BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, MEDIUM CURL, 8.5F

    MDR report key: 18378282 · Received December 21, 2023

    Report

    Report Number
    3005334138-2023-00581
    Event Type
    Injury
    Date Received
    December 21, 2023
    Report Date
    January 14, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 PSEUDOANEURYSM COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURING REF: 3005334138-2023-00580. THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY IN AN ARTICLE TITLED "COMPARISON OF ADVANCED GENERATION CRYOBALLOON ABLATION AND ABLATION INDEX-GUIDED PULMONARY VEIN ISOLATION WITH NON-PULMONARY VEIN TRIGGER INDUCTION TEST AND ADDITIONAL ABLATION IN PAROXYSMAL ATRIAL FIBRILLATION" EGAMI, YASUYUKI. 66.7: 1571-1580. SPRINGER (OCT 2023) BACKGROUND: AN ABLATION INDEX (AI)-GUIDED PULMONARY VEIN ISOLATION (PVI) OR 2ND GENERATION CRYOBALLOON (CB)-PVI HAS BEEN SHOWN TO REDUCE THE ATRIAL FIBRILLATION (AF) BURDEN BY 99% DESPITE THE ABSENCE OF ABLATION OF NON-PULMONARY VEIN (PV) TRIGGERS IN PATIENTS WITH PAROXYSMAL AF. THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE EFFECTS OF PVI ALONE STRATEGY USING 2ND GENERATION CB COMPARED WITH AI-GUIDED PVI WITH AN ADDITIONAL INDUCTION TEST AND SUBSEQUENT AF TRIGGER ABLATION. METHODS AND RESULTS: WE INVESTIGATED 223 PATIENTS WITH SYMPTOMATIC PAROXYSMAL AF WHO UNDERWENT AN INITIAL PVI BETWEEN AUGUST 2018 AND AUGUST 2020. THE STUDY PATIENTS WERE DIVIDED INTO 2 GROUPS: CB-PVI WITHOUT AN INDUCTION TEST (CB-PVI ALONE GROUP, N = 82) AND AI-GUIDED PVI WITH AN INDUCTION TEST AND SUBSEQUENT ADDITIONAL ABLATION OF NON-PV TRIGGERS (AI-PVI PLUS GROUP, N = 141). IN THE AI-PVI PLUS GROUP, A TOTAL OF 62 NON-PV TRIGGERS WERE INDUCED IN 38 PATIENTS, AND NON-PV TRIGGERS IN 22 PATIENTS WERE COMPLETELY ABLATED. THE PROCEDURE TIME AND LEFT ATRIUM DWELL TIME WERE SIGNIFICANTLY SHORTER IN THE CB-PVI ALONE GROUP THAN AI-PVI PLUS GROUP. THERE WERE NO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF PROCEDURAL COMPLICATIONS BETWEEN THE 2 GROUPS (P = 0.650). THE AF FREE SURVIVAL RATE IN THE CB-PVI ALONE GROUP AND AI-PVI PLUS GROUP WAS 80% VS. 80% AT 24 MONTHS (P = 0.969). CONCLUSIONS: AN PVI ALONE STRATEGY USING ADVANCED GENERATION CB DID NOT DIFFER IN THE CLINICAL OUTCOMES COMPARED WITH AN AI-GUIDED PVI STRATEGY WITH AN INDUCTION TEST AND SUBSEQUENT ABLATION OF NON-PV TRIGGERS IN THE PATIENTS WITH PAROXYSMAL AF. THERE WERE TWO OCCURRENCES OF INGUINAL PSEUDOANEURYSMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052161 AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, MEDIUM CURL, 8.5F CATHETER, INTRODUCER DYB ST. JUDE MEDICAL G408319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER, SL0