BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT INTRODUCER, UNKNOWN

    MDR report key: 15872819 · Received November 28, 2022

    Report

    Report Number
    3008452825-2022-00702
    Event Type
    Injury
    Date Received
    November 28, 2022
    Report Date
    January 18, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION PROVIDED BY THE PHYSICIAN CONFIRMS THAT THE ADVERSE EVENT WAS NOT RELATED TO AN ABBOTT DEVICE, MAKING THIS EVENT NOT REPORTABLE.

    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. FURTHER INFORMATION PROVIDED BY THE PHYSICIAN CONFIRMS THAT THE ADVERSE EVENT WAS NOT RELATED TO AN ABBOTT DEVICE, MAKING THIS EVENT NOT REPORTABLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF HEART AND VESSELS, © SPRINGER JAPAN KK, PART OF SPRINGER NATURE 2022, "COMPARISON OF OUTCOMES WITH LOW-POWER LONG DURATION VERSUS HIGH-POWER SHORT DURATION OF ABLATION: THE ROLE OF THE ACUTE CHANGE IN SINUS RHYTHM AFTER THE ABLATION AS A PREDICTOR OF LONG-TERM SUCCESS", VASSALLO, FABRICIO. RECEIVED: 16 DECEMBER 2021 / ACCEPTED: 25 MARCH 2022 HTTPS://DOI.ORG/10.1007/S00380-022-02066-3. DIFFERENT RESULTS ARE DESCRIBED AFTER ATRIAL FIBRILLATION ABLATION AND MULTIPLE PREDICTORS OF RECURRENCE ARE WELL ESTABLISHED. EVALUATE AND ANALYZE IF HEART RATE INCREASE (HRI) DURING A FIRST ATRIAL FIBRILLATION (AF) ABLATION WITH LOW-POWER LONG-DURATION (LPLD) AND SUBSEQUENTLY WITH HIGH-POWER SHORT-DURATION (HPSD) CAN IMPACT. RETROSPECTIVELY ANALYZED 340 CONSECUTIVE PATIENTS (PTS) UNDERGOING FIRST AF ABLATION. THERE WERE 158 PTS IN LPLD GROUP: 113 (71.5%) PAROXYSMAL AF WITH ABLATION WITH A POWER OF 30/20 W, ON ANTERIOR AND POSTERIOR LEFT ATRIAL (LA) WALL, RESPECTIVELY, AND CONTACT FORCE OF 10¿30G FOR 30 S. THERE WERE 182 PTS IN HPSD GROUP: 106 (58.2%) PAROXYSMAL AF, WHO UNDERWENT ABLATION WITH 45/50 W, CONTACT FORCE OF 8¿15G/10¿20G AND 35 ML/MIN FLOW RATE ON ANTERIOR AND POSTERIOR LEFT ATRIAL WALL, RESPECTIVELY. MEDIAN FOLLOW-UP WAS 32±16 MONTHS. SUCCESS WAS OBSERVED IN 94 (59.5%) PATIENTS IN LPLD AND 152 (83.5%) IN HPSD, IN LPLD GROUP WE DOCUMENTED A MEDIAN HRI OF 4.3 BPM (8%), COMPARED TO PREABLATION HEART RATE, WHILE A HIGHER HRI IN HPSD GROUP OF HRI 13.5 BPM (27.2%) WAS NOTED. HEART RATE INCREASE WAS ASSOCIATED WITH A HIGHER SUCCESS RATE IN BOTH ABLATION TECHNIQUES AND INDEPENDENTLY SHOWED AN IMPORTANT IMPACT ON THE SUCCESS RATE AFTER AF ABLATION. HPSD COMPARED TO LPLD SHOWED A HIGHER PROPORTION OF HRI AND ALSO DEMONSTRATED A SUPERIORITY IN MAINTAINING SINUS RHYTHM AT A LONG-TERM FOLLOW-UP. THE GOAL OF THE STUDY WAS TO DOCUMENT, ANALYZE, AND DEFINE IF HEART RATE INCREASE (HRI) DURING A FIRST ATRIAL FIBRILLATION (AF) ABLATION WITH HIGH-POWER SHORT-DURATION (HPSD) COMPARING TO LOW-POWER LONG-DURATION (LPLD) CAN IMPACT ON OUTCOME, INCLUDING RECURRENCE, IN A LONG-TERM FOLLOW-UP ANALYSIS. THREE COMPLICATIONS OF PSEUDOANEURYSM OCCURRED.

    Description of Event or Problem · 0

    FURTHER INFORMATION PROVIDED BY THE PHYSICIAN CONFIRMS THAT THE ADVERSE EVENT WAS NOT RELATED TO AN ABBOTT DEVICE, MAKING THIS EVENT NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535572 AGILIS NXT INTRODUCER, UNKNOWN INTRODUCER, CATHETER DYB ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown