BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PICCOLO

    MDR report key: 19651657 · Received July 1, 2024

    Report

    Report Number
    2135147-2024-03182
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 20, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF MIGRATION OR EXPULSION OF DEVICE (DEVICE EMBOLIZATION) WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. INFORMATION FROM THE FIELD INDICATED THAT WHEN THE DEVICE WAS RELEASED FROM THE CABLE, IT IMMEDIATELY EMBOLIZED TO AORTA. AN ARTERIAL CUTDOWN WAS PERFORMED BY CARDIOVASCULAR OPERATING ROOM (CVOR) TEAM AND VESSEL WAS ACCESSED WITH SNARE FOR DEVICE RETRIEVAL PROCEDURE. THE DEVICE WAS SUCCESSFULLY REMOVED. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED DEVICE EMBOLIZATION COULD NOT BE CONCLUSIVELY DETERMINED. THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 4 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (TVLP). THE DIMENSIONS OF THE PDA WERE MINIMAL DIAMETER 2.3MM, DIAMETER AT AORTIC AMPULLA WAS 3MM AND LENGTH WAS 9MM. THE SIZING OF THE DEVICE AND MEASUREMENTS WERE DONE USING CONTRAST INJECTION METHOD UNDER FLUOROSCOPY DURING THE CASE. DURING PROCEDURE, WHEN THE DEVICE WAS RELEASED FROM THE CABLE, IT IMMEDIATELY EMBOLIZED TO AORTA. AN ARTERIAL CUTDOWN WAS PERFORMED BY CARDIOVASCULAR OPERATING ROOM (CVOR) TEAM AND VESSEL WAS ACCESSED WITH SNARE FOR DEVICE RETRIEVAL PROCEDURE. THE DEVICE WAS SUCCESSFULLY REMOVED. THE PATIENT WAS REPORTED STABLE IN NEONATAL INTENSIVE CARE UNIT (NICU) AND THE PROCEDURE WAS POSTPONED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 4 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING PROCEDURE, WHEN THE DEVICE WAS RELEASED FROM THE CABLE, IT IMMEDIATELY EMBOLIZED TO AORTA. AN ARTERIAL CUTDOWN WAS PERFORMED BY CARDIOVASCULAR OPERATING ROOM (CVOR) TEAM AND VESSEL WAS ACCESSED WITH SNARE FOR DEVICE RETRIEVAL PROCEDURE. THE DEVICE WAS SUCCESSFULLY REMOVED. THE PATIENT WAS REPORTED STABLE IN NEONATAL INTENSIVE CARE UNIT (NICU) AND THE PROCEDURE WAS POSTPONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565689 AMPLATZER PICCOLO OCCLUDER, PATENT DUCTUS, ARTERIOSUS MAE ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male Required Intervention| L