BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 1884386 · Received October 27, 2010

    Report

    Report Number
    2015691-2010-14264
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    June 2, 2010
    Report Date
    September 27, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION (ON 09/29/2010 AND 10/06/2010); HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION. 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)(4). SIZING ISSUE. ADDITIONAL MANUFACTURER NARRATIVE: THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE OPERATIVE REPORT WAS RECEIVED. IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO A SIZING ISSUE. PER THE OPERATIVE REPORT: "THE ANNULUS BARELY SIZED TO A 25 MM MITRAL PROSTHESIS. AN ATTEMPT WAS MADE TO IMPLANT THIS, HOWEVER, ONCE THE ANNULUS SUTURES HAD BEEN PLACED AND PASSED THROUGH THE SEWING RING, THE VALVE COULD NOT BE SEATED DUE TO THE SIGNIFICANT AMOUNT OF CALCIUM OF THE ANNULUS. SOME OF THE ANNULUS WAS DEBRIDED AS MUCH AS COULD BE SAFELY REMOVED, HOWEVER, THE VALVE STILL COULD NOT DEBRIDED. THIS REQUIRED THE VALVE TO BE TAKEN OUT." THE VALVE WAS REPLACED WITH A SMALLER SIZE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS. THE REASON FOR EXPLANTING THE DEVICE WAS NOT PROVIDED. NO FURTHER DETAILS WERE REPORTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ERRONEOUS ELEVATED PROSTATE SPECIFIC ANTIGEN (PSA) RESULT FOR ONE PATIENT GENERATED BY UNICEL DXI 800 ACCESS CHEMISTRY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. SINCE THE INITIAL SAMPLE HAD INADEQUATE AMOUNT OF VOLUME, A REPEAT TEST WAS CONDUCTED ON A SECOND SAMPLE AND LOWER RESULTS WERE OBTAINED WHICH BETTER MATCHED THE PATIENT'S CLINICAL PICTURE. THE CUSTOMER DID NOT RECEIVE ANY REPORTS OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH HIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX R-10A0127

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention