BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG II

    MDR report key: 17872799 · Received October 4, 2023

    Report

    Report Number
    2135147-2023-04321
    Event Type
    Injury
    Date Received
    October 4, 2023
    Date of Event
    August 9, 2022
    Report Date
    October 4, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    KRD
    PMA / PMN Number
    K071699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT IS ESTIMATED. D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. D6 - THE IMPLANT DATE IS ESTIMATED. THE ADDITIONAL PATIENT EFFECT OF MALFUNCTION REPORTED IN THE ARTICLE IS CAPTURED UNDER A SEPARATE MEDWATCH REPORT. AS REPORTED THROUGH A ARTICLE REVIEW A 10 YEARS OLD PATIENT PRESENTED WITH HEART MURMUR AND A CORONARY ARTERY FISTULA (CAF) FROM THE LEFT MAIN CORONARY ARTERY TO THE RIGHT ATRIUM (RA). AN UNKNOWN AMPLATZER PLUG WAS IMPLANTED. AFTER 1 YEAR POST PROCEDURE, THERE WAS A RESIDUAL SHUNT VIA TWO ORIFICES TO THE RIGHT ATRIUM. THE PATIENT UNDERGOING INTERVENTION, BOTH PERCUTANEOUS AND SURGICAL TECHNIQUES WERE SAFE AND EFFECTIVE. THE ARTICLE CONCLUDED THE PREVALENCE OF CAFS WAS 0.2%, THE MAJORITY ORIGINATED FROM THE LEFT ANTERIOR DESCENDING ARTERY (LAD), AND THE PULMONARY ARTERY WAS THE MAIN DRAINAGE SITE. 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. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE ARTICLE, ¿CORONARY ARTERY FISTULAS: A 12-YEAR SINGLE-CENTER EXPERIENCE¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 10 YEAR OLD FEMALE PATIENT THAT PRESENTED WITH HEART MURMUR AND A CORONARY ARTERY FISTULA (CAF) FROM THE LEFT MAIN CORONARY ARTERY TO THE RIGHT ATRIUM (RA). IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN AMPLATZER VASCULAR PLUG II WAS IMPLANTED. IT WAS LATER REPORTED ONE YEAR POST-PROCEDURE, THERE WAS A RESIDUAL SHUNT VIA TWO ORIFICES TO THE RIGHT ATRIUM. A DECISION WAS MADE TO IMPLANT AN UNKNOWN AMPLATZER DUCTAL OCCLUDER. FOLLOW UP ANGIOGRAPHY NINE MONTHS LATER REVEALED COMPLETE CLOSURE OF THE CAF AFTER THE EMERGENCES OF THE CIRCUMFLEX ARTERY. THE ARTICLE CONCLUDED THE PREVALENCE OF CAFS WAS 0.2%, THE MAJORITY ORIGINATED FROM THE LEFT ANTERIOR DESCENDING ARTERY (LAD), AND THE PULMONARY ARTERY WAS THE MAIN DRAINAGE SITE. IN PATIENTS UNDERGOING INTERVENTION, BOTH PERCUTANEOUS AND SURGICAL TECHNIQUES WERE SAFE AND EFFECTIVE. [(B)(6)].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104814 AMPLATZER VASCULAR PLUG II DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female Required Intervention| H