BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 15848507 · Received November 22, 2022

    Report

    Report Number
    2135147-2022-02183
    Event Type
    Injury
    Date Received
    November 22, 2022
    Report Date
    January 20, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P120021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Additional Manufacturer Narrative · 0

    AN EVENT OF ATRIAL FIBRILLATION TWO TO THREE WEEKS AFTER IMPLANT OF A AMPLATZER PFO OCCLUDER WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR ADDITIONAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.NA.

    Description of Event or Problem · 0

    THE RESEARCH ARTICLE PRESENTS A CASE: DETECTION OF SECONDARY ATRIAL FIBRILLATION FOLLOWING PERCUTANEOUS FORAMEN OVALE CLOSURE FOR CRYPTOGENIC STROKE USING AN INSERTABLE CARDIAC MONITOR REPORTED A CASE OF A 61-YEAR-OLD MAN PRESENTED WITH TRANSIENT DYSARTHRIA AND LEFT UPPER EXTREMITY NUMBNESS. HEAD MRI SHOWED AN ACUTE INFARCT IN THE LEFT TEMPORAL LOBE AND MULTIPLE OLD INFARCTS IN THE BILATERAL CORTICES. A TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED A PATENT FORAMEN OVALE WITH A LARGE SHUNT. NO DEEP VEIN THROMBOSIS WAS FOUND. HE SUFFERED A RECURRENT CEREBRAL INFARCTION WHILE TAKING ANTIPLATELET THERAPY. AN INSERTABLE CARDIAC MONITOR WAS IMPLANTED ON THE 41ST DAY, AND THE ANTIPLATELET TREATMENT WAS CHANGED TO WARFARIN. THE INSERTABLE CARDIAC MONITOR DID NOT DETECT ATRIAL FIBRILLATION, EVEN WHEN THE PATIENT HAD A RECURRENT TRANSIENT ISCHEMIC ATTACK ON THE 57TH DAY UNDER WARFARIN THERAPY. THE PATIENT UNDERWENT PERCUTANEOUS FORAMEN OVALE CLOSURE (UNKNOWN SIZED AMPLATZER PFO OCCLUDER WAS IMPLANTED) ON THE 63RD DAY. ON POSTOPERATIVE DAYS 18¿25, AN INSERTABLE CARDIAC MONITOR DETECTED BRIEF ATRIAL FIBRILLATION, AND HE TOOK RIVAROXABAN FOR THREE MONTHS. ATRIAL FIBRILLATION MAY OCCUR SECONDARY TO PERCUTANEOUS PATENT FORAMEN OVALE CLOSURE FOR CRYPTOGENIC STROKE. THE INSERTABLE CARDIAC MONITOR MAY HELP DIAGNOSE THE PATHOGENESIS OF SECONDARY ATRIAL FIBRILLATION AND DETERMINE THE OPTIMAL ANTITHROMBOTIC THERAPY.[THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR OF THIS ARTICLE IS EGASHIRA, SHUHEI MD , 1-CHOME-4-1 UEDA MORIOKA, IWATE 020-0066 JAPAN]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362171 AMPLATZER PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention