BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 3841401 · Received May 30, 2014

    Report

    Report Number
    2025587-2014-00337
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 8, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE EVENT INFORMATION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. THE REPORTED VALVE IMPLANT DEPTH IS CONSIDERED LOW PER THE COREVALVE INSTRUCTIONS FOR USE. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: BASED ON THE INFORMATION PROVIDED, THE REPORTED PARAVALVULAR LEAK (PVL) THAT REQUIRED REINTERVENTION COULD POSSIBLY BE RELATED TO PATIENT ANATOMY AND/OR IMPLANT POSITION. POSITIONING IS DEPENDENT ON PATIENT ANATOMY AS WELL AS USER TECHNIQUE. POTENTIAL FACTORS THAT CAN INFLUENCE IMPLANT POSITION INCLUDE TENSION APPLIED ON THE DELIVERY CATHETER SYSTEM (DCS) DURING POSITIONING, CALCIFICATION LEVELS IN THE NATIVE VESSEL AND COMPLIANCE OF THE AORTA AND NATIVE VESSELS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT EFFECTS REPORTED. THE ROOT CAUSE FOR THIS REPORT COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. (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 FIRST VALVE (B)(4) WAS IMPL ANTED AT A DEPTH OF 8MM AND FOUND TO HAVE MODERATE PARAVALVULAR LEAK. A SECOND VALVE (B)(4) WAS IMPLANTED VALVE IN VALVE IMPROVING THE PARAVALVULAR LEAK TO MILD. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318004 COREVALVE 31MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-31-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention