BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES

    MDR report key: 22107807 · Received May 29, 2025

    Report

    Report Number
    3008452825-2025-00228
    Event Type
    Injury
    Date Received
    May 29, 2025
    Report Date
    May 29, 2025
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. PER THE IFU, CARDIAC TAMPONADE AND PERICARDIAL EFFUSION ARE KNOWN RISKS DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED ON BEHALF OF THE EUROPEAN SOCIETY OF CARDIOLOGY IN EUROPEAN HEART JOURNAL ¿ CARDIOVASCULAR IMAGING (2015) 16, 1198¿1206 "CARDIAC CT ANGIOGRAPHY FOR DEVICE SURVEILLANCE AFTER ENDOVASCULAR LEFT ATRIAL APPENDAGE CLOSURE"; SAW, JACQUELINE. WE REPORT OUR CONSECUTIVE SERIES OF NON-VALVULAR ATRIAL FIBRILLATION PATIENTS WHO UNDERWENT CCTA POST-LAA CLOSURE WITH AMPLATZER CARDIAC PLUG (ACP), AMULET (SECOND GENERATION ACP), OR WATCHMAN DEVICES. PATIENTS UNDERWENT CCTA TYPICALLY 1¿6 MONTHS POST-IMPLANTATION. PROSPECTIVE CARDIAC-GATED CCTA WAS PERFORMED WITH TOSHIBA 320-DETECTOR OR SIEMENS 2ND GENERATION 128-SLICE DUAL-SOURCE SCANNERS, AND IMAGES INTERPRETED WITH VITREA WORKSTATION TM. GFR, 30 ML/MIN/1.73 M2 WAS AN EXCLUSION. WE ASSESSED FOR DEVICE THROMBUS, RESIDUAL LAA LEAK, DEVICE EMBOLIZATION, POSITION, PERICARDIAL EFFUSION, OPTIMAL IMPLANTATION, AND DEVICE LOBE DIMENSIONS. FORTY-FIVE PATIENTS UNDERWENT CCTA AT MEDIAN 97 DAYS POST-LAA CLOSURE (18 ACP, 9 AMULET, 18 WATCHMAN). AVERAGE AGE WAS 75.5 YEARS, MEAN CHADS2 SCORE 3.1, AND CHADS-VASC SCORE 4.9. ALL HAD CONTRAINDICATIONS TO ORAL ANTICOAGULATION. POST-PROCEDURE, 41 WERE DISCHARGED ON DAPT. THERE WAS ONE DEVICE EMBOLIZATION (ACP, SUCCESSFULLY RETRIEVED PERCUTANEOUSLY) AND ONE THROMBUS (WATCHMAN, RESOLVED WITH 3 MONTHS OF WARFARIN). THERE WERE TWO PERICARDIAL EFFUSIONS, BOTH PRE-EXISTING AND NOT REQUIRING INTERVENTION. RESIDUAL LEAK (PATENCY) WAS SEEN IN 28/44, AND THE MECHANISMS OF LEAK WERE READILY IDENTIFIED BY CCTA (OFF-AXIS DEVICE, GAPS AT ORIFICE, OR FABRIC LEAK). MEAN FOLLOW-UP WAS 1.2 YEAR, WITH NO DEATH, STROKE, OR SYSTEMIC EMBOLISM. ONE CLINICALLY INSIGNIFICANT TRANSSEPTAL PUNCTURE-RELATED PERICARDIAL EFFUSION WHICH DID NOT REQUIRE INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993381 TRANSSEPTAL NEEDLE, BRK SERIES Trocar DRC ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening