BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORONTO (RETIRED)

    MDR report key: 23206307 · Received October 2, 2025

    Report

    Report Number
    2135147-2025-05613
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    January 1, 2018
    Report Date
    October 2, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P970030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF TORONTO VALVE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, DYSLIPIDEMIA, DIABETES MELLITUS, PRIOR ENDOCARDITIS, SMOKING, CHRONIC LUNG DISEASE, DIALYSIS, PRIOR TRANSIENT ISCHEMIC ATTACK, STROKE, PERIPHERAL ARTERY DISEASE, CORONARY ARTERY BYPASS GRAFT, PRIOR MITRAL/TRICUSPID SURGERY, ATRIAL FIBRILLATION (PAROXYSMAL, PERSISTENT, PERMANENT), ATRIAL FLUTTER, PREOPERATIVE RBBB/LBBB, AND PRIOR PACEMAKER/IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. COMPLICATIONS REPORTED INCLUDED SURGICAL INTERVENTION (VALVE-IN-VALVE), UNEXPECTED MEDICAL INTERVENTION (POST-DILATATION, BLOOD TRANSFUSION), HOSPITALIZATION, STROKE, HEART BLOCK, AORTIC REGURGITATION; 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 INCIDENT 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 REVIEW: SNORKEL STENTING DURING TRANSCATHETER AORTIC VALVE IMPLANTATION: A SINGLE-CENTER STUDY.

    Description of Event or Problem · 0

    THE ARTICLE, "SNORKEL STENTING DURING TRANSCATHETER AORTIC VALVE IMPLANTATION: A SINGLE-CENTER STUDY", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND CLINICAL OUTCOMES OF SNORKEL STENTING IN PATIENTS AT HIGH RISK OF DEVELOPING CORONARY OBSTRUCTION (CO). DEVICES INCLUDED IN THE STUDY WERE TRIFECTA, MITROFLOW, FREESTYLE, COREVALVE, EVOLUT R, EVOLUT PRO, PERCEVAL, TORONTO, EVOLUT PRO+, EVOLUT FX, SAPIEN 3, AND SAPIEN ULTRA. THE ARTICLE CONCLUDED THAT SNORKEL STENTING SHOULD BE CONSIDERED FOR SELECTED HIGH- OR PROHIBITIVE-SURGICAL-RISK PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WHO ARE AT INCREASED RISK OF DEVELOPING CO. THIS TECHNIQUE SHOWED FAVORABLE PROCEDURAL OUTCOMES FOR PREVENTING CO OCCURRING DURING OR IN THE PERIOPERATIVE PERIOD OF TAVI PROCEDURES. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MASSIMO BAUDO, DEPARTMENT OF CARDIAC SURGERY RESEARCH, LANKENAU INSTITUTE FOR MEDICAL RESEARCH, MAIN LINE HEALTH, WYNNEWOOD, PA 19096, USA, WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2018 TO DECEMBER 2023. A TOTAL OF 21 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 8 (38.1%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 81.3 YEARS AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED HYPERTENSION, DYSLIPIDEMIA, DIABETES MELLITUS, PRIOR ENDOCARDITIS, SMOKING, CHRONIC LUNG DISEASE, DIALYSIS, PRIOR TRANSIENT ISCHEMIC ATTACK, STROKE, PERIPHERAL ARTERY DISEASE, CORONARY ARTERY BYPASS GRAFT, PRIOR MITRAL/TRICUSPID SURGERY, ATRIAL FIBRILLATION (PAROXYSMAL, PERSISTENT, PERMANENT), ATRIAL FLUTTER, PREOPERATIVE RBBB/LBBB, AND PRIOR PACEMAKER/IMPLANTABLE CARDIOVERTER DEFIBRILLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307243 TORONTO (RETIRED) HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL UNK TORONTO VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown