS IMPLANTED SUCCESSFULLY, WITH A TRACE AMOUNT OF PVL NOTED. PARAVALVULAR LEAK CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS, AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE LIMITED INFORMATION AVAILABLE. A MILD PVL HAS MINIMAL IMPACT ON THE PATIENT AND IS GENERALLY DEEMED AN ACCEPTABLE RESIDUAL CONDITION.

    Additional Manufacturer Narrative · 1

    WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS TWO-THIRDS DEPLOYED AT A DEPTH OF 2MM ON THE NON-CORONARY SIDE AND 4MM ON THE LEFT CORONARY SIDE. THE VALVE WAS UNABLE TO FULLY EXPAND DUE TO HEAVY CALCIFICATION ON THE NATIVE LEAFLETS. AT FINAL DEPLOYMENT, THE VALVE HAD MOVED SLIGHTLY, BUT WAS STILL WITHIN THE ANNULUS. AT THE TIME OF THE FINAL ANGIOGRAM, THE VALVE FRAME WAS MORE FULLY EXPANDED BUT THE DEVICE HAD MIGRATED ABOVE THE NON-CORONARY CUSP. A SNARE WAS USED TO MOVE THE VALVE INTO THE ASCENDING AORTA. A SECOND VALVE WAS THEN IMPLANTED. A TRACE AMOUNT OF PARAVALVULAR LEAK WAS NOTED AFTER IMPLANT. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568598 COREVALVE 26MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-26-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention