BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2233091 · Received September 2, 2011

    Report

    Report Number
    9616099-2011-00704
    Event Type
    Death
    Date Received
    September 2, 2011
    Date of Event
    March 5, 2010
    Report Date
    May 23, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY (B)(4) STUDY, APPROXIMATELY TWO WEEKS AFTER THE INDEX PROCEDURE, THE PATIENT DIED A NATURAL DEATH AS A RESULT OF COMPLICATIONS OF MULTIPLE MEDICAL PROBLEMS. THE PATIENT'S MEDICAL HISTORY INCLUDES STROKE, RIGHT AND LEFT ENDARTERECTOMY, FIRST DEGREE RELATIVE WITH PREMATURE CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, CORONARY ARTERY BYPASS GRAFT SURGERY, NON-INSULIN DEPENDENT DIABETES MELLITUS, CORONARY ARTERY DISEASE AND HYPERTENSION. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT INTERNAL CAROTID ARTERY (ICA). THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. THE ADJUDICATION MINUTES NOTES THAT ETIOLOGY OF THE PATIENTS DEATH APPROXIMATELY TWO WEEKS AFTER THE INDEX PROCEDURE WAS NEUROLOGICAL IN ORIGIN AND THAT IT WAS RELATED TO BOTH THE IMPLANTED DEVICE AND THE PROCEDURE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. 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, PROCEDURAL, 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

    AS REPORTED BY (B)(4) STUDY, APPROXIMATELY TWO WEEKS AFTER THE INDEX PROCEDURE THE PATIENT DIED OF UNKNOWN CAUSES. ADJUDICATION MINUTES RECEIVED ON (B)(6) 2011 NOTED THE CAUSE OF DEATH AS NEUROLOGICAL IN ORIGIN AND THAT IT WAS RELATED TO BOTH THE IMPLANTED DEVICE AND THE PROCEDURE. THEREFORE, THE EVENT WILL NOW BE A REPORTABLE EVENT. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT INTERNAL CAROTID ARTERY (ICA). THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. THE LESION WAS DESCRIBED AS PREVIOUSLY TREATED VIA CAROTID ENDARTERECTOMY. THE LESION WAS DESCRIBED AS 95% STENOSED, ARCH TYPE II, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS NON-TORTUOUS. THE LESION LENGTH AND REFERENCE VESSEL DIAMETER WERE UNKNOWN. A 5MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. THE LESION WAS PRE-DILATED WITH A 5.0X20MM AVIATOR PLUS BALLOON CATHETER AND A 6X40MM PRECISE PRO RX STENT WAS IMPLANTED. THE ANGIOGUARD WAS SUCCESSFULLY RETRIEVED. IT WAS UNKNOWN IF THERE WAS DEBRIS NOTED IN THE BASKET. RESIDUAL STENOSIS WAS 20%. THERE WERE NO AIR BUBBLES PRESENT DURING THE PROCEDURE. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. APPROXIMATELY TWO WEEKS AFTER THE INDEX PROCEDURE, THE PATIENT DIED OF UNKNOWN CAUSES. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR THE INDEX PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THE DEATH CERTIFICATE REPORTED THE CAUSE OF DEATH AS "COMPLICATIONS OF MULTIPLE MEDICAL PROBLEMS". PER THE DEATH CERTIFICATE, AN AUTOPSY WAS NOT PERFORMED. THE PATIENT PASSED AWAY AT HOME SO HOSPITAL RECORDS WERE 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 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death 5MM ANGIOGUARD RX