BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORONARY SDS

    MDR report key: 1923281 · Received December 13, 2010

    Report

    Report Number
    1016427-2010-00150
    Event Type
    Death
    Date Received
    December 13, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P900043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT POST CORDIS STENT IMPLANTATION THE PATIENT DIED. THIS WAS A (B)(6) PATIENT OF UNKNOWN GENDER AND MEDICAL HISTORY. THERE IS NO INFORMATION AVAILABLE REGARDING STENT LOT OR CATALOGUE NUMBER, INTERVENTIONAL PROCEDURE OR TARGET VESSEL. AN UNKNOWN EVENT OCCURRED THAT RESULTED IN THE PATIENT'S DEATH. MULTIPLE ATTEMPTS TO GAIN FURTHER INFORMATION HAVE BEEN CONDUCTED; HOWEVER, NO OTHER DETAILS HAVE BEEN DISCOVERED TO DATE. NO PRODUCT HAS BEEN RETURNED FOR ANALYSIS. THERE IS NO CATALOGUE OR STERILE LOT NUMBER INFORMATION THUS NO DHR COULD BE PERFORMED. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE CORDIS SDS IFU'S (INSTRUCTIONS FOR USE) AS SUCH. IT IS NOT POSSIBLE TO COMPLETE A DHR ON THIS COMPLAINT. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. REVIEW OF THE EXTREMELY LIMITED INFORMATION DOES NOT ALLOW FOR A DETERMINATION OF CONTRIBUTING FACTORS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AN UNSPECIFIED HEALTHCARE PROFESSIONAL CALLED REQUESTING PATIENT INFORMATION AND ADDITIONALLY REPORTED AN ADVERSE EVENT. WHEN THE PATIENT WAS "(B)(6) ," AN UNSPECIFIED CORDIS STENT WAS PLACED IN AN UNSPECIFIED VESSEL FOR AN UNSPECIFIED REASON. ON, 2010-(B)(6), PATIENT EXPERIENCED AN UNKNOWN EVENT RESULTING IN DEATH. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORONARY SDS CORONARY SDS/STENTS MAF CORDIS CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death