BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3790359 · Received May 5, 2014

    Report

    Report Number
    2025587-2014-00259
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. PARAVALVULAR LEAK CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. IN THIS CASE, THE REPORTED INFORMATION INDICATED POSITIONING TOO LOW AND INACCURATE DELIVERY, WHICH ARE OFTEN INFLUENCED BY PATIENT ANATOMY AND USER TECHNIQUE, AND COULD HAVE CAUSED/CONTRIBUTED TO THE PARAVALVULAR LEAK, BUT A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THE ISSUE WAS SUCCESSFULLY RESOLVED THROUGH IMPLANT OF A THIRD VALVE. A REVIEW OF THE LOT HISTORY RECORD FOR THE DCS LOT NUMBER 0006957166 FOUND THE DEVICE TO BE BUILT TO SPECIFICATION AND MET ALL INSPECTION AND ACCEPTANCE CRITERIA PRIOR TO PRODUCT RELEASE. IT WAS ALSO REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PATIENT EXHIBITED VENTRICULAR TACHYCARDIA, WHICH IS A KNOWN POTENTIAL ADVERSE EVENT DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU). CONDUCTION DISTURBANCES, INCLUDING THE COMPLETE HEART BLOCK REPORTED FOR THIS EVENT, ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE (OPEN OR CATHETER-BASED) AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE IMPLANT OF A PERMANENT PACEMAKER (WITH THE RISK-BENEFIT RATIO IN FAVOR OF IMPLANT OF THE PERCUTANEOUS AORTIC VALVE). IN THIS CASE, A BI-VENTRICULAR ICD DESIGNED TO PROVIDE PACING AND DEFIBRILLATION THERAPIES WAS IMPLANTED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CAUSE OF THESE EVENTS WAS RELATED TO A FAILURE OF THE DEVICE TO MEET SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. SEPARATE REPORTS HAVE BEEN FILED ON THE ADDITIONAL VALVES IMPLANTED. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INCORRECTLY INDICATED THE SECOND VALVE WAS IMPLANTED AT A DEPTH TWO MILLIMETERS HIGHER THAN THE FIRST VALVE; THE SECOND VALVE WAS IMPLANTED AT A DEPTH OF TWO MILLLIMETERS, APPROXIMATELY 12-14 MILLIMETERS HIGHER THAN THE FIRST VALVE.

    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 THREE TRANSCATHETER BIOPROSTHETIC VALVES WERE IMPLANTED TO RESOLVE THE PATIENT¿S MODERATE/SEVERE PARAVALVULAR LEAK. IN ADDITION, A BI-VENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED AFTER THE THIRD VALVE IMPLANT TO RESOLVE COMPLETE HEART BLOCK AND A LOW EJECTION FRACTION. THIS 31MM VALVE WAS REPORTEDLY IMPLANTED IN A DEEP LOCATION; AN ECHOCARDIOGRAM AND AN ANGIOGRAM DOCUMENTED MODERATE/SEVERE PARAVALVULAR LEAK (PVL). BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 28MM BALLOON, WITH NO CHANGE TO THE PVL. A SECOND 31MM BIOPROSTHETIC VALVE WAS IMPLANTED VALVE-IN-VALVE AT A LOCATION TWO MM HIGHER, WITH ECHOCARDIOGRAM AND ANGIOGRAM DOCUMENTING CONTINUED MODERATE/SEVERE PVL. BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 28MM BALLOON, WITH NO CHANGE TO THE PVL. A 29 MM VALVE WAS THEN IMPLANTED VALVE-IN-VALVE WITH RESULTANT TRACE PVL OBSERVED VIA ECHOCARDIOGRAM AND ANGIOGRAM. DURING THE IMPLANT PROCEDURE, THE PATIENT EXHIBITED VENTRICULAR TACHYCARDIA, WHICH WAS SUCCESSFULLY CONVERTED WITH ONE DEFIBRILLATION. FOLLOWING THE VT CONVERSION, THE PATIENT REQUIRED TEMPORARY PACING DUE TO COMPLETE HEART BLOCK (CHB). A BI-VENTRICULAR ICD SUBSEQUENTLY WAS IMPLANTED TO RESOLVE THE CHB AND AN EJECTION FRACTION OF 20%. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266624 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-3143

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention