BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 4954093 · Received July 30, 2015

    Report

    Report Number
    3002648230-2015-00208
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    January 1, 2015
    Report Date
    July 7, 2015
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT APPROVED FOR DISTRIBUTION IN THE U.S. AND NOT SIMILAR TO A PRODUCT APPROVED FOR DISTRIBUTION IN THE U.S.;

    Additional Manufacturer Narrative · 1

    MEDTRONIC CRYOCATH WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: 990063-020-ACHIEVE MAPPING CATHETER. (B)(4).

    Description of Event or Problem · 1

    LIU J, KAUFMANN J, KRIATSELIS C, FLECK E, GERDS-LI J. OUTCOME OF CRYOBALLOON ABLATION FOR ATRIAL FIBRILLATION: MEDIUM-TERM FOLLOW-UP FROM A SINGLE CENTER. HERZ.2015;40(2):125-129. OBJECTIVE: WE ANALYZED THE MEDIUM-TERM FOLLOW-UP OF CRYOBALLOON ABLATION (CBA) FOR ATRIAL FIBRILLATION (AF) AND THE CLINICAL RISK FACTORS PREDICTING OUTCOME.METHODS: AF PATIENTS TREATED FOR THE FIRST TIME WITH CBA IN A 4.5-YEAR PERIOD WERE STUDIED RETROSPECTIVELY. PULMONARY VEIN ISOLATION (PVI) WAS ACHIEVED VIA A SINGLE CRYOBALLOON WITH DIAMETER OF 28 MM. LEFT ATRIAL DIAMETER (LAD) WAS MEASURED BY TRANSTHORACIC ECHOCARDIOGRAPHY. FAILURE OF CRYOABLATION TREATMENT WAS DEFINED AS DETECTION OF AN EPISODE OF AF, ATRIAL FLUTTER, OR ATRIAL TACHYCARDIA LASTING MORE THAN 30 S DURING THE 3-MONTH FOLLOW-UP. RESULTS: A TOTAL OF 212 PATIENTS WERE ENROLLED AND IN 87.7 % PATIENTS PVI WAS ACHIEVED BY CBA. THE COMPLICATION RATE WAS 2.83 %. THE MEAN FOLLOW-UP WAS 28 ± 15 MONTHS; IN 166 PATIENTS FOLLOW-UP WAS COMPLETE. THE RATE OF SUCCESSFUL TREATMENT FOR PRIMARY CBA WAS 45.8 %. THE PERCENTAGE OF PATIENTS WHO EXPERIENCED ATRIAL ARRHYTHMIA RECURRENCE IN THE FIRST 12 MONTHS WAS 84.44 %. PATIENTS IN WHOM TREATMENT FAILED HAD A LARGER LAD (47 ± 6 MM VS. 43 ± 5 MM, P <(><<)> 0.0001). THE KAPLAN-MEIER CURVE SHOWED THAT THE PATIENTS WITH LAD <(><<)> 45 MM HAD A HIGHER SUCCESS RATE THAN PATIENTS WITH LAD ? 45 MM [57.9 % (44/76) VS. 35.6 % (32/90), LOG RANK = 5.492, P = 0.019]. THE LAD [ODDS RATIO, OR = - 0.1053(0.303, 12.2040), P = 0.0005] WAS SHOWN IN LOGISTIC REGRESSION ANALYSIS TO BE INDEPENDENTLY PREDICTIVE OF CBA TREATMENT FAILURE. CONCLUSION: THE CBA PROCEDURE FOR AF PATIENTS IS SAFE AND EFFECTIVE. MOST ATRIAL ARRHYTHMIA RECURRENCES OCCURRED DURING THE FIRST 12 MONTHS AFTER CBA. THE LAD CAN INDEPENDENTLY PREDICT FAILURE OF CBA TREATMENT. THE LITERATURE PUBLICATION REPORTS THE FOLLOWING COMPLICATIONS: THREE PATIENTS WITH PHRENIC NERVE PALSY (PNP) - TWO RESOLVED WHEN CRYOABLATION WAS STOPPED, ONE RESOLVED SEVEN MONTHS AFTER PROCEDURE; ONE PATIENT WITH PERICARDIAL EFFUSION WHICH RESOLVED SPONTANEOUSLY; AND TWO PATIENTS WITH TRANSIENT ISCHEMIC ATTACK (TIA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496507 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF281

    Patients

    Seq Age Sex Outcome Treatment
    1