BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1649537 · Received April 2, 2010

    Report

    Report Number
    2015691-2010-13029
    Event Type
    Death
    Date Received
    April 2, 2010
    Date of Event
    January 8, 2010
    Report Date
    March 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 04/29/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER VIA FAX), A RESPONSE WAS RECEIVED. UNFORTUNATELY, THE CAUSE OF DEATH WAS NOT PROVIDED. THE OPERATIVE REPORT OF (B) (6) 2010 WAS ALSO PROVIDED, HOWEVER, THE CAUSE OF DEATH COULD NOT BE LEARNED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED; (B) (4). TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA FAX) FOR THE OPERATIVE REPORT AND ADDITIONAL INFORMATION REGARDING THE DEVICE AND EVENT; HOWEVER, NO RESPONSE WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN ISSUE WITH FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. UPON VISUAL INSPECTION OF THE RETURNED PRODUCT, A CRACK/FRACTURE WAS OBSERVED ON THE TRANSMITTER. IT HAS BEEN DETERMINED THAT SOME FREESTYLE NAVIGATOR TRANSMITTERS COULD POTENTIALLY EXHIBIT A CRACK/FRACTURE ON THE PLASTIC HOUSING NEAR THE BATTERY COMPARTMENT, WHICH COULD POTENTIALLY ALLOW MOISTURE TO COME IN CONTACT WITH THE TRANSMITTER'S INTERNAL ELECTRONICS, POTENTIALLY CAUSING THE TRANSMITTER AND THE RECEIVER TO LOSE CONNECTION INTERRUPTING THE CONTINUOUS GLUCOSE RESULTS. ALTHOUGH UNLIKELY, MOISTURE ENTERING THE TRANSMITTER HAS THE POTENTIAL TO GENERATE INACCURATE RESULTS ONLY WITH THE CONTINUOUS GLUCOSE READINGS. THE BUILT-IN FREESTYLE GLUCOSE METER IS NOT IMPACTED BY THIS ISSUE AND THE USER CAN CONTINUE TO USE THE BUILT-IN METER. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD). DURING THE INDEX PROCEDURE, THE PHYSICIAN COULD NOT CROSS THE LESION WITH A 2.75X 28MM TAXUS LIBERTE STENT. WHILE ATTEMPTING TO CROSS THE LESION, IT WAS NOTED THAT STENT DAMAGE OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURY OR COMPLICATION WAS NOTED. PATIENT CONDITION LISTED AS "GOOD."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.1 MONTHS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-09K2363

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death