BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA¿

    MDR report key: 20695129 · Received November 15, 2024

    Report

    Report Number
    2135147-2024-05779
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    January 1, 2015
    Report Date
    January 2, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B3: DATE OF EVENT WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: A CORONARY-FRIENDLY DEVICE MITIGATING RISK OF CORONARY OBSTRUCTION IN TRANSCATHETER AORTIC VALVE REPLACEMENT

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF SJM TRIFECTA VALVE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, DIABETES MELLITUS, STROKE, CHRONIC LUNG DISEASE, DIALYSIS, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, PRIOR CARDIAC SURGERY, PORCELAIN AORTA, PULMONARY EDEMA, AORTIC VALVE ETIOLOGY (DEGENERATIVE, RHEUMATIC). COMPLICATIONS REPORTED INCLUDED SURGICAL INTERVENTION (VIV), HOSPITALIZATION, AORTIC STENOSIS, DEVICE STENOSIS, FIBROUS CALCIFIC SVD; 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. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENTS COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. 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 TITLE: A CORONARY-FRIENDLY DEVICE MITIGATING RISK OF CORONARY OBSTRUCTION IN TRANSCATHETER AORTIC VALVE REPLACEMENT A CORONARY-FRIENDLY DEVICE MITIGATING RISK OF CORONARY OBSTRUCTION IN TRANSCATHETER AORTIC VALVE REPLACEMENT.

    Description of Event or Problem · 0

    THE ARTICLE, "A CORONARY-FRIENDLY DEVICE MITIGATING RISK OF CORONARY OBSTRUCTION IN TRANSCATHETER AORTIC VALVE REPLACEMENT", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY TO EVALUATE THE EARLY SAFETY AND EFFICACY OF STAND-ALONE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) USING THE J-VALVE (JIANSHI JIECHENG MEDICAL TECHNOLOGY CO. LTD) IN PATIENTS AT POTENTIAL HIGH RISK FOR CORONARY ARTERY OBSTRUCTION (CAO). DEVICES INCLUDED IN THE STUDY WERE TRIFECTA, FREEDOM SOLO, AND J-VALVE. THE ARTICLE CONCLUDED THAT STAND-ALONE TAVR USING THE J-VALVE MAY MITIGATE THE RISK OF TAVR-INDUCED CAO. [THE PRIMARY AND CORRESPONDING AUTHOR WAS LAI WEI, DEPARTMENT OF CARDIOVASCULAR SURGERY, ZHONGSHAN HOSPITAL, FUDAN UNIVERSITY, SHANGHAI, 200032, PEOPLE¿S REPUBLIC OF CHINA, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2015 TO JULY 2021. A TOTAL OF 20 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH ONLY ONE RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 72 YEARS AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED HYPERTENSION, DIABETES MELLITUS, STROKE, CHRONIC LUNG DISEASE, DIALYSIS, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, PRIOR CARDIAC SURGERY, PORCELAIN AORTA, PULMONARY EDEMA, AORTIC VALVE ETIOLOGY (DEGENERATIVE, RHEUMATIC).

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73461 TRIFECTA¿ HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R