BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 11586855 · Received March 29, 2021

    Report

    Report Number
    2135147-2021-00113
    Event Type
    Injury
    Date Received
    March 29, 2021
    Date of Event
    February 12, 2021
    Report Date
    April 14, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P120021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION FOR: G3, G6, H2, H6, AND H10 AS REPORTED IN A RESEARCH ARTICLE, 85 PATIENTS UNDERWENT TRANSCATHETER PATENT FORAMEN OVALE, 37 OF THOSE PATIENTS WERE IMPLANTED WITH AN AMPLATZER PFO OCCLUDER; EVENTS OF PERICARDIAL EFFUSION, ATRIAL FIBRILLATION, LARGE GROIN HEMATOMA, RESIDUAL SHUNT, CEREBROVASCULAR ACCIDENT, STROKE AND TRANSIENT ISCHEMIC ATTACK. 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.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ARTICLE, "PATENT FORAMEN OVALE CLOSURE AMONG PATIENTS WITH HYPERCOAGULABLE STATES MAINTAINED ON ANTITHROMBOTIC THERAPY" WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE WHETHER PRIMARY PATENT FORAMEN OVALE(PFO) CLOSURE IS ASSOCIATED WITH LOWER INCIDENCE CRYPTOGENIC STROKES AMONG PATIENTS WITH CLINICALLY SIGNIFICANT HYPERCOAGULABLE STATES(HCS) OF VARIOUS TYPES AND WHO ARE MAINTAINED ON ANTITHROMBOTIC THERAPY. AMPLATZER PFO OCCLUDER(ABBOTT) AND OCCLUTECH FIGULLA(OCCLUTECH GMBH) WERE ASSOCIATED WITH THE STUDY. THERE IS NO ALLEGATION OF MALFUNCTION OF THE ABBOTT DEVICE. THE ARTICLE CONCLUDED THAT AMONG PATIENTS WITH HCSS MAINTAINED ON ANTICOAGULANT OR ANTIPLATELET THERAPIES, PFO CLOSURE WAS ASSOCIATED WITH A SIGNIFICANTLY LOWER RISK OF CEREBROVASCULAR ACCIDENT(CVA) OR TRANSIENT ISCHEMIC ATTACK(TIA). THE PRIMARY AND CORRESPONDENCE AUTHOR OF THE ARTICLE IS JONATHAN BUBER, HEART CENTER, CHAIM SHEBA MEDICAL CENTRE, TEL-HASHOMER, ISRAEL WITH THE CORRESPONDING EMAIL: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480829 AMPLATZER PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R