BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3726649 · Received April 4, 2014

    Report

    Report Number
    2025587-2014-00182
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 13, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND WILL NOT BE RETURNED. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. (B)(4).

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT HYPOTENSION WAS NOTED DURING THE DEPLOYMENT OF THE FIRST VALVE. THE VALVE WAS NOT ABLE TO BE IMPLANTED AND WAS REMOVED. THE PATIENT WAS TREATED WITH MEDICATION, WHICH CAUSED SOME REBOUND HYPERTENSION. A SECOND VALVE WAS SUCCESSFULLY IMPLANTED. POST PROCEDURE, ENZYMES WERE ELEVATED AND ST SEGMENT ELEVATION WAS NOTED ON THE EKG. THE PATIENT WAS TREATED WITH MEDICATION. SUBSEQUENTLY, THE PATIENT HAD A PERMANENT PACEMAKER IMPLANTED DUE TO THE CONDUCTION DISTURBANCE (BBB) TWO DAYS POST IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT ONE DAY POST INDEX PROCEDURE THE PATIENT WAS NOTED TO SUFFER FROM CARDIOGENIC SHOCK. THE PATIENT SHOWED SIGNS OF HYPOPERFUSION, ACIDOSIS AND LOW URINE OUTPUT WHICH WAS DIRECTLY RELATED TO THE SEVERE PVL. THE THIRD VALVE WAS IMPLANTED THAT DAY AND THE PATIENT RECOVERED. TWO DAYS POST INITIAL VALVE IMPLANT COMPLETE HEART BLOCK (CHB) WAS NOTED. ELECTROPHYSIOLOGY (EP) WAS CONSULTED AND ADVISED PERMANENT PACEMAKER PLACEMENT WHICH WAS IMPLANTED TWELVE DAYS POST INDEX PROCEDURE. (B)(4). CORRECTION: THE DATE OF THE PACER IMPLANT HAS BEEN CORRECTED FROM THE PREVIOUS REPORT (TWO DAYS POST TO 12 DAYS POST IMPLANT).

    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. POSITIONING DIFFICULTIES ARE OFTEN INFLUENCED BY PATIENT ANATOMY AND USER TECHNIQUE, BUT A ROOT CAUSE OF THE LOW DEPLOYMENT DEPTH COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THE DEVICE WAS RETRIEVED AND ANOTHER DEVICE WAS IMPLANTED WITH RESULTANT SEVERE PARAVALVULAR LEAK (PVL) DUE TO THE POSITIONING. A SECOND VALVE WAS IMPLANTED WITH MILD PVL. A MILD PVL HAS MINIMAL IMPACT ON A 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 DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE (SN(B)(4)), THE VALVE WAS DEPLOYED TOO DEEP. AS THE VALVE WAS BEING MOVED INTO THE OPTIMAL IMPLANT POSITION WITH THE DELIVERY CATHETER SYSTEM (DCS), THE VALVE MOVED OUT OF THE ANNULUS INTO THE ASCENDING AORTA. THE VALVE WAS RETRIEVED THROUGH THE SHEATH AND DISCARDED. A SECOND VALVE (SN (B)(4)) WAS IMPLANTED SUPRA-ANNULAR WITH RESULTING MODERATE PARAVALVULAR LEAK (PVL). ONE DAY POST-IMPLANT THE PVL HAD INCREASED TO SEVERE. THE VALVE WAS SNARED AND MOVED INTO THE ASCENDING AORTA. ANOTHER VALVE (SN B143003) WAS IMPLANTED, WITH RESULTING MILD PVL. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204075 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-640

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention