BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 19042916 · Received April 4, 2024

    Report

    Report Number
    2135147-2024-01528
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    August 8, 2022
    Report Date
    May 24, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF AMPLATZER DUCT OCCLUDER WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH CO-MORBIDITIES THAT INCLUDED PATENT DUCTUS ARTERIOSUS AND PULMONARY HYPERTENSION. THE COMPLICATION REPORTED WAS OBSTRUCTION/OCCLUSION (PROTRUSION OF RETENTION SKIRT IN DESCENDING AORTA). A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. LITERATURE ATTACHMENT: ARTICLE TITLE " DOES A CHANGE IN DEVICE DESIGN ALTER DEVICE SIZE SELECTION? A COMPARISON OF CONVENTIONAL AND OCCLUTECH DUCT OCCLUDER DESIGNS"

    Additional Manufacturer Narrative · 0

    LITERATURE ARTICLE: "DOES A CHANGE IN DEVICE DESIGN ALTER DEVICE SIZE SELECTION? A COMPARISON OF CONVENTIONAL AND OCCLUTECH DUCT OCCLUDER DESIGNS. THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    THE ARTICLE, "DOES A CHANGE IN DEVICE DESIGN ALTER DEVICE SIZE SELECTION? A COMPARISON OF CONVENTIONAL AND OCCLUTECH DUCT OCCLUDER DESIGNS", WAS REVIEWED. THE ARTICLE PRESENTED A PROSPECTIVE, SINGLE CENTER STUDY TO EXAMINE THE FEASIBILITY AND SAFETY OF SUCH AN APPROACH, AND COMPARED OCCLUTECH DUCT OCCLUDER (ODO) AND CONVENTIONAL DUCT OCCLUDERS (CDO) DEVICES WITH RESPECT TO DEVICE SIZES DEPLOYED, TO ASCERTAIN IF THE NEWER DESIGN HAD ANY ADVANTAGES. DEVICES INCLUDED IN THIS STUDY WERE OCCLUTECH DUCT OCCLUDER, AMPLATZER DUCT OCCLUDER, LIFETECH DUCT OCCLUDER, AND VASCULAR INNOVATIONS COCOON. THE ARTICLE CONCLUDED THAT THE STUDY FOUND SUCCESSFUL CLOSURE OF RELATIVELY LARGER PDA IN INFANTS AND CHILDREN USING SMALLER ODO COMPARED WITH CDO, WITHOUT EMBOLISATION OR AORTIC NARROWING. IT ALSO DEMONSTRATED THAT A DIFFERENT DEVICE SIZE SELECTION TECHNIQUE MAY BE SAFELY EMPLOYED WITH THE ODO. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ANAND SUBRAMANIAN, DEPARTMENT OF PEDIATRIC CARDIOLOGY, SRI JAYADEVA INSTITUTE OF CARDIOVASCULAR SCIENCES & RESEARCH, BANNERGHATTA ROAD, BANGALORE, INDIA, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM DECEMBER 2017 TO DECEMBER 2020. A TOTAL OF 210 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 105 WERE IN THE CONTROL GROUP AND GIVEN A CDO DEVICE. THE NUMBER OF ABBOTT DEVICES COULD NOT BE CONFIRMED. THE AVERAGE AGE WAS 51.4 MONTHS, THE MEAN WEIGHT WAS 12.16KG, AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED PATENT DUCTUS ARTERIOSUS AND PULMONARY HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63227 AMPLATZER DUCT OCCLUDER OCCLUDER, PATENT DUCTUS, ARTERIOSUS MAE ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown