BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS BIOPROSTHESIS

    MDR report key: 1827432 · Received September 7, 2010

    Report

    Report Number
    2015691-2010-14023
    Event Type
    Death
    Date Received
    September 7, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 10, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P870056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL HAS BEEN UNABLE TO CONFIRM THE IMPLANT (B)(4) (DEVICE 1) OR (B)(4)(DEVICE 2). THEREFORE, THE DHR REVIEW HAS BEEN COMPLETED FOR BOTH DEVICES. FOR DEVICE #1 AND DEVICE #2, THE DHR REVIEW WAS COMPLETED. THESE DEVICES PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. AN EXHAUSTIVE SEARCH OF ALL DEVICES IN THE MANUFACTURING AND STERILIZATION LOTS WAS COMPLETED AND THERE ARE NO OTHER REPORTS OF THE SAME COMPLICATION.DEVICE NO. 1:(B)(4).LOT #: R-09H1885.EXPIRATION DATE: 08/12/2013.APPROXIMATE AGE OF DEVICE: 11 MONTHS.DEVICE MANUFACTURER DATE: 08/27/2009.UNKNOWN IF THIS IS THE DEVICE WAS USED. NO NEW INFORMATION RELEASED BY THE HOSPITAL.DEVICE NO. 2:(B)(4).LOT #: R-09H1999.EXPIRATION DATE: 08/25/2013.APPROXIMATE AGE OF DEVICE: 10 MONTHS.DEVICE MANUFACTURER DATE: 09/04/2009.UNKNOWN IF THIS IS THE DEVICE WAS USED. NO NEW INFORMATION RELEASED BY THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    THE HOSPITAL HAS REPORTED THE EVENT ONLY AND HAS NOT REQUESTED CONFIRMATION OR A CUSTOMER LETTER WITH OUR FINDINGS. A REPORT WILL BE SENT TO OUR AFFILIATE WITH THE RESULTS OF INVESTIGATION. HOSPITAL HAS NOT REPORTED ANY ADDITIONAL INFORMATION. ALTHOUGH ASKED, THE TYPE AND SOURCE OF INFECTION HAS NOT BEEN DISCLOSED. SEVERAL REQUESTS HAVE BEEN MADE BY THE SALES REP FOR ADDITIONAL INFORMATION WITH NO RESPONSE FROM THE HOSPITAL. REQUEST WAS MADE FOR A COPY OF THE DEATH CERTIFICATE AND FOR A PATHOLOGY REPORT. NONE HAS BEEN PROVIDED. NO DEVICE WILL BE RETURNED AS IT IS UNKNOWN IS AN AUTOPSY WAS CONDUCTED OR IF THE DEVICE HAS BEEN EXPLANTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. THIS WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. (B)(4). EXACT NUMBER HAS NOT BEEN CONFIRMED. REPEATED REQUESTS BY THE SALES REP AND COUNTRY MANAGER FOR CONFIRMATION HAVE GONE UNANSWERED. THE HOSPITAL RECORDS HAVE REPORTEDLY BEEN SEALED. THE DHR REVIEW FOR BOTH DEVICES HAS BEEN STARTED. A SEARCH OF OUR DATABASE HAS BEEN COMPLETED, AND THERE ARE NO OTHER REPORTS OF INFECTION ASSOCIATED WITH ANY OTHER DEVICE LISTED IN THE STERILIZATION LOTS FOR THESE TWO SERIAL NUMBERS. THE DHR REVIEW IS IN PROCESS.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT SHE JUST RECEIVED A FREESTYLE FREEDOM LITE METER. CUSTOMER REPORTED THERE WAS A READING IN METER'S MEMORY THAT WAS NOT HERS. CUSTOMER ALSO REPORTED BECAUSE OF THE METER ISSUE, SHE EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA. CUSTOMER FURTHER REPORTED VISITING HER DOCTOR WHO DIAGNOSED CUSTOMER WITH SEVERE HYPERGLYCEMIA AND STARTED CUSTOMER ON A NEW ORAL DIABETES MEDICATION. NO EMERGENT THIRD-PARTY MEDICAL INTERVENTION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF 0.03 MONTHS. PER THE CUSTOMER REPORT, THE VALVE WAS IMPLANTED (B)(6) 2010. PATIENT PRESENTED "WITH HIGH FEVER (40C) POST-OP WITH DEATH ON (B)(6) 2008. MEDICATION: CEPHALOSPORIN (SPECIFIC TYPE AND DOSAGE UNKNOWN) USED AFTER OPERATION; NAPROSEN SODIUM, CLYSIS THERAPY AND ICE BAG USED FOR HYPERTHERMIA (CHILL APPEARED WITH A COOLING BLANKET); PATIENT WAS ANTICOAGULATED WITH WARFARIN SODIUM, IV 1.25 MG Q.D.. THE PATIENT WAS WITH BARLOW'S DISEASE BEFORE OPERATION AND B ULTRASONIC TESTING FOUND HER WITH LARGER LA AND RV."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6625

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| H