BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 19015361 · Received April 1, 2024

    Report

    Report Number
    2135147-2024-01460
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    January 1, 2014
    Report Date
    April 23, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. LITERATURE ATTACHMENT: ARTICLE TITLE" PATENT FORAMEN OVALE CLOSURE VERSUS DRUG THERAPY IN PATIENTS OVER 60 YEARS AND A FOLLOW-UP OF 5 YEARS."

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF PATENT FORAMEN OVALE CLOSURE VERSUS DRUG THERAPY IN PATIENTS OVER 60 YEARS AND A FOLLOW-UP OF 5 YEARS WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING ARTERIAL HYPERTENSION, CONGESTIVE HEART FAILURE, CORONARY ARTERY DISEASE, DIABETES MELLITUS, HYPERCHOLESTEROLEMIA, SMOKING, ATRIAL SEPTAL ANEURYSM]. SOME OF THE COMPLICATIONS REPORTED WERE ATRIAL FIBRILLATION, ISCHEMIC STROKE, TRANSIENT ISCHEMIC ATTACK, RESIDUAL/PERSISTENT SHUNT THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. 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: PATENT FORAMEN OVALE CLOSURE VERSUS DRUG THERAPY IN PATIENTS OVER 60 YEARS AND A FOLLOW-UP OF 5 YEARS.

    Description of Event or Problem · 0

    THE ARTICLE, "PATENT FORAMEN OVALE CLOSURE VERSUS DRUG THERAPY IN PATIENTS OVER 60 YEARS AND A FOLLOW-UP OF 5 YEARS", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, MULTI-CENTER STUDY TO COMPARE RECURRENCE OF STROKE IN PATIENTS OVER 60 YEARS OLD WITH PATENT FORAMEN OVALE (PFO) CLOSURE VERSUS DRUG THERAPY ALONE. DEVICES INCLUDED IN THIS STUDY WERE UNKNOWN AMPLATZER OCCLUDER, CARDIA ULTRASEPT PFO, AND OCCLUTEC. THE ARTICLE CONCLUDED THAT THAT STRICT EXCLUSION OF PATIENTS OVER 60 YEARS FROM PFO CLOSURE SHOULD BE RECONSIDERED. AS LIFE EXPECTANCIES ARE INCREASING, PATIENTS SHOULD BE CONSIDERED FOR SAME TREATMENT AS YOUNGER PATIENTS, SINCE THE OUTCOMES ARE IMPROVED COMPARED TO PATIENTS TREATED WITH MEDICAL THERAPY ALONE. [THE PRIMARY AUTHOR WAS ANGELIKA EICHELMANN, DEPARTMENT OF PEDIATRICS, BETHLEHEM HOSPITAL STOLBERG, STOLBERG, GERMANY. THE CORRESPONDING AUTHOR WAS ALI ALJALLOUD, DEPARTMENT OF CARDIOLOGY, NEPHROLOGY AND INTERNAL INTENSIVE CARE, RHEIN-MAAS HOSPITAL MAUERFELDCHEN 25, 52146 WÜRSELEN, GERMANY, WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM 2014 TO 2020. A TOTAL OF 143 PATIENTS INCLUDED IN THIS STUDY UNDERWENT PFO CLOSURE, OF WHICH 19 (13.3%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 67 YEARS AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED ARTERIAL HYPERTENSION, CONGESTIVE HEART FAILURE, CORONARY ARTERY DISEASE, DIABETES MELLITUS, HYPERCHOLESTEROLEMIA, SMOKING, ATRIAL SEPTAL ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517505 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| S