BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 4122539 · Received September 26, 2014

    Report

    Report Number
    2025587-2014-00703
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 4, 2014
    Report Date
    January 2, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    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. PARAVALVULAR LEAK (PVL) CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR THE PRESENCE OF PRE-EXISTING PATIENT CONDITIONS, AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE. FROM THE REPORTED INFORMATION, IT IS LIKELY THAT THE CAUSE OF THE SUBSEQUENT DISLODGEMENT WAS THE EXTERNAL FORCE ON THE VALVE THAT OCCURRED DURING BALLOON AORTIC VALVULOPLASTY. HOWEVER, POTENTIAL COMPOUNDING FACTORS OF VALVE DISLODGEMENT COULD INCLUDE IMPROPER SIZING BETWEEN VALVE AND ANNULUS, IRREGULAR PATIENT ANATOMY, AND/OR INCOMPLETE FRAME EXPANSION. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. A SECOND VALVE WAS IMPLANTED SUCCESSFULLY, WITH MILD PVL BEING NOTED. A CONCLUSIVE CAUSE OF THE MILD PVL COULD NOT BE DETERMINED. MILD PVL HAS MINIMAL IMPACT ON THE PATIENT AND IS GENERALLY DEEMED AN ACCEPTABLE RESIDUAL CONDITION.

    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 FOLLOWING DEPLOYMENT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, MODERATE PARAVALVULAR LEAK (PVL) WAS NOTED. THE PHYSICIAN ELECTED TO ADDRESS THE PVL WITH BALLOON AORTIC VALVULOPLASTY (BAV), WHICH IN THE PROCESS DISLODGED THE VALVE FROM THE TARGET SITE. A SECOND VALVE WAS SUCCESSFULLY IMPLANTED VALVE-IN-VALVE, RESULTING IN MILD PVL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601003 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 Required Intervention