BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER II

    MDR report key: 20427488 · Received October 11, 2024

    Report

    Report Number
    2135147-2024-05005
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    January 1, 2010
    Report Date
    October 24, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 LITERATURE ATTACHMENT: ARTICLE TITLE "OUTCOMES OF TRANSCATHETER CLOSURE FOR CORONARY ARTERY FISTULAS WITH OR WITHOUT ANEURYSM, A COMPARATIVE STUDY". INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF OUTCOMES OF TRANSCATHETER CLOSURE FOR CORONARY ARTERY FISTULAS WITH OR WITHOUT ANEURYSM WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING CORONARY ARTERY DISEASE, HYPERTENSION, HYPERLIPIDEMIA, DIABETES, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, PRIOR PERCUTANEOUS CORONARY INTERVENTION, PRIOR PATENT DUCTUS ARTERIOSUS CLOSURE, HEART MURMUR, CHEST PAIN, PALPITATION, DYSPNEA ON EXERTION, AND INFECTIVE ENDOCARDITIS. 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 NUMBERS WERE NOT PROVIDED LITERATURE ATTACHMENT: ARTICLE TITLE: OUTCOMES OF TRANSCATHETER CLOSURE FOR CORONARY ARTERY FISTULAS WITH OR WITHOUT ANEURYSM: A COMPARATIVE STUDY.

    Description of Event or Problem · 0

    THE ARTICLE, "OUTCOMES OF TRANSCATHETER CLOSURE FOR CORONARY ARTERY FISTULAS WITH OR WITHOUT ANEURYSM: A COMPARATIVE STUDY", WAS REVIEWED.THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY TO FURTHER CLARIFY WHETHER THE PRESENCE OF AN ANEURYSM INCREASES THE RISK ASSOCIATED WITH TRANSCATHETER CLOSURE OF CORONARY ARTERY FISTULAS (CAFS) BY COMPARING THE OUTCOMES OF TRANSCATHETER CLOSURE IN CAFS WITH AND WITHOUT ANEURYSM. DEVICES INCLUDED IN THE STUDY WERE AMPLATZER DUCT OCCLUDER II, UNKNOWN COILS, UNKNOWN PATENT DUCTUS ARTERIOSUS OCCLUDERS, AND UNKNOWN VENTRICAL SEPTAL DEFECT OCCLUDERS. THE ARTICLE CONCLUDED THAT A LARGER FISTULA DIAMETERS AND THE PRESENCE OF CORONARY-CAMERAL FISTULAS ARE INDEPENDENT RISK FACTORS FOR THE OCCURRENCE OF ANEURYSMS IN PATIENTS WITH CAFS. THE OUTCOMES OF TRANSCATHETER CLOSURE ARE COMPARABLE FOR CAFS PATIENTS WITH AND WITHOUT ANEURYSM, THOUGH POST-CLOSURE THROMBOSIS WITHIN THE FISTULA APPEARS TO BE MORE COMMON IN PATIENTS WITH ANEURYSM. [THE PRIMARY AND CORRESPONDING AUTHOR WAS XIANGBIN PAN, DEPARTMENT OF STRUCTURAL HEART DISEASE, NATIONAL CENTER FOR CARDIOVASCULAR DISEASE, CHINA & FUWAI HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES & PEKING UNION MEDICAL COLLEGE, NO.167 NORTH LISHI RD, XICHENG DISTRICT, BEIJING 100037, CHINA, WITH CORRESPONDING EMAIL: [email protected]]THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2010 TO DECEMBER 2023. A TOTAL OF 104 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 11 (10.58%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 44.82 YEARS AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED CORONARY ARTERY DISEASE, HYPERTENSION, HYPERLIPIDEMIA, DIABETES, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, PRIOR PERCUTANEOUS CORONARY INTERVENTION, PRIOR PATENT DUCTUS ARTERIOSUS CLOSURE, HEART MURMUR, CHEST PAIN, PALPITATION, DYSPNEA ON EXERTION, AND INFECTIVE ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294205 AMPLATZER DUCT OCCLUDER II OCCLUDER, PATENT DUCTUS, ARTERIOSUS MAE ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention