BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTICO TRANSCATHETER AORTIC VALVE

    MDR report key: 17139759 · Received June 15, 2023

    Report

    Report Number
    2135147-2023-02608
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    June 22, 2022
    Report Date
    June 15, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE ATTACHMENT: TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS AT HIGH RISK OF CORONARY OBSTRUCTION. SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF PORTICO VALVE IMPLANT WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING SEVERE AORTIC STENOSIS, HYPERTENSION, DIABETES MELLITUS, PRIOR MYOCARDIAL INFARCTION, PRIOR PERCUTANEOUS CORONARY INTERVENTION, PRIOR CORONARY ARTERY BYPASS GRAFTING, PRIOR STROKE, CHRONIC KIDNEY DISEASE, ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, AND PERIPHERAL ARTERIAL DISEASE. SOME OF THE COMPLICATIONS REPORTED WERE ONE PATIENT DEATH RELATED TO STENT THROMBOSIS, VALVE-IN-VALVE PROCEDURES, CORONARY OCCLUSION, STENT THROMBOSIS, SURGICAL INTERVENTION, MYOCARDIAL INFARCTION AND STROKE; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE. 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, "TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS AT HIGH RISK OF CORONARY OBSTRUCTION" , WAS REVIEWED. THIS ARTICLE IS A RETROSPECTIVE MULTICENTER STUDY EXPERIENCE WITH TRANSCATHETER AORTIC VALVE REPLACEMENT TO EVALUATE THE SAFETY AND EFFICACY OF CORONARY PROTECTION BY PREVENTIVE CORONARY WIRING AND POSSIBLE EVENTUAL STENTING ACROSS THE CORONARY OSTIA. THE DEVICES ASSOCIATED WITH THIS STUDY INCLUDED SAPIEN XT, SAPIEN 3, COREVALVE, PORTICO, EVOLUT, SORIN MITROFLOW, SORIN FREEDOM SOLO, CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE, ST. JUDE MEDICAL TRIFECTA, ST. JUDE MEDICAL TORONTO (ST JUDE MEDICAL), SORIN SOPRANO (SORIN GROUP), SORIN PERICARBON. THE ARTICLE CONCLUDED THAT IN PATIENTS UNDERGOING TAVR WITH CORONARY PROTECTION, THOSE TREATED WITH SE VALVES HAD INCREASED RATES OF CLINICAL AND ANATOMIC FEATURES THAT INCREASE THE RISK OF CORONARY OBSTRUCTION. THESE INCLUDE AN INCREASED FREQUENCY OF VALVE-IN-VALVE PROCEDURES, SMALLER SINUSES OF VALSALVA, AND SMALLER VALVE-TO-CORONARY DISTANCES. THESE PATIENTS WERE OBSERVED TO HAVE INCREASED CARDIAC MORTALITY COMPARED WITH PATIENTS TREATED WITH BE VALVES, BUT THIS IS LIKELY DUE TO THEIR HIGHER RISK CLINICAL AND ANATOMIC PHENOTYPES RATHER THAN AS A FUNCTION OF THE VALVE TYPE ITSELF. [THE PRIMARY AND CORRESPONDING AUTHOR OF THIS STUDY IS YOUSIF AHMAD, YALE SCHOOL OF MEDICINE, YALE UNIVERSITY, NEW HAVEN, CONNECTICUT, WITH EMAIL: [email protected]]. THE TIME FRAME OF THIS STUDY WAS UNKNOWN. THE NUMBER OF PORTICO VALVES INVOLVED IN THE STUDY IS UNKNOWN. A TOTAL OF 236 PATIENTS WERE INCLUDED IN THIS STUDY, 135 PATIENTS (57.2%) WERE TREATED WITH BE VALVES, AND 101 (42.8%) WERE TREATED WITH SE VALVES. THE AVERAGE GENDER WAS FEMALE (161 OUT OF 236) AND THE AVERAGE AGE WAS 80.3±9.4 YEARS (BE VALVES) AND 80.2±7.6 YEARS (SE VALVES). COMORBIDITIES INCLUDED SEVERE AORTIC STENOSIS, HYPERTENSION, DIABETES MELLITUS, PRIOR MYOCARDIAL INFARCTION, PRIOR PERCUTANEOUS CORONARY INTERVENTION (PCI), PRIOR CORONARY ARTERY BYPASS GRAFTING (CABG), PRIOR STROKE, CHRONIC KIDNEY DISEASE, ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, AND PERIPHERAL ARTERIAL DISEASE. PORTICO COMPLAINT : (B)(4). POST-COMPLICATIONS: 1 PORTICO DEATH RELATED TO STENT THROMBOSIS, VALVE-IN-VALVE (VIV), CORONARY OCCLUSION, STENT THROMBOSIS, SURGICAL INTERVENTION, MYOCARDIAL INFARCTION, STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2093529 PORTICO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| L| S| R