BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER

    MDR report key: 18622950 · Received February 1, 2024

    Report

    Report Number
    3008452825-2024-00069
    Event Type
    Death
    Date Received
    February 1, 2024
    Report Date
    March 6, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CARDIAC PERFORATION AND BLEEDING REMAINS UNKNOWN. PER THE IFU, VASCULAR PERFORATION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURE REF: 3008452825-2024-00068. THE FOLLOWING WAS PUBLISHED IN THE HEART RHYTHM 20.12: 1708-1717. ELSEVIER B.V. (DEC 2023) IN AN ARTICLE TITLED "CRYOTHERMAL ENERGY DEMONSTRATES SHORTER ABLATION TIME AND LOWER COMPLICATION RATES COMPARED WITH RADIOFREQUENCY IN SURGICAL HYBRID ABLATION FOR RECURRENT VENTRICULAR TACHYCARDIA"; BRADFIELD, JASON S; HTTP://DX.DOI.ORG/10.1016/J.HRTHM.2023.08.036. BETWEEN 2009 AND 2022, 43 PATIENTS UNDERWENT EITHER A CRYOTHERMAL (N 5 17) OR A RADIOFREQUENCY (N 5 26) HYBRID EPICARDIAL ABLATION PROCEDURE WITH DIRECT SURGICAL ACCESS. BOTH GROUPS WERE SIMILARLY MATCHED FOR AGE, SEX, ETIOLOGY OF VT, AND COMORBIDITIES WITH A HIGH BURDEN OF REFRACTORY VT DESPITE PREVIOUS ENDOCARDIAL AND/OR PERCUTANEOUS EPICARDIAL ABLATION PROCEDURES. THE SURGICAL ACCESS SITE WAS LATERAL THORACOTOMY (76.5%) IN THE CRYOTHERMAL ABLATION GROUP COMPARED WITH LATERAL THORACOTOMY (42.3%) AND SUBXIPHOID APPROACH (38.5%) IN THE RADIOFREQUENCY GROUP, WITH THE REMAINDER IN BOTH GROUPS PERFORMED VIA MEDIAN STERNOTOMY. THE ABLATION TIME WAS SIGNIFICANTLY SHORTER IN THOSE UNDERGOING CRYOTHERMAL ABLATION VS RADIOFREQUENCY ABLATION (11.54 6 15.5 MINUTES VS 48.48 6 23.6 MINUTES; P,.001). THERE WERE NO COMPLICATIONS IN THE CRYOTHERMAL ABLATION GROUP COMPARED WITH 6 PATIENTS WITH COMPLICATIONS IN THE RADIOFREQUENCY GROUP. RECURRENT VT EPISODES AND ALL-CAUSE MORTALITY WERE SIMILAR IN BOTH GROUPS. COMPLICATIONS PRIMARILY COMPRISED BLEEDING AND ALL OCCURRED IN LATERAL THORACOTOMY ACCESS. ONE PATIENT HAD A PERICARDIAL HEMORRHAGE RESULTING IN DEATH THE FOLLOWING DAY. TWO PATIENTS WITH PERICARDIAL HEMORRHAGE REQUIRING BLOOD TRANSFUSION, ONE PATIENT WITH A STERNAL INCISIONAL HEMATOMA REQUIRING EVACUATION AND ONE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WHICH REQUIRED SURGICAL REOPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073131 FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death