BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1741726 · Received June 30, 2010

    Report

    Report Number
    9616099-2010-00497
    Event Type
    Death
    Date Received
    June 30, 2010
    Date of Event
    June 21, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 14035801 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE CAUSE OF DEATH IS UNKNOWN. THE PATIENT HAD BEEN CONSIDERED LOST TO FOLLOW-UP AND THE NOTICE OF DEATH WAS OBTAINED FROM THE NATIONAL DEATH INDEX. THERE HAS BEEN NO RESPONSE TO FOLLOW-UP FROM THE PATIENT'S FAMILY. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND REPORT OF THE PATIENT'S DEMISE. THERE IS NO INDICATION THE EVENT IS MANUFACTURING RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COUPLER WAS BROKEN ON THE FRONT OF THE MOTOR DRIVE UNIT. THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE AND THERE WAS NO PT INVOLVEMENT.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE (B) (4) STUDY. THE PATIENT WAS A (B) (6) MALE, (B) (6), WITH A HISTORY OF HYPERLIPIDEMIA, CARDIAC ARRHYTHMIA, CABG, SMOKING, DIABETES, CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION, AND HYPERTENSION. THE TARGET LESION WAS THE LEFT PROXIMAL INTERNAL CAROTID. PRE-PROCEDURE STENOSIS WAS 60%. THE VESSEL WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS. LESION LENGTH WAS 30MM AND DIAMETER WAS 4.5MM. THE LESION WAS PRE-DILATED. A PRECISE PRO RX 10 X 40 WAS DEPLOYED AT THE TARGET LESION. POST-PROCEDURE STENOSIS WAS 5%. AN ANGIOGUARD XP, BASKET SIZE 7 WAS UNABLE TO TRACK TO THE LESION AND FAILED TO CROSS. THE DEVICE PREPPED NORMALLY AND THERE WAS NO BOX/PACKAGE FAILURE. A GUIDANT EMBOLIC PROTECTION DEVICE WAS USED INSTEAD. THERE WAS NO PATIENT ADVERSE EVENT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ADDENDUM RECEIVED 6/2/2010: THE PATIENT DIED ON (B) (6)-2009. THE CAUSE OF DEATH IS UNKNOWN. THE PATIENT HAD BEEN CONSIDERED LOST TO FOLLOW-UP AND THE NOTICE OF DEATH WAS OBTAINED FROM THE NATIONAL DEATH INDEX. THERE HAS BEEN NO RESPONSE TO FOLLOW-UP FROM THE PATIENT'S FAMILY.

    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 14035801

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death ASPIRIN AND CLOPIDOGREL