BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PICCOLO

    MDR report key: 24380342 · Received February 18, 2026

    Report

    Report Number
    2135147-2026-01004
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    January 28, 2026
    Report Date
    February 18, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, LATE AORTIC OBSTRUCTION POST PATENT DUCTUS ARTERIOSUS CLOSURE MANAGED WITH RENATA MINIMA STENT. 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 MIGRATION COULD NOT BE CONCLUSIVELY DETERMINED. IT IS POSSIBLE THAT PROCEDURAL CIRCUMSTANCES (INSUFFICIENT DEVICE SIZING) CONTRIBUTED TO THE EVENT, HOWEVER THIS CANNOT BE DETERMINED. THE REPORTED HEART FAILURE AND CORONARY OBSTRUCTION WAS LIKELY A CASCADING EFFECT FROM THE EVENT. AN UNEXPECTED MEDICAL INTERVENTION AND PROLONGED HOSPITALIZATION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT: LATE AORTIC OBSTRUCTION POST PATENT DUCTUS ARTERIOSUS CLOSURE MANAGED WITH RENATA MINIMA STENT. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE ARTICLE, "LATE AORTIC OBSTRUCTION POST PATENT DUCTUS ARTERIOSUS CLOSURE MANAGED WITH RENATA MINIMA STENT", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 4-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF A LARGE PATENT DUCTUS ARTERIOSUS (PDA). THE PDA WAS MEASURED 2.6MM ON THE PULONARY END, 2.8MM ON THE AORTIC END, AND 5.3MM IN LENGTH. A 4MM X 2MM AMPLATZER PICCOLO WAS SELECTED FOR IMPLANT ON AN UNKNOWN DATE. THE DEVICE WAS IMPLANTED. ONE WEEK POST-PROCEDURE ECHOCARDIOGRAM REVEALED TRIVIAL DEVICE INTERFERENCE WITHIN THE DESCENDING AORTA. A REPEAT ECHOCARDIOGRAM ONE MONTH LATER SHOWED THE DEVICE EXTENDING INTO THE DESCENDING AORTA, CAUSING SEVERE COARCTATION, SEVERE LEFT VENTRICULAR DYSFUNCTION WITH AN EJECTION FRACTION OF 48%. THE FOLLOWING DAY THE PATIENT RENATA MINIMA 6MM X 16MM STENT WAS IMPLANTED. [THE PRIMARY AND CORRESPONDING AUTHOR WAS CHRISTOPHER HERRON, DEPARTMENT OF PEDIATRIC CARDIOLOGY, ORLANDO HEALTH ARNOLD PALMER HOSPITAL FOR CHILDREN, 92 W MILLER ST, ORLANDO, FL 34786, USA, WITH CORRESPONDING E-MAIL: [email protected].].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437016 AMPLATZER PICCOLO OCCLUDER, PATENT DUCTUS, ARTERIOSUS MAE ABBOTT MEDICAL 9-PDAP-04-02-L

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Female Required Intervention| H