BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1739876 · Received June 29, 2010

    Report

    Report Number
    9616099-2010-00490
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    September 13, 2009
    Report Date
    June 2, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDENDUM RECIEVED (B)(6) 2011: THE SOCIAL SECURITY DEATH INDEX RESULT INDICATED THE ACTUAL DATE OF DEATH WAS (B)(6) 2009.

    Additional Manufacturer Narrative · 1

    WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 14010906 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE (B) (4) STUDY. THE PATIENT WAS A WHITE FEMALE WITH A HISTORY OF SYNCHRONOUS, SEVERE CARDIAC AND CAROTID DISEASE REQUIRING OPEN-HEART SURGERY AND CAROTID REVASCULARIZATION, ABNORMAL STRESS TEST, SMOKING (>5PACKS OF CIGARETTES), DIABETES, CORONARY ARTERY DISEASE AND HYPERTENSION. THE TARGET LESION WAS THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY. PRE-PROCEDURE STENOSIS WAS 80%. LESION LENGTH WAS 20MM AND DIAMETER WAS 5MM. THE LESION WAS MODERATELY CALCIFIED AND PRE-DILATED. A PRECISE PRO RX 9 X 40MM STENT WAS IMPLANTED. POST-PROCEDURE STENOSIS WAS 5%. AN ANGIOGUARD, SIZE 6, WAS SUCCESSFULLY DEPLOYED AND RETRIEVED DURING THE PROCEDURE. AN ABBOTT EMBOLIC PROTECTION DEVICE WAS ALSO USED. THE PATIENT HAD NO NEUROLOGICAL DEFICIT WHEN HE LEFT THE ANGIOGRAPHY SUITE. THE PATIENT WAS DISCHARGED 2 DAYS LATER. APPROXIMATELY 4 MONTHS POST-PROCEDURE, THE PATIENT DIED. THE DEATH WAS NOTED AS UNRELATED TO THE INDEX PROCEDURE AND CORDIS PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 14010906

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death ASPIRIN, CLOPIDOGREL