BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 4103194 · Received September 19, 2014

    Report

    Report Number
    2025587-2014-00680
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    December 5, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEPARATE REPORTS HAVE BEEN FILED ON THE OTHER TWO VALVES DEPLOYED DURING THE PROCEDURE. THE PRODUCT HAS BEEN RETURNED AND ANALYSIS IS IN PROGRESS. UPON COMPLETION OF ANALYSIS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE VALVE WAS DISCOLORED, SHOWING EVIDENCE OF BLOOD CONTACT. THE FRAME WAS INTACT WITH NO EVIDENCE OF DEFORMATION. ALL LEAFLETS WERE IN THE CLOSED POSITION, WITH A GAP BETWEEN THE COAPTIVE RIDGES OF LEAFLETS 2 AND 3. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE, POSSIBLY DUE TO BLOOD CONTACT AND/OR THE DECONTAMINATION PROCESS. ALL LEAFLETS WERE WRINKLED, SHOWING EVIDENCE THE VALVE WAS SET IN THE CRIMPED POSITION FOR AN UNKNOWN PERIOD OF TIME. ALL LEAFLETS WERE INTACT. ALL COMMISSURES WERE INTACT.

    Additional Manufacturer Narrative · 1

    THE VENTRICULAR FIBRILLATION AND SEVERE MITRAL VALVE REGURGITATION THAT OCCURRED MOST LIKELY RESULTED FROM THE FIRST DEVICE AND/OR THE SECOND DEVICE BEING PUSHED DOWN INTO THE VENTRICLE. ANALYSIS OF THIS RETURNED DEVICE SHOWED NO ANOMALIES. A DEVICE HISTORY RECORD REVIEW WAS NOT CONDUCTED, AS THE REPORTED INFORMATION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. THE DELIVERY CATHETER SYSTEM LOT HISTORY RECORD WAS REVIEWED AND SHOWED THAT DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. FROM THE AVAILABLE INFORMATION A CONCLUSIVE CAUSE FOR THE CLINICAL OBSERVATION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS TRANSCATHETER BIOPROSTHETIC VALVE WAS THE THIRD OF THREE VALVES THAT WERE SURGICALLY REMOVED AFTER UNSUCCESSFUL ATTEMPTED IMPLANT. AS THIS VALVE WAS BEING ADVANCED AND DEPLOYED, IT PUSHED TWO PREVIOUSLY ATTEMPTED VALVES INTO LOWER POSITIONS. AS A RESULT OF THE FIRST VALVE BEING PUSHED FURTHER INTO THE VENTRICLE (RESULTING IN VENTRICULAR FIBRILLATION) AND OBSTRUCTING ONE OF THE NATIVE MITRAL VALVE LEAFLETS (RESULTING IN SEVERE MITRAL REGURGITATION), DEFIBRILLATION, CARDIOPULMONARY RESUSCITATION, AND CARDIOPULMONARY BYPASS WERE INITIATED. THE PATIENT WAS THEN CONVERTED TO AN OPEN-HEART PROCEDURE TO REMOVE THE THREE VALVES AND IMPLANT ANOTHER MANUFACTURER¿S BIOPROSTHETIC AORTIC HEART VALVE. THREE DAYS POST-OPERATIVE THE PATIENT DIED. THE CAUSE OF DEATH WAS STATED AS MULTI-ORGAN FAILURE. THE PHYSICIAN DID NOT ALLEGE OR REFUTE THAT THE DEATH MAY HAVE BEEN RELATED TO THE DEVICES OR IMPLANT ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581555 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-943

    Patients

    Seq Age Sex Outcome Treatment
    1 00092 YR Death| H| R DCS-C4-18FR, 0007122562