BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER OCCLUDER (UNKNOWN)

    MDR report key: 10298503 · Received July 20, 2020

    Report

    Report Number
    2135147-2020-00304
    Event Type
    Injury
    Date Received
    July 20, 2020
    Report Date
    July 21, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6, H10. AS REPORTED IN A RESEARCH ARTICLE OF 60 PATIENTS WITH AN ASYMPTOMATIC OR MINIMALLY SYMPTOMATIC VENTRICULAR SEPTAL DEFECT, (VSD) ONE PATIENT HAD THE DEVICE EMBOLIZE, ANOTHER HAD SEVERE COMPROMISE OF THE TRICUSPID VALVE DURING ESTABLISHMENT OF THE ARTERIOVENOUS LOOP, AND A THIRD PATIENT HAD SUPRAVENTRICULAR TACHYCARDIA. THE SPECIFIC DEVICE IMPLANTED IN THE PATIENTS WHO EXPERIENCED COMPLICATIONS WAS NOT REPORTED, HOWEVER, AMPLATZER DUCT OCCLUDERS 1 AND 2, AS WELL AS AMPLATZER VASCULAR PLUG 2 (AVP2), WERE USED OFF LABEL TO CLOSE THE VSD. 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 A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    THE ARTICLE "EXERCISE CAPACITY AND VENTRICULAR REMODELING AFTER TRANSCATHETER VENTRICULAR SEPTAL DEFECT CLOSURE IN ASYMPTOMATIC OR MINIMALLY SYMPTOMATIC ADOLESCENTS AND ADULTS" WAS REVIEWED. THIS ARTICLE WAS A PROSPECTIVE STUDY TO INVESTIGATE SERIAL CHANGES IN EXERCISE CAPACITY AND VENTRICULAR REMODELING IN ASYMPTOMATIC OR MINIMALLY SYMPTOMATIC ADOLESCENTS AND ADULTS WITH VENTRICULAR SEPTAL DEFECTS WHO RECEIVED EITHER DEVICE CLOSURE OR CONSERVATIVE TREATMENT. FROM MARCH 2015 TO AUGUST 2018, 60 ELIGIBLE PATIENTS BETWEEN 16 AND 60 YEARS OLD WERE ENROLLED. TRANSCATHETER OCCLUDERS FROM TWO MANUFACTURERS ARE ASSOCIATED WITH THIS STUDY INCLUDING AMPLATZER DUCT OCCLUDER I, AMPLATZER DUCT OCCLUDER II, AMPLATZER VASCULAR PLUG II (ABBOTT) AND HEARTR PERIMEMBRANOUS VSD OCCLUDER (LIFETECH SCIENTIFIC). THE AVERAGE AGE WAS 28.3, AND THERE WERE 31 FEMALES. THERE ARE NO ALLEGATIONS AGAINST THE ABBOTT DEVICES. THE PRIMARY AUTHOR IS CHUN-AN CHEN, MD, PHD. THE CORRESPONDING AUTHOR IS JOU-KOU WANG, MD, PHD, OF DEPARTMENT OF CARDIOLOGY, NATIONAL TAIWAN UNIVERSITY CHILDREN¿S HOSPITAL, TAIWAN. THE CORRESPONDING EMAIL IS: [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761904 AMPLATZER OCCLUDER (UNKNOWN) TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening| R