BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2016814 · Received March 14, 2011

    Report

    Report Number
    2015691-2011-15027
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 18, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED.ADDITIONAL MANUFACTURER NARRATIVE:A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS.NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. INVESTIGATION IS ON-GOING.

    Additional Manufacturer Narrative · 1

    CONDITION OF RETURN: RECEIVED THE VALVE IN ITS ORIGINAL JAR AND PACKAGING. THE VALVE IS ATTACHED TO THE HOLDER AND THE BLUE SERIAL TAG. THE USE BY DATE IS (B)(6) 2011. EVALUATION SUMMARY: AS COMPARED TO A CONTROL SAMPLE OF GLUTARALDEHYDE, THE RETURNED SAMPLE FROM THE CUSTOMER WAS CONFIRMED TO BE YELLOW AND TURBID. A VISUAL EXAMINATION WAS CONDUCTED. THE GLUTARALDEHYDE SOLUTION IS YELLOW IN APPEARANCE. THERE WERE NO VISIBLE PARTICLES PRESENT IN THE SOLUTION OR ON THE VALVE. THE GLUTARALDEHYDE SOLUTION WAS SENT TO CHEMISTRY FOR TESTING AND EXAMINATION. CHEMISTRY CONFIRMED THAT NO VISIBLE MACROSCOPIC PARTICULATES WERE NOTED. THE SAMPLE TURBIDITY RESULTS MEASURED TO 0.636 NTU AS COMPARED TO A CONTROL SAMPLE OF GLUTARALDEHYDE, WHICH MEASURED TO 0.129 NTU. EVALUATION METHODOLOGY: THE RETURNED DEVICE WAS EXAMINED VISUALLY. THE TURBIDITY RESULTS OF THE GLUTARALDEHYDE SOLUTION WERE OBTAINED BY AN OUTSIDE TEST LAB.

    Additional Manufacturer Narrative · 1

    TO DATE, WE HAVE BEEN UNSUCCESSFUL IN GETTING THIS PRODUCT MOVED THROUGH (B)(6). THEREFORE, NO PRODUCT HAS BEEN RECEIVED FOR EVALUATION. ON (B)(6) 2011, THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE RELATED TO THIS EVENT. THE SURGEON DID RESPOND STATING THAT THERE DID NOT EXIST ANY COMPLICATIONS WITH THE PATIENT; HOWEVER, HE WOULD NOT PROVIDE ANY PATIENT INFORMATION.

    Description of Event or Problem · 1

    PER SALES REPS FOLLOW UP WITH THE SURGEON, IT WAS LEARNED THAT THIS WAS DETECTED DURING THE SURGERY PREPARATION; THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GLUTARADEHYDE LOOKS TURBID, YELLOW AND WITH SMALL FRAGMENTS..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 07G171

    Patients

    Seq Age Sex Outcome Treatment
    1