BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PICCOLO

    MDR report key: 13911532 · Received March 25, 2022

    Report

    Report Number
    2135147-2022-00102
    Event Type
    Injury
    Date Received
    March 25, 2022
    Date of Event
    March 1, 2022
    Report Date
    May 20, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MAE
    UDI-DI
    05415067031020
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF EMBOLISM OF A 4/6MM PICCOLO DEVICE WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MEASUREMENTS AS REPORTED FROM THE FIELD WAS PERFORMED. PER THE SIZING TABLE IN THE INSTRUCTIONS FOR USE, THE DUCT WAS LONGER THAN THE SIZING CHART INCLUDED FOR PATIENTS LARGER THAN 2KS, MEASURING AT 11MM, AND THAT THE DEVICE DIAMETER SELECTED (4MM) WAS LARGER THAN RECOMMENDED FOR A MINIMAL DUCTUS DIAMETER OF 1.9MM (3MM). THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. 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) 2022, A 4/6 AMPLATZER PICCOLO WAS SUCCESSFULLY IMPLANTED IN A (B)(6), (B)(6) PATIENT IN THE INTRADUCTAL POSITION. THE PATIENT HAD THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: PDA MINIMAL DIAMETER OF 1.9 MM, PDA LENGTH OF 10-12 MM AND DIAMETER AT AORTIC AMPULLA OF 5.3 MM. OVERNIGHT, THE DEVICE HAD BECAME EMBOLIZED AND TRAVELED INTO THE DISTAL LEFT PULMONARY ARTERY (LPA). IN AN EMERGENCY PROCEDURE ON (B)(6) 2022, THE DEVICE WAS REMOVED VIA TRANSCATHETER SNARE TO RESOLVE THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT AND IS CURRENTLY STABLE. THE PHYSICIAN ALLEGES THE CAUSE OF THE EVENT TO BE DUE TO THE DEVICE BEING UNDERSIZED. IT WAS UNKNOWN IF THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697298 AMPLATZER PICCOLO OCCLUDER, PATENT DUCTUS, ARTERIOSUS MAE ABBOTT MEDICAL OCCLUDER 7789872 05415067031020

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Unknown Life Threatening| R