BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 3841560 · Received May 30, 2014

    Report

    Report Number
    2025587-2014-00340
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    January 7, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S SPOUSE THAT THE PARAVALVULAR LEAK WAS DUE TO INCOMPLETE FRAME EXPANSION SECONDARY TO A SEVERE CALCIFIC FORMATION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED FOR THIS VALVE AND THE DELIVERY CATHETER SYSTEM (DCS) AND SHOWED THAT THESE PRODUCTS MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. FROM THE AVAILABLE INFORMATION A CONCLUSIVE CAUSE FOR THE FRAME LOOP RELEASE DIFFICULTY COULD NOT BE DETERMINED. POTENTIAL FACTORS INFLUENCING THE DIFFICULTY INCLUDE ORIENTATION OF THE DCS TAB/FRAME LOOP AGAINST THE PATIENT¿S ANATOMY AND THE ANGLE OF DEPLOYMENT IN WHICH THE DCS TAB IS ROTATED IN THE FRAME LOOP. THIS ISSUE IS A KNOWN POTENTIAL RISK OF THE COREVALVE SYSTEM, AND THE INSTRUCTIONS FOR USE (IFU) PROVIDE GUIDANCE IN RELEASING THE FRAME LOOP FROM THE DELIVERY SYSTEM. PARAVALVULAR LEAK (PVL) CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. IN THIS CASE, THE CAUSE OF THE PVL IS THE SUBOPTIMAL POSITION OF THE VALVE DUE TO THE DIFFICULTY TO DEPLOY. THE ISSUE WAS REDUCED TO MILD PVL AFTER THE IMPLANT OF A SECOND VALVE. IT WAS REPORTED THAT THE FRAME MAY HAVE BEEN UNABLE TO COMPLETELY EXPAND DUE TO A SEVERE CALCIFIC FORMATION OF THE PATIENT¿S ANATOMY; HOWEVER, A CONCLUSIVE CAUSE IS UNABLE TO BE DETERMINED. A 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: FOLLOWING COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S SPOUSE THAT THE PARAVALVULAR LEAK WAS DUE TO INCOMPLETE FRAME EXPANSION SECONDARY TO A SEVERE CALCIFIC FORMATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING DEPLOYMENT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THERE WAS DIFFICULTY RELEASING THE FRAME LOOPS FROM THE DELIVERY CATHETER SYSTEM (DCS). THE DCS WAS PUSHED FORWARD AND TWISTED, RELEASING ONE TAB. WHILE TRYING TO RELEASE THE SECOND TAB, THE DCS WAS PULLED BACKWARDS, PULLING THE VALVE OUT OF THE ANNULUS, RESULTING IN MODERATE PARAVALVULAR LEAK (PVL). A BALLOON AORTIC VALVULOPLASTY (BAV) WITH A 26MM BALLOON WAS PERFORMED AND DID NOT RESOLVE THE PVL. ADDITIONALLY, THERE WAS A NARROW DIASTOLIC GRADIENT. A SECOND VALVE (31MM) WAS DEPLOYED, VALVE IN VALVE AND THE PVL DECREASED TO MILD AND THE DIASTOLIC GRADIENT IMPROVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318391 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 00079 YR Required Intervention (B)(4)