BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1709601 · Received June 3, 2010

    Report

    Report Number
    9616099-2010-00427
    Event Type
    Death
    Date Received
    June 3, 2010
    Date of Event
    January 25, 2010
    Report Date
    May 14, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED VIA THE (B) (4) REGISTRY, THE PATIENT EXPIRED DUE TO AN UNKNOWN CAUSE APPROXIMATELY TEN MONTHS AFTER THE INDEX PROCEDURE. ACCORDING TO THE INVESTIGATOR, THE DEATH WAS NOT RELATED TO CORDIS PRODUCT. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% STENOSIS OF THE PROXIMAL LEFT VERTEBRAL ARTERY. THE LESION WAS DESCRIBED AS ECCENTRIC, MILDLY CALCIFIED AND 20MM IN LENGTH. THE REFERENCE VESSEL WAS 6MM IN DIAMETER. AN ANGIOGUARD RX WITH A 6MM BASKET WAS DEPLOYED BEYOND THE TARGET LESION, AND THE LESION WAS PRE-DILATED. A 9.0 X 40MM PRECISE RX STENT WAS IMPLANTED AT THE TARGET LESION WITH NO RESIDUAL STENOSIS. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITHOUT NEUROLOGICAL SYMPTOMS AND WAS DISCHARGED THE FOLLOWING DAY. INFORMATION ABOUT THE PATIENT'S DEATH WAS FOUND IN THE SOCIAL SECURITY DEATH INDEX AND NEWSPAPER CLIPPINGS. THE PATIENT'S PHONE NUMBER WAS DISCONNECTED AND THE CAUSE OF DEATH COULD NOT BE DETERMINED. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. 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. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B) (4) REGISTRY, A PATIENT EXPIRED DUE TO AN UNKNOWN CAUSE APPROXIMATELY TEN MONTHS AFTER THE INDEX PROCEDURE. INFORMATION ABOUT THE PATIENT'S DEATH WAS FOUND IN THE SOCIAL SECURITY DEATH INDEX AND NEWSPAPER CLIPPINGS. THE PATIENT'S PHONE NUMBER WAS DISCONNECTED AND THE CAUSE OF DEATH COULD NOT BE DETERMINED. ACCORDING TO THE INVESTIGATOR, THE DEATH WAS NOT RELATED TO CORDIS PRODUCT. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% STENOSIS OF THE PROXIMAL LEFT VERTEBRAL ARTERY. THE LESION WAS DESCRIBED AS ECCENTRIC, MILDLY CALCIFIED AND 20MM IN LENGTH. THE REFERENCE VESSEL WAS 6MM IN DIAMETER. AN ANGIOGUARD RX WITH A 6MM BASKET WAS DEPLOYED BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 9.0 X 40MM PRECISE RX STENT WAS IMPLANTED AT THE TARGET LESION WITH NO RESIDUAL STENOSIS. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITHOUT NEUROLOGICAL SYMPTOMS AND WAS DISCHARGED THE FOLLOWING DAY.

    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 14039630

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death