BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 7659053 · Received July 3, 2018

    Report

    Report Number
    2015691-2018-02596
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 6, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    IN THIS CASE, MINIMAL INFORMATION REGARDING THIS EVENT WAS RECEIVED. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IN THIS CASE, A ¿DEMO STOCK ONLY NOT FOR HUMAN USE¿ LABEL WAS APPLIED TO THE SHELF BOX OF A VALVE BY THE (B)(4) QA PREMATURELY (BEFORE ITS EXPIRATION DATE), IN EXPECTATION OF IT NOT BEING USED, BEFORE IT WAS SENT OUT BY DHL TO THE CUSTOMER. THIS EVENT RESULTED IN DHL UPDATING THEIR PROCEDURE AND RE-TRAINING HAS BEEN COMPLETED. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 19MM PERICARDIAL AORTIC VALVE, WITH A LABELED STICKER INDICATING "DEMO STOCK ONLY" NOT FOR HUMAN USE, WAS INCORRECTLY SHIPPED TO THE CUSTOMER. THE VALVE HAD A SHORT EXPIRATION DATE OF LESS THAN TWO MONTHS LABELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500962 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX19MM

    Patients

    Seq Age Sex Outcome Treatment
    1