BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS AORTIC 20 MM

    MDR report key: 17523741 · Received August 12, 2023

    Report

    Report Number
    MW5130688
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    September 9, 2013
    Manufacturer
    NUMED, INC.
    Product Code
    OZT
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC CORE VALVE THERE WAS MODERATE AORTIC REGURGITATION (AR). A BALLOON VALVULOPLASTY WAS PERFORMED UTILIZING A NON-MEDTRONIC BALLOON (NUMED CANADA INC. NUCLEUS AORTIC 20 MM REFERENCE NUMBER: PVN230 LOT: Y-3357), HOWEVER POST-VALVULOPLASTY A VENTRICULAR SEPTAL RUPTURE WAS DOCUMENTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PATIENT WAS INTUBATED AND A SECOND CORE VALVE WAS SUCCESSFULLY IMPLANTED WHICH RECTIFIED THE AR FROM MODERATE TO MILD. THE VENTRICULAR SEPTAL RUPTURE HAD SUBSEQUENTLY REDUCED IN SIZE WITH NO FURTHER SIGN OF BLEEDING. POST-PROCEDURE (SAME DAY) THE PATIENT DEVELOPED A LEFT BUNDLE BRANCH BLOCK (LBBB). ONE DAY POST-IMPLANT, COMPLETE HEART BLOCK (CHB) WAS NOTED WHEN THE PATIENT TEMPORARY PACING RATE WAS SLOWED. ALSO NOTED WAS OCCASIONAL RUNS OF NON-SUSTAINED VENTRICULAR TACHYCARDIA, THIS CAUSED SOME DIZZINESS AND PALPITATIONS WHICH WAS TREATED WITH MEDICATION. THE PATIENT HAD A PACEMAKER SUCCESSFULLY IMPLANTED SIX DAYS POST? IMPLANT DUE TO THE CHB. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. (B)(4) THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2219516 NUCLEUS AORTIC 20 MM BALLOON AORTIC VALVULOPLASTY OZT NUMED, INC. Y-3357

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown