BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2132500 · Received June 17, 2011

    Report

    Report Number
    9616099-2011-00425
    Event Type
    Death
    Date Received
    June 17, 2011
    Date of Event
    January 23, 2011
    Report Date
    May 25, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THE CAUSE OF DEATH AS RESPIRATORY FAILURE. THEREFORE, THIS COMPLAINT WILL BE UNREPORTED AS IT WILL NO LONGER BE DEEMED MDR REPORTABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, THE PATIENT DIED APPROXIMATELY ELEVEN MONTHS AFTER THE INDEX PROCEDURE. THE CAUSE OF DEATH WAS UNKNOWN. THE TARGET LESION WAS LOCATED IN THE RIGHT COMMON CAROTID ARTERY (CCA). THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. THE LESION WAS DESCRIBED AS 96% STENOSED, 11MM IN LENGTH, NON-THROMBOSED, ARCH TYPE II, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 8.0MM IN DIAMETER AND MILDLY TORTUOUS. NO PRE-DILATION WAS DONE. A 5MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION AND A 9X30MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. THE ANGIOGUARD RX WAS REMOVED WITH NO DEBRIS NOTED IN THE BASKET. RESIDUAL STENOSIS WAS 4%. THERE WERE NO AIR BUBBLES PRESENT DURING THE PROCEDURE. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. ELEVEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DIED. THE CAUSE OF DEATH WAS UNKNOWN. THE PATIENT'S PHYSICIAN OFFICE AND SOCIAL SECURITY INDEX CONFIRMED THE DEATH. THE PATIENT'S WIFE DIED SHORTLY AFTERWARDS AND THE SITE HAD NO OTHER CONTACT INFORMATION TO FIND OUT THE CAUSE OF DEATH. THE INVESTIGATOR'S CAUSALITY WAS NOT PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATING THE DEATH SUMMARY CONFIRMED RESPIRATORY FAILURE AS CAUSE OF DEATH. THERE WERE NO INDICATION OF ISSUES WITH NEUROLOGICAL EVENT OR STENTING. THE SITE REPORTED THE PATIENT HAD A SURGICAL PROCEDURE FOR LOWER EXTREMITY PERIPHERAL ARTERY DISEASE (PAD) WITH SUBSEQUENT ABOVE THE KNEE AMPUTATION. THE PATIENT WAS UNABLE TO BE WEANED FROM THE VENTILATOR AND SUBSEQUENTLY DIED DUE TO RESPIRATORY FAILURE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death 5MM ANGIOGUARD