BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1983010 · Received February 10, 2011

    Report

    Report Number
    2015691-2011-14762
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 12, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.ADDITIONAL MANUFACTURER NARRATIVE:THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    (B)(6) 2011, RECEIVED TWO FILAMENTS FROM CUSTOMER. FILAMENT #1, ASSIGNED TO WHAT CUSTOMER CLAIMED AS "UNKNOWN THREAD-LIKE FIBER, WAS OBSERVED FROM THE SEWING CUFF AS THE MAGNA (B)(4) WAS BEING SLID DOWN DURING THE IMPLANT." FILAMENT #1, MEASURED TO BE APPROXIMATELY 4.5 CM. FILAMENT #2 WAS ASSIGNED TO THE OTHER RETURNED THREAD. IT MEASURED TO APPROXIMATELY 11.5 CM. IT HAS BEEN SEVERED EVENLY AT OPPOSITE ENDS. IT IS THICKER IN DIAMETER RELATIVE TO THE OTHER RETURNED FILAMENT. IT IS ALSO A MULTIFILAMENT THREAD, WHICH HAS SIMILAR CHARACTERISTICS TO SURGICAL THREADS COMMONLY OBSERVED IN RETURNED EXPLANTED VALVES. THIS OBSERVATION OF THE RETURNED THREAD, WHICH WAS ASSIGNED AS FILAMENT #2, STRONGLY SUGGESTS THAT IT IS THE SUTURE THREAD USED IN SURGERY SENT FOR "COMPARISON REASONS". EW QUALITY ENGINEER PROVIDED AN EDWARDS FILAMENT FROM MANUFACTURING PROCESS TO COMPARE IT AGAINST FILAMENT #1 AND FILAMENT #2. EDWARDS FILAMENT IS A PTFE SEWING THREAD. FILAMENTS #1 AND #2 WERE ALSO SENT TO CHEMISTRY LABORATORY AND AN IR SPECTRUM WAS CONDUCTED. CHEMISTRY CONCLUDED WITH THE FOLLOWING: TWO TYPES OF WHITE FILAMENT WERE SUBMITTED BY PRODUCT EVALUATION FOR MATERIAL IDENTIFICATION. THE IR SPECTRUM OF THE FIRST FILAMENT (FILAMENT #1) SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO POLYTETRAFLUORETHYLENE ( PTFE) LIKE MATERIAL. THE IR SPECTRUM OF THE SECOND WHITE FILAMENT (FILAMENT #2) SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO POLYESTER LIKE MATERIAL." THUS, THE CHEMISTRY REPORT CONFIRMED THAT THE "UNKNOWN THREAD" IS SIMILAR IN MATERIAL TO EDWARD PTFE SEWING THREAD. FILAMENTS #1 AND #2 WERE EXAMINED VISUALLY AND WITH A DIGITAL MICROSCOPE WITH 40X MAGNIFICATION LENS AND WITH A 100X MAGNIFICATION LENS. THE FILAMENTS WERE COMPARED VISUALLY AGAINST EDWARDS FILAMENT. INITIALLY, THE EXAMINATION INDICATED FILAMENT #1 HAD DIFFERENT PHYSICAL CHARACTERISTICS THAN EDWARDS PTFE SEWING THREAD. FILAMENT #1 INITIALLY APPEARED TO BE WIDER AND OF MULTIPLE FILAMENTS WHILE EDWARDS PTFE SEWING THREAD APPEARED TO BE THINNER AND UNIFORMED. EDWARDS PTFE SEWING THREAD WAS THEN SUBJECTED TO VARIOUS TYPES OF EXTERNAL PRESSURE. UPON PULLING EDWARDS PTFE AGAINST A BLADE A FEW TIMES, THE APPEARANCE OF THE DISTORTED EDWARDS FILAMENT BECAME ALMOST IDENTICAL TO FILAMENT #1. EW QUALITY ENGINEER AND EW PRINCIPAL QUALITY ENGINEER REVIEWED THE CHEMISTRY ANALYSIS AND VIEWED THE EVALUATION PICTURES. EDWARDS ENGINEERS CANNOT RULE OUT THE POSSIBILITY THAT FILAMENT #1, THE UNKNOWN FILAMENT, ORIGINATED FROM EDWARDS MANUFACTURING PROCESS. HOWEVER, THEY ALSO BELIEVE THAT IN OPERATION 50, THE FINAL INSPECTION AFTER HOLDER ATTACHMENT, WHICH IS PERFORMED UNDER A MICROSCOPE, WOULD IDENTIFY A THREAD THAT IS 4CM. EDWARDS ENGINEERS SUGGEST THE POSSIBILITY THAT FILAMENT #1 MAY HAVE BEEN PULLED FROM THE DEVICE DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN THREAD-LIKE FIBER WAS OBSERVED FROM THE SEWING CUFF WHEN THE DEVICE WAS BEING IMPLANTED. THE FIBER WAS CLEARLY DIFFERENT FROM THE SUTURE USED FOR THE IMPLANT. THE DEVICE REMAINS IMPLANTED AND ONLY THE FIBER AND THE SUTURE THAT WAS USED IN THE SURGERY FOR COMPARISON WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 10J196

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R