BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARBOMEDICS ANNULOPLASTY RING

    MDR report key: 12619221 · Received October 12, 2021

    Report

    Report Number
    3005687633-2021-00163
    Event Type
    Death
    Date Received
    October 12, 2021
    Report Date
    November 13, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    KRH
    PMA / PMN Number
    K992056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE DEVICE WAS NOT EXPLANTED AND THE SERIAL NUMBER IS UNKNOWN, NO DEVICE INVESTIGATION IS POSSIBLE AT THIS TIME. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO ESTABLISH A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT. IT IS POSSIBLE, IN AGREEMENT WITH THE MEDICAL JUDGMENT RECEIVED, THAT THE PATIENT-SPECIFIC CONDITIONS CONTRIBUTED TO THE EVENT REPORTED. SINCE, HOWEVER, NO INVESTIGATION ON THE DEVICE WAS POSSIBLE, THE ROOT CAUSE REMAINS UNKNOWN AT THIS TIME. SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE IN THE FUTURE, A FOLLOW UP REPORT WILL BE PROVIDED. H3 OTHER TEXT : DEVICE NOT EXPLANTED.

    Additional Manufacturer Narrative · 0

    UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ON THIS EVENT THROUGH THE PAPER "THROMBOEMBOLIC COMPLICATIONS OF ANNULOPLASTY RINGS" BY RATNASARI PADANG, ET AL. THE PUBLICATION DESCRIBES 8 PATIENTS PRESENTING WITH NEW THROMBOEMBOLIC COMPLICATIONS FOLLOWING RING ANNULOPLASTY REPAIR, HIGHLIGHTING THE VARIABLE CLINICAL AND IMAGING PRESENTATIONS OF THIS CONDITION. ONE OF THESE PATIENTS RECEIVED AN ANNULOFLEX RING 32MM (AF-832) IN 2009. THE PATIENT RECEIVED POST-OPERATIVE ANTICOAGULATION TREATMENT (WARFARIN) FOR A FEW WEEKS AFTER THE CARBOMEDICS ANNULOFLEX RING IMPLANT. THE PATIENT HAD RECURRENT RECURRENT TRANSIENT ISCHEMIC ATTACK OR STROKE 32 MONTHS POST OP, AND THE ECHO SHOWED A MASS ATTACHED TO THE ANNULOPLASTY RING. THE PATIENT HAD RECURRENT EMBOLIC EPISODE DESPITE OF WARFARIN THERAPY. PER ADDITIONAL INFORMATION RECEIVED, THE DEVICE WAS NOT EXPLANTED BUT THE PATIENT DECEASED DUE TO STROKE IN 2012. THE PATIENT'S BASELINE CONDITIONS INCLUDED ASTHMA, HYPERTENSION, HYPERLIPIDEMIA. LIMITED RECORD IS REPORTEDLY AVAILABLE DUE TO TRANSITION TO DIFFERENT EMR PLATFORM. BASED ON THE MEDICAL JUDGMENT RECEIVED, THE RELATIONSHIP WITH THE THROMBOEMBOLIC EVENT AND THE DEVICE COULD NOT BE DEFINITIVELY STATED. HOWEVER, IT IS BELIEVED THAT THERE HAS TO BE PATIENT FACTOR ALSO THAT CONTRIBUTE TO ITS DEVELOPMENT, RATHER THAN SIMPLY DUE TO THE DEVICE ITSELF.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ON THIS EVENT THROUGH THE PAPER "THROMBOEMBOLIC COMPLICATIONS OF ANNULOPLASTY RINGS" BY RATNASARI PADANG, ET AL. THE PUBLICATION DESCRIBES 8 PATIENTS PRESENTING WITH NEW THROMBOEMBOLIC COMPLICATIONS FOLLOWING RING ANNULOPLASTY REPAIR, HIGHLIGHTING THE VARIABLE CLINICAL AND IMAGING PRESENTATIONS OF THIS CONDITION. ONE OF THESE PATIENTS RECEIVED A CARBOMEDICS 32MM RING. THE PATIENT HAD RECURRENT RECURRENT TRANSIENT ISCHEMIC ATTACK OR STROKE 32 MONTHS POST OP, AND THE ECHO SHOWED A MASS ATTACHED TO THE ANNULOPLASTY RING. DUE TO RECURRENT EMBOLIC EPISODE DESPITE OF WARFARIN THERAPY, THE PATIENT UNDERWENT REDO MITRAL VALVE SURGERY. THE PATIENT RECEIVED POST-OPERATIVE ANTICOAGULATION TREATMENT (WARFARIN) FOR A FEW WEEKS AFTER THE CARBOMEDICS RING IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513993 CARBOMEDICS ANNULOPLASTY RING MITRAL ANNULOPLASTY RING KRH CORCYM S.R.L. TBD

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| D