BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER

    MDR report key: 18890905 · Received March 12, 2024

    Report

    Report Number
    3008452825-2024-00131
    Event Type
    Injury
    Date Received
    March 12, 2024
    Report Date
    April 24, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    FOLLOW UP REPORT NEEDED TO INCLUDE UPDATED EVENT DESCRIPTION. THE FOLLOWING WAS PUBLISHED IN JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY 35.2: 317-327. JOHN WILEY AND SONS INC. (FEB 2024) "MYOCARDIAL INJURY AND INFLAMMATION FOLLOWING PULSED-FIELD ABLATION AND VERY HIGH-POWER SHORT-DURATION ABLATION FOR ATRIAL FIBRILLATION"; POPA, MIRUNA A. WE INCLUDED 179 PATIENTS WITH PAROXYSMAL AF RECEIVING FIRST-TIME PVI WITH DIFFERENT ABLATION TECHNOLOGIES: STANDARD RFA, POWER-CONTROLLED HPSD, TEMPERATURE-CONTROLLED HPSD, AND PFA (BIPHASIC, BIPOLAR WAVEFORM, N = 35). HIGH-SENSITIVITY CARDIAC TROPONIN T (HS-CTNT), CREATINE KINASE (CK), CK MB ISOFORM (CK-MB), AND WHITE BLOOD CELL (WBC) COUNT WERE DETERMINED BEFORE AND AFTER ABLATION. BASELINE CHARACTERISTICS WERE WELL-BALANCED BETWEEN GROUPS. POSTABLATION HS-CTNT RELEASE WAS SIGNIFICANTLY HIGHER WITH PFA, HPSD-70W, AND HPSD-90W THAN WITH STANDARD RFA. CK AND CK-MB RELEASE WAS INCREASED WITH PFA BY 3.4-FOLD AND 5.8-FOLD, RESPECTIVELY, AS COMPARED TO STANDARD RFA. PFA WAS ASSOCIATED WITH THE LOWEST ELEVATION IN WBC, AS COMPARED TO STANDARD RFA, HPSD-70W, AND HPSD-90W. CONCLUSION: AMONG THE FOUR INVESTIGATED ABLATION TECHNOLOGIES, PFA WAS ASSOCIATED WITH THE HIGHEST MYOCARDIAL INJURY AND THE LOWEST INFLAMMATORY REACTION. 1 TIA WAS REPORTED. DURING THE CASE IN WHICH A TIA OCCURRED, THE PHYSICIAN REPORTS THAT THERE WAS NOT ANYTHING DURING THE ABLATION PROCEDURE THAT WAS NOT AS EXPECTED. THE PATIENT EXPERIENCED TRANSIENTLY DISTURBED VISION ON ONE EYE. THE PATIENT WAS CLINICALLY EXAMINED BY A NEUROLOGIST. COMPUTED TOMOGRAPHY AND MRI WERE PERFORMED AND TIA WAS DIAGNOSED BY THE NEUROLOGIST. SYMPTOMS RESOLVED SPONTANEOUSLY; NO TREATMENT WAS ADMINISTERED. ORAL ANTICOAGULATION WAS CONTINUED UNTIL 3 MONTHS POST PROCEDURE. SINCE THE REPORTED EVENT, THE PATIENT HAS NOT EXPERIENCED ANY PERSISTENT NEUROLOGICAL DEFICIT. THE PATIENT HAD NO MEDICAL HISTORY OF TIA/CVA. COMPUTED TOMOGRAPHY WAS PERFORMED TO RULE OUT LA THROMBUS BEFORE THE PROCEDURE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY 35.2: 317-327. JOHN WILEY AND SONS INC. (FEB 2024) "MYOCARDIAL INJURY AND INFLAMMATION FOLLOWING PULSED-FIELD ABLATION AND VERY HIGH-POWER SHORT-DURATION ABLATION FOR ATRIAL FIBRILLATION"; POPA, MIRUNA A. WE INCLUDED 179 PATIENTS WITH PAROXYSMAL AF RECEIVING FIRST-TIME PVI WITH DIFFERENT ABLATION TECHNOLOGIES: STANDARD RFA, POWER-CONTROLLED HPSD, TEMPERATURE-CONTROLLED HPSD, AND PFA (BIPHASIC, BIPOLAR WAVEFORM, N = 35). HIGH-SENSITIVITY CARDIAC TROPONIN T (HS-CTNT), CREATINE KINASE (CK), CK MB ISOFORM (CK-MB), AND WHITE BLOOD CELL (WBC) COUNT WERE DETERMINED BEFORE AND AFTER ABLATION. BASELINE CHARACTERISTICS WERE WELL-BALANCED BETWEEN GROUPS. POSTABLATION HS-CTNT RELEASE WAS SIGNIFICANTLY HIGHER WITH PFA, HPSD-70W, AND HPSD-90W THAN WITH STANDARD RFA. CK AND CK-MB RELEASE WAS INCREASED WITH PFA BY 3.4-FOLD AND 5.8-FOLD, RESPECTIVELY, AS COMPARED TO STANDARD RFA. PFA WAS ASSOCIATED WITH THE LOWEST ELEVATION IN WBC, AS COMPARED TO STANDARD RFA, HPSD-70W, AND HPSD-90W. CONCLUSION: AMONG THE FOUR INVESTIGATED ABLATION TECHNOLOGIES, PFA WAS ASSOCIATED WITH THE HIGHEST MYOCARDIAL INJURY AND THE LOWEST INFLAMMATORY REACTION. 1 TIA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221714 FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL AFD0393

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening