BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG II

    MDR report key: 20044967 · Received August 23, 2024

    Report

    Report Number
    2135147-2024-04116
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    October 1, 2014
    Report Date
    August 22, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    KRD
    PMA / PMN Number
    K071699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF TRANSCATHETER CLOSURE MANAGEMENT OF MITRAL PARAVALVULAR LEAKAGE: A SINGLE CENTER EXPERIENCE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING PULMONARY ARTERIAL HYPERTENSION, TRICUSPID REGURGITATION, ATRIAL FIBRILLATION, PRIOR AORTIC VALVE REPLACEMENT, HYPERTENSION, TRICUSPID VALVULOPLASTY, CORONARY ARTERY DISEASE, AORTIC PARAVALVULAR LEAKAGE, AORTIC VALVE REGURGITATION. SOME OF THE COMPLICATIONS REPORTED WERE DEATH, UNEXPECTED MEDICAL INTERVENTION (BLOOD TRANSFUSION), HEMOLYSIS, BLEEDING, PLEURAL EFFUSION, OBSTRUCTION, OFF LABEL USE 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. B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLED "TRANSCATHETER CLOSURE MANAGEMENT OF MITRAL PARAVALVULAR LEAKAGE: A SINGLE CENTER EXPERIENCE".

    Description of Event or Problem · 0

    THE ARTICLE, "TRANSCATHETER CLOSURE MANAGEMENT OF MITRAL PARAVALVULAR LEAKAGE: A SINGLE CENTER EXPERIENCE", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY TO PRESENT OUR EXPERIENCE WITH TRANSCATHETER CLOSURE OF MITRAL PARAVALVULAR LEAKAGE (PVL) AFTER SURGICAL VALVE REPLACEMENT IN XIJING HOSPITAL. DEVICES INCLUDED IN THE STUDY WERE AMPLATZER VASCULAR PLUGS II (AGA MEDICAL CORP.), AMPLATZER OCCLUDERS (AGA MEDICAL CORP.), OCCLUDER (STARWAY MEDICAL TECHNOLOGY CO., LTD.), AND PDA (MICROPORT). THE ARTICLE CONCLUDED THAT TRANSCATHETER MITRAL PVL CLOSURE REQUIRES COMPLEX CATHETER TECHNIQUES. HOWEVER, THIS TECHNIQUE IS MINIMALLY INVASIVE AND HAS A SHORTER HOSPITAL STAY. INTERVENTIONAL MITRAL PVL CLOSURE IS A SAFE AND EFFICACIOUS TECHNIQUE FOR HIGH-RISK SURGICAL PATIENTS WITH SYMPTOMATIC PARAVALVULAR REGURGITATION. [THE PRIMARY AUTHOR WAS YUE LI, DEPARTMENT OF CARDIO-VASCULAR SURGERY, AIR FORCE MEDICAL CENTER OF PEOPLE'S LIBERATION ARMY, BEIJING, CHINA. THE CORRESPONDING AUTHOR WAS JIAN YANG, DEPARTMENT OF CARDIOVASCULAR SURGERY, XIJING HOSPITAL, AIR FORCE MEDICAL UNIVERSITY, XI'AN, CHINA, WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM OCTOBER 2014 TO DECEMBER 2022. A TOTAL OF 81 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 76 OUT OF 105 DEVICES (71.7%) WERE ABBOTT DEVICES. THE AVERAGE AGE WAS 63 YEARS AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED PULMONARY ARTERIAL HYPERTENSION, TRICUSPID REGURGITATION, ATRIAL FIBRILLATION, PRIOR AORTIC VALVE REPLACEMENT, HYPERTENSION, TRICUSPID VALVULOPLASTY, CORONARY ARTERY DISEASE, AORTIC PARAVALVULAR LEAKAGE, AORTIC VALVE REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072107 AMPLATZER VASCULAR PLUG II DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention