BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1911592 · Received December 1, 2010

    Report

    Report Number
    9616099-2010-00900
    Event Type
    Death
    Date Received
    December 1, 2010
    Date of Event
    October 26, 2009
    Report Date
    November 4, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORAMTION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    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 13320407 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. TWO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. WITH THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE EMAIL RECEIVED FOR THE (B)(4) CLINICAL STUDY INDICATED THAT POST INDEX PROCEDURE, AND STENT DEPLOYMENT, THE PATIENT EXPERIENCED A SUDDEN BEHAVIORAL CHANGE. HE FULLY RECOVERED, WITH NO DEFICIT. THE TARGET SITE WAS A 70%, 20MM RECURRENT RESTENOSIS (FOLLOWING CAROTID ENDARTERECTOMY) IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS CONCENTRIC. THE SITE WAS NOT PREDILATED. A 7MM ANGIOGUARD DISTAL EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET SITE. A 9.0 X 30MM PRECISE STENT WAS DEPLOYED WITHOUT DIFFICULTY; HOWEVER, RESIDUAL STENOSIS REMAINED 70% POST STENT DEPLOYMENT. APPROXIMATELY SEVEN MONTHS LATER, THE PATIENT DIED. THE CAUSE OF DEATH IS NOT KNOWN. THE PHYSICIAN LISTED CEREBROVASCULAR DISEASE, ATHEROSCLEROSIS AND DIABETES ALL AS CAUSES OF DEATH. THE FAMILY DR'S OFFICE STATED THEY HAD NOT SEEN HIM FOR SEVERAL MONTHS SO THEY WERE NOT SURE OF ALL THE DETAILS. THE DEATH CERTIFICATE IS NOT AVAILABLE.

    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 13320407

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death