BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® DUCT OCCLUDER

    MDR report key: 12969313 · Received December 9, 2021

    Report

    Report Number
    2135147-2021-00548
    Event Type
    Injury
    Date Received
    December 9, 2021
    Report Date
    December 9, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MAE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN AN RESEARCH ARTICLE PERIVALVULAR LEAK/RESIDUAL LEAK, HEMOLYSIS, BLEEDING, BLOOD TRANSFUSION, RETROPERITONEAL HEMORRHAGE, DEVICE ADVANCEMENT DIFFICULTY, PERFORATIONS, TAMPONADE, DISSECTION OF THE LEFT ATRIUM, DISLODGED TO THE LEFT ATRIUM, CORONARY AIR EMBOLISM, BRADYCARDIA, VENTRICULAR TACHYARRHYTHMIA, LEAFLET ENTRAPMENT AND VALVE DISC MOTION INTERFERENCE WERE REPORTED. 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. PLEASE NOTE, PER INSTRUCTIONS FOR USE, ARTMT100092302 REV. A, "THE AMPLATZER¿ DUCT OCCLUDER IS A PERCUTANEOUS, TRANSCATHETER OCCLUSION DEVICE INTENDED FOR THE NONSURGICAL CLOSURE OF A PATENT DUCTUS ARTERIOSUS (PDA)."

    Description of Event or Problem · 0

    THE ARTICLE, "LONG-TERM OUTCOMES OF CATHETER-BASED INTERVENTION FOR CLINICALLY SIGNIFICANT PARAVALVULAR LEAK", WAS REVIEWED. THIS RESEARCH ARTICLE IS A PROSPECTIVE SINGLE CENTER EXPERIENCE TO ASSESS THE LONG-TERM OUTCOMES OF PATIENTS UNDERGOING PERCUTANEOUS PARAVALVULAR LEAK (PVL) CLOSURE. AMPLATZER¿ DUCT OCCLUDER (ADO), THE AMPLATZER¿ VASCULAR PLUG II (AVP II), THE AMPLATZER¿ VASCULAR PLUG III (AVP III) (ALL ABBOTT) THE OCCLUTECH® PLD OCCLUDER (OCCLUTECH GMBH, JENA, GERMANY) AND THE NIT-OCCLUD®COILS (PFM MEDICAL, COLOGNE, GERMANY) WERE ASSOCIATED WITH THE STUDY. THE ARTICLE CONCLUDED THAT FOR PATIENTS WHO ARE DEEMED INTERMEDIATE- TO HIGH-RISK FOR REPEAT SURGERY, TRANSCATHETER PVL CLOSURE SHOWS REASONABLE CLINICAL SUCCESS RATES, WITH A SIGNIFICANT IMPROVEMENT IN SYMPTOMS, AND A RELATIVELY LOW RATE OF PERIPROCEDURAL COMPLICATIONS. [THE PRIMARY AND CORRESPONDENCE AUTHOR OF THE ARTICLE IS LEOR PERL, MD, DEPARTMENT OF CARDIOLOGY, RABIN MEDICAL CENTER, BEILINSON HOSPITAL, 39 JABOTINSKY ST, PETACH TIKVA, 4941492, ISRAEL, WITH CORRESPONDING EMAIL: [email protected]]. RELATED MANUFACTURER REPORT NUMBER: 2135147-2021-00547, 2135147-2021-00549.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866224 AMPLATZER® DUCT OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MAE ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention