BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1964026 · Received January 19, 2011

    Report

    Report Number
    9616099-2011-00047
    Event Type
    Death
    Date Received
    January 19, 2011
    Date of Event
    September 23, 2009
    Report Date
    December 21, 2009
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE ADJUDICATION MINUTES RECEIVED (B)(6) 2011 NOTES THAT THE CAUSE OF THE PATIENT'S DEATH WAS DETERMINED AS NEUROLOGICAL IN ORIGIN. IT HAD PREVIOUSLY BEEN DETERMINED AS CARDIAC. THE PATIENT IS AN (B)(6) MALE WHO WAS CONSENTED TO THE (B)(4) FOR STENTING OF THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND THE OSTIUM OF THE RCA. THE STENOSIS WAS 85%. THE PATIENT HAS A MEDICAL HISTORY OF SMOKING, CORONARY ARTERY DISEASE, AND HYPERTENSION. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS USED IN THE PROCEDURE. THE LESION WAS PRE-DILATED AND A PRECISE STENT WAS SUCCESSFULLY PLACED IN THE LESION. THE ANGIOGUARD WAS REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET. THE PATIENT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. THE PATIENT WAS DISCHARGED THE NEXT DAY. 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 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/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION. HOWEVER, THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    THE ORIGINAL CAUSE OF DEATH WAS LISTED AS CARDIAC. ADJUDICATION NOTES WERE RECEIVED DISAGREEING WITH THE PREVIOUS DIAGNOSIS AS REPORTED BY THE SITE BUT STATING THAT THE DEATH WAS NEUROLOGICAL IN ORIGIN. THE ORIGINAL REPORT RECEIVED FROM THE (B)(4) STUDY STATED THAT THIS (B)(6) MALE PATIENT WAS CONSENTED TO THE (B)(4) STUDY FOR STENTING OF THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND THE OSTIUM OF THE RCA. THE STENOSIS WAS 85%. THE PATIENT HAS A MEDICAL HISTORY OF SMOKING, CORONARY ARTERY DISEASE, AND HYPERTENSION. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS USED IN THE PROCEDURE. THE LESION WAS PRE-DILATED AND A PRECISE (PC0830RXC / LOT 14003080) STENT WAS SUCCESSFULLY PLACED IN THE LESION. THE ANGIOGUARD WAS REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET. THE PATIENT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. THE PATIENT WAS DISCHARGED THE NEXT DAY. ADDITIONAL INFORMATION NOTED THAT PRE-PROCEDURE, THE PATIENTS (B)(6) STROKE SCALE SCORE WAS 0 AND THE (B)(6) SCORE 0. POST-PROCEDURE, THE (B)(6) WAS 0 AND THE (B)(6) WAS 0. THE SITE REPORTED NO POST-PROCEDURE COMPLICATIONS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL. AT THE 30-DAY FOLLOW-UP THE (B)(6) WAS 0 AND THE (B)(6) WAS 0.

    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 14003080

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death