BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG

    MDR report key: 18753926 · Received February 21, 2024

    Report

    Report Number
    2135147-2024-00802
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    January 1, 2009
    Report Date
    February 21, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    KRD
    PMA / PMN Number
    K031810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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. THE ADDITIONAL PATIENT EFFECT OF MALFUNCTION REPORTED IN THE ARTICLE IS CAPTURED UNDER A SEPARATE MEDWATCH REPORT. SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF TREATMENT OF CORONARY ARTERY FISTULAS (CAFS) USING INTERVENTIONAL APPROACHES WERE REPORTED IN A RESEARCH ARTICLE "LONG-TERM OUTCOME OF INTERVENTIONAL APPROACHES FOR TREATMENT OF CORONARY ARTERY FISTULAS: A RETROSPECTIVE COHORT STUDY IN A GREAT REFERRAL CENTER", IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING PATENT FORAMEN OVALE, SINGLE CORONARY OSTIUM, TETRALOGY OF FALLOT TOTAL CORRECTION, SMALL ATRIAL SEPTAL DEFECT, AND CORONARY ARTERY FISTULAS. SOME OF THE COMPLICATIONS REPORTED WERE SURGICAL INTERVENTION, RESIDUAL SHUNT; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. 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.

    Description of Event or Problem · 0

    THE ARTICLE, "LONG-TERM OUTCOME OF INTERVENTIONAL APPROACHES FOR TREATMENT OF CORONARY ARTERY FISTULAS: A RETROSPECTIVE COHORT STUDY IN A GREAT REFERRAL CENTER", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY TO ASSESS THE OUTCOME OF TREATMENT OF CORONARY ARTERY FISTULAS (CAFS) USING INTERVENTIONAL APPROACHES. DEVICES INCLUDED IN THIS STUDY WERE COOK COILS, PFM COILS, EV3 COILS, ABBOTT AMPLATZER DUCT OCCLUDER II, AND AMPLATZER VASCULAR PLUG. THE ARTICLE CONCLUDED TRANS-CATHETER APPROACH FOR TREATING CAFS LEADS TO APPROPRIATE LONG-TERM OUTCOME WITH MINIMAL POTENTIAL SIDE EFFECTS. [THE PRIMARY AUTHOR WAS AVISA TABIB, HEART VALVE DISEASE RESEARCH CENTER, RAJAIE CARDIOVASCULAR MEDICAL AND RESEARCH CENTER, IRAN UNIVERSITY OF MEDICAL SCIENCES, TEHRAN, IRAN. THE CORRESPONDING AUTHOR WAS SEPIDEH MOHAMMADHOSEINI, RAJAIE CARDIOVASCULAR MEDICAL AND RESEARCH CENTER, IRAN UNIVERSITY OF MEDICAL SCIENCES, TEHRAN, IRAN, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM 2009 TO 2019. A TOTAL OF 29 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 20.7% RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 44 MONTHS, THE AVERAGE WEIGHT WAS 16.4 KG, AND THE AVERAGE GENDER WAS MALE. COMORBIDITIES INCLUDED PATENT FORAMEN OVALE, SINGLE CORONARY OSTIUM, TETRALOGY OF FALLOT TOTAL CORRECTION, SMALL ATRIAL SEPTAL DEFECT, AND CORONARY ARTERY FISTULAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483795 AMPLATZER VASCULAR PLUG DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention