BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT® AORTIC PERICARDIAL BIOPROSTHESIS

    MDR report key: 2091381 · Received May 17, 2011

    Report

    Report Number
    2015691-2011-15547
    Event Type
    Death
    Date Received
    May 17, 2011
    Date of Event
    January 23, 2011
    Report Date
    April 20, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROCESS. IT IS ASSUMED THAT THE DEVICE REMAINS IMPLANTED AS NO EXPLANT INFORMATION WAS MADE AVAILABLE AND THERE IS NO REPORT OF AN AUTOPSY. THE CAUSE OF DEATH HAS NOT BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN THE SOURCE DOCUMENTS, BUT NONE HAVE BEEN RECEIVED. HOWEVER, RESPONSE FROM HOSPITAL INDICATED THAT THE PATIENT UNDERWENT SURGICAL AORTIC VALVE REPLACEMENT AND DIED JUST SHY OF HIS 3-YEAR FOLLOW-UP, SO DEATH WOULD NOT BE ATTRIBUTABLE TO PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS LEARNED THOUGH A CLINICAL STUDY: REPORTEDLY, THE PATIENT HAD A HEART VALVE REPLACEMENT ON (B)(6) 2008. THE PATIENT EXPIRED ON (B)(6) 2011. IT IS UNKNOWN (NOT ASSESSED) IF THE DEATH WAS DEVICE RELATED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT® AORTIC PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700 R-08A0033

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death