BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES

    MDR report key: 9783115 · Received March 3, 2020

    Report

    Report Number
    2135147-2020-00092
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    December 1, 2016
    Report Date
    December 20, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION FOR D2ADDITIONAL INFORMATION FOR G4, G7, H2, H10.

    Additional Manufacturer Narrative · 0

    CORRECTION TO B5, D1, D4, G4, G7, H2, AND H10. AS REPORTED IN A RESEARCH ARTICLE, LEFT PULMONARY ARTERY OBSTRUCTION WERE NOTED DURING FOLLOW UP AFTER DEVICE IMPLANTATION. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE REMAINS IMPLANTED WAS NOT RETURNED FOR ANALYSIS. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. PLEASE NOTE, PER THE INSTRUCTIONS FOR USE, 600419-004 VERSION A, " THE AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES IS CONTRAINDICATED FOR PATIENTS WHO WEIGH LESS THAN 6 KG AND ARE YOUNGER THAN 6 MONTHS IN AGE". AN INITIAL REVIEW OF COMPLAINTS DATA WAS REVIEWED ON 14 APRIL 2020 AS A COMPONENT OF THE COMPLAINT HANDLING RISK REVIEW PER WI 90591806. THE MEDICAL DEVICE PROBLEM AND AHO CODES ARE CONSISTENT WITH THE HAZARDS/HARMS IDENTIFIED FOR THIS PRODUCT FAMILY, AND NO NEW HAZARDS OR HARMS WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AMPLATZER ADO II THAT MAY BE RELATED TO A SEVERE LEFT PULMONARY ARTERY OBSTRUCTION. DETAILS ARE LISTED IN THE ARTICLE, TITLED "DEVICE DEFORMATION AND LEFT PULMONARY ARTERY OBSTRUCTION AFTER TRANSCATHETER PATENT DUCTUS ARTERIOSUS CLOSURE IN PRETERM INFANTS". IT WAS REPORTED IN THE ARTICLE THAT IN (B)(6) 2016, 14 PATIENTS UNDERWENT TRANSCATHETER PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE. AN 30 DAYS OLD PATIENT THAT WEIGHT 1136 GRAMS WITH PDA DIAMETER OF 1.89MM AND PDA LENGTH OF 7.89MM WAS IMPLANTED WITH A 4-4 AMPLATZER ADO II. DURING FOLLOW UP, SEVERE LEFT PULMONARY ARTERY OBSTRUCTION WAS OBSERVED. THE PATIENT WAS ASYMPTOMATIC AND NO INTERVENTION WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    AS REPORTED IN A RESEARCH ARTICLE, LEFT PULMONARY ARTERY OBSTRUCTION WERE NOTED DURING FOLLOW UP AFTER IMPLANTATION WITH A 4-4 AMPLATZER PICCOLO. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE REMAINS IMPLANTED 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, ARTEN600042307 VERSION A, THE CORRECT SIZE PICCOLO OCCLUDER FOR THE MEASUREMENTS PROVIDED WAS 04-02, SMALLER THAN THE IMPLANTED DEVICE. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THE IMPLANTATION OF A LARGER THAN RECOMMENDED DEVICE COULD HAVE CONTRIBUTED.

    Description of Event or Problem · 1

    REFERENCE MANUFACTURING REPORT NUMBER: 2135147-2020-00090, 2135147-2020-00091, 2135147-2020-00093, 2135147-2020-00094. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AMPLATZER PICCOLO THAT MAY BE RELATED TO A SEVERE LEFT PULMONARY ARTERY OBSTRUCTION. DETAILS ARE LISTED IN THE ARTICLE, TITLED "DEVICE DEFORMATION AND LEFT PULMONARY ARTERY OBSTRUCTION AFTER TRANSCATHETER PATENT DUCTUS ARTERIOSUS CLOSURE IN PRETERM INFANTS." IT WAS REPORTED IN THE ARTICLE THAT IN (B)(6) 2016, 14 PATIENTS UNDERWENT TRANSCATHETER PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE. AN (B)(6) DAYS OLD PATIENT THAT WEIGHT (B)(6) GRAMS WITH PDA DIAMETER OF 1.89MM AND PDA LENGTH OF 7.89MM WAS IMPLANTED WITH A 4-4 AMPLATZER PICCOLO. DURING FOLLOW UP, SEVERE LEFT PULMONARY ARTERY OBSTRUCTION WAS OBSERVED. THE PATIENT WAS ASYMPTOMATIC AND NO INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242592 AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES OCCLUDER, PATENT DUCTUS, ARTERIOSUS MAE AGA MEDICAL CORPORATION 9-PDA2AS-04-04-L

    Patients

    Seq Age Sex Outcome Treatment
    1 30 DA Other