BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 12273115 · Received August 4, 2021

    Report

    Report Number
    1718850-2021-01136
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    August 3, 2021
    Report Date
    July 5, 2021
    Manufacturer
    CORCYM CANADA CORP.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENT REPORT WAS INITIALLY SUBMITTED ON 3 AUGUST 2021, AND NOW RESUBMITTED AFTER MODIFICATION OF THE IMPORTER NUMBER. CORE ID: (B)(4). ENVIRONMENT: ACK3: THIS SUBMISSION HAS BEEN SENT TO THE PRODUCTION SYSTEM AND HAS BEEN PROCESSED BY THE FDA. PLEASE REFER TO THE SUMMARY SECTION BELOW TO DETERMINE IF THIS SUBMISSION HAS PASSED OR FAILED. BATCH ID: -20210803210033. DATE ENTERED: TUE AUG 03 15:03:30 EDT 2021. SUMMARY: PASSED:0, FAILED:1. SUBMISSION TYPE: FORM 3500A - ICSR R2. REPORT ID: 171885-2021-01136. SUBMISSION FAILURE DETAILS: ERROR MESSAGE: UF NUMBER HAS INCORRECT FORMAT. [0-9A-Z]{7,10}\-[0-9]{4}\-[0-9]{4,6} MESSAGE VALUE: 171885-2021-01136.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED ABOUT THIS EVENT THROUGH THE PAPER ''THE MATRYOSHKA PROCEDURE'' BY TOMAI ET AL. BASED ON THE INFORMATION REPORTED IN THE PAPER, IN 2015, A PERIMOUNT 21 MM BIOPROSTHESIS AND A VALSALVA 28 MM DACRON GRAFT WERE IMPLANTED IN THE AORTA ALONG WITH A MITRAL ANNULOPLASTY. AFTER 5 YEARS DUE TO EARLY DEGENERATION AND MITRAL DISEASE A TAVI WAS PERFORMED. A PERCEVAL PVS 23MM WAS USED AS A TAVI FOR PERIMOUNT AND A MOSAIC 27MM WAS IMPLANTED IN THE MITRAL VALVE. A PACEMAKER WAS IMPLANTED DUE TO AV BLOCK. SIX MONTHS LATER THE PATIENT WAS SUFFERING FROM ACUTE BACTERIAL ENDOCARDITIS RESULTING IN BIOPROSTHESIS DEGENERATION AND SEVERE HEART FAILURE WHICH WAS PARTIALLY CONTROLLED BY MEDICAL THERAPY. THE PATIENT WAS HOSPITALIZED AND DEVELOPED COVID. A CT SCAN DEMONSTRATED THE IN-FOLDING AREA OF THE PERCEVAL VALVE INSIDE THE PERIMOUNT VALVE. AFTER 2 MONTHS OF CARDIAC REHABILITATION A SECOND TAVI WAS PERFORMED, WHERE A SAPIEN 3 WAS IMPLANTED INSIDE THE PERCEVAL 23MM. AFTER BIOPROSTHESIS DEPLOYMENT THE PEAK-TO-PEAK LV AORTIC GRADIENT REDUCED FROM 51MMHG TO 16MMMHG. THE PATIENT WAS DISCHARGED IN GOOD CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174682 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR CORCYM CANADA CORP. PVS23

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention