BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE 29MM AORTIC VALVE

    MDR report key: 4277546 · Received November 25, 2014

    Report

    Report Number
    2025587-2014-00949
    Event Type
    Death
    Date Received
    November 25, 2014
    Date of Event
    November 3, 2014
    Report Date
    July 29, 2015
    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
    OTHER

    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 REPORTED CLINICAL OBSERVATION OF REGURGITATION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. REGURGITATION CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR THE PRESENCE OF PRE-EXISTING PATIENT CONDITIONS, AND IS MOST LIKELY DUE TO VALVE POSITIONING. HOWEVER, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE LIMITED INFORMATION AVAILABLE. THE REPORT OF HYPOTENSION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. HYPOTENSION IS A KNOWN POTENTIAL ADVERSE EFFECT PER COREVALVE INSTRUCTIONS FOR USE (IFU). IT IS AN EFFECT THAT IS HIGHLY DEPENDENT ON THE PATIENT'S PRE-PROCEDURAL CONDITION AND CAN OCCUR DESPITE A NORMALLY-FUNCTIONING DEVICE OR MODEL IMPLANT PROCEDURE. THE REPORT OF PATIENT EXPIRATION AT IMPLANT WAS ASCERTAINED AS BEING RELATED TO THE PROCEDURE, SPECIFICALLY BECAUSE THE PATIENT WAS UNABLE TO TOLERATE THE DROP IN PRESSURE FOR THE PERIOD OF TIME FOR THE IMPLANT PROCEDURE. AS NEITHER AN AUTOPSY NOR AN EXPLANT WAS PERFORMED, A CONCLUSIVE ASSESSMENT OF THE RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE COULD NOT BE REACHED. A PROCEDURE- OR VALVE-RELATED DEATH IS AN INHERENT RISK WHEN THE PATIENT CONDITION IS SUCH THAT A PERCUTANEOUS AORTIC VALVE (PAV) IS NEEDED TO SUSTAIN CARDIAC FUNCTION, AND IT CAN OCCUR DESPITE AN IDEAL IMPLANT PROCEDURE OR DEVICE FUNCTIONALITY. NO ALLEGATIONS WERE MADE AGAINST THE DEVICE, AND THERE WAS NO INDICATION THAT A MALFUNCTION OR MISUSE CONTRIBUTED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE .

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT SEVERE REGURGITATION WAS NOTED DURING THE PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) IN PREPARATION FOR IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE. THE TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED IN A SLIGHTLY HIGH POSITION, WITH POST-DEPLOYMENT OBSERVATIONS OF AN UNSPECIFIED GRADE OF AORTIC REGURGITATION AND LOW AORTIC PRESSURE. AS A SECOND VALVE WAS BEING PREPARED FOR IMPLANT, THE PATIENT'S PRESSURE APPEARED TO IMPROVE. HOWEVER, AS THE PHYSICIAN WAS CLOSING THE INCISION SITE, THE PATIENT'S AORTIC PRESSURE DROPPED AGAIN AND SUBSEQUENTLY COULD NOT BE STABILIZED. SUBSEQUENTLY THE PATIENT PASSED AWAY DUE TO OPEN AORTIC INSUFFICIENCY ORIGINATING FROM THE PRE-DILATATION OF THE ANNULUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764859 COREVALVE 29MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-29-AOA-US

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Death