BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PICCOLO

    MDR report key: 15902336 · Received December 2, 2022

    Report

    Report Number
    2135147-2022-02310
    Event Type
    Injury
    Date Received
    December 2, 2022
    Date of Event
    November 1, 2022
    Report Date
    January 26, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MAE
    UDI-DI
    05415067031037
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. IMPLANT DATE & EXPLANT DATE ARE UNKNOWN AS THIS IS A LITERATURE ARTICLE. DATE OF EVENT IS UNKNOWN AS THIS IS A LITERATURE ARTICLE.

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, A 5-4 AMPLATZER PICCOLO OCCLUDER DEVICE WAS DEPLOYED IN A 4 WEEK OLD PATIENT AT 30 WEEKS GESTATION. THE DEVICE WAS TOO LONG AND ENCROACHED ON THE AORTA AND LPA, AND THUS WAS REMOVED BEFORE RELEASE. A SECOND AMPLATZER PICCOLO OCCLUDER (5-2) DEVICE WAS ATTEMPTED. ON RELEASE, THE DEVICE EMBOLIZED TO THE RIGHT PULMONARY ARTERY. THE DEVICE WAS SUCCESSFULLY RETRIEVED USING A 10-MM GOOSE-NECK SNARE. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    THE ARTICLE, "SPONTANEOUS CLOSURE OF PATENT DUCTUS ARTERIOSUS IN PRETERM BABIES AFTER FAILED ATTEMPTS AT TRANSCATHETER DEVICE CLOSURE", WAS REVIEWED. THIS RESEARCH ARTICLE REPORTED A CASE STUDY ON A 4 WEEK OLD PATIENT AT 30 WEEKS GESTATION. WEIGHT AT THE TIME OF CARDIAC CATHETERIZATION WAS 1.86 KG. THE PATIENT WAS TRANSFERRED FROM AN OUTSIDE HOSPITAL FOR TRANSCATHETER DEVICE CLOSURE OF THE PATENT DUCTUS ARTERIOSUS (PDA) AFTER FAILURE OF IBUPROFEN THERAPY. ECHOCARDIOGRAPHY DEMONSTRATED A LARGE PDA (DIAMETER 3 MM) WITH A LEFT-TO-RIGHT SHUNTING, MODERATE LEFT HEART ENLARGEMENT, AND MILD MITRAL REGURGITATION. AN ANGIOGRAM DEMONSTRATED A TYPE C TUBULAR PDA WITH A MINIMUM DIAMETER OF 3.5 MM. FIRST, AN 5-4 AMPLATZER PICCOLO OCCLUDER DEVICE (5¿4 SIZE) WAS DEPLOYED. AS THE DEVICE WAS TOO LONG AND ENCROACHED ON THE AORTA AND LPA, THE DEVICE WAS REMOVED BEFORE RELEASE. A SECOND AMPLATZER PICCOLO OCCLUDER (5-2) DEVICE WAS ATTEMPTED. ON RELEASE, THE DEVICE EMBOLIZED TO THE RIGHT PULMONARY ARTERY. THE DEVICE WAS SUCCESSFULLY RETRIEVED USING A 10-MM GOOSE-NECK SNARE. THE NEXT MORNING, AN ECHOCARDIOGRAM SHOWED THAT THE PDA WAS SIGNIFICANTLY SMALLER. ON REPEAT ECHOCARDIOGRAM 3 DAYS LATER, PDA HAD CLOSED. PDA REMAINED CLOSED IN FOLLOW-UP ECHOCARDIOGRAM AFTER 10 WEEKS. [THE PRIMARY AND CORRESPONDING AUTHOR OF THE ARTICLE IS AHMED DENIWAR, MD, DIVISION OF PEDIATRIC CARDIOLOGY, MCGOVERN MEDICAL SCHOOL, UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON, TEXAS, USA, WITH CORRESPONDING EMAIL: [email protected].] RELATED EVENTS : CN-140987, CN-140984.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102692 AMPLATZER PICCOLO OCCLUDER, PATENT DUCTUS, ARTERIOSUS MAE ABBOTT MEDICAL Occluder 05415067031037
    2329253 AMPLATZER PICCOLO OCCLUDER, PATENT DUCTUS, ARTERIOSUS MAE ABBOTT MEDICAL Occluder 05415067031037

    Patients

    Seq Age Sex Outcome Treatment
    1 4 WK Female Required Intervention