BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 12426016 · Received September 3, 2021

    Report

    Report Number
    2015691-2021-05033
    Event Type
    Injury
    Date Received
    September 3, 2021
    Date of Event
    January 23, 2020
    Report Date
    October 19, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IT WAS LEARNED THAT THE PATIENT'S PULMONARY VALVE ITSELF WASN'T CORRECTED, ONLY THE NON-EDWARDS STENTED RIGHT PULMONARY ARTERY THE VALVE IS SEATED IN. BASED ON THE NEW INFORMATION RECEIVED, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE. THERE IS NO INDICATION OR EVIDENCE OF DEVICE MALFUNCTION OR SERIOUS INJURY RELATED TO THE EDWARDS VALVE.

    Description of Event or Problem · 0

    IT WAS LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE IMPLANTED IN PULMONARY POSITION FOR FOUR (4) YEARS AND ONE (1) MONTH UNDERWENT A VALVULOPLASTY FOR AN UNKNOWN REASON. THE PATIENT HARM, OR OUTCOME IS NOT KNOWN. SUBSEQUENT MEDICAL RECORDS DENOTED THAT AN ANGIOPLASTY OF THE STENTED (NON-EDWARDS) RIGHT PULMONARY ARTERY DUE TO STENOSIS CAUSED BY AN ACUTE ANGLE OF VESSEL, PRIOR TO THE PULMONARY VALVE. THE PROCEDURE WENT WELL. THERE WAS NO INDICATION THAT THE PULMONARY VALVE ITSELF WAS REPAIRED/CORRECTED. THERE WAS NO COMPLICATIONS AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION ON THE SAME OPERATIVE DAY.

    Additional Manufacturer Narrative · 1

    THERE MAY BE CASES WHEN A TRANSCATHETER INTERVENTION IS INDICATED OR PERFORMED. ALTHOUGH THERE ARE MULTIPLE ROOT CAUSES, VALVES ARE TYPICALLY TREATED BECAUSE THEY ARE NOT FUNCTIONING OPTIMALLY. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. IF ANY ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 19MM 3300TFX AORTIC VALVE IMPLANTED IN PULMONARY POSITION FOR FIVE (4) YEARS AND ONE (1) MONTH UNDERWENT A VALVULOPLASTY FOR AN UNKNOWN REASON. A VSD AND INTERRUPTED AORTIC ARCH REPAIR AND A NORWOOD/RASTELLI PROCEDURE WAS COMPLETED. THE PATIENT HARM, OR OUTCOME IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319591 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| L| R