BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2222632 · Received August 25, 2011

    Report

    Report Number
    9616099-2011-00670
    Event Type
    Death
    Date Received
    August 25, 2011
    Date of Event
    April 26, 2011
    Report Date
    July 28, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. CONCOMITANT DEVICES INCLUDE 6MM ANGIOGUARD RX AND UNKNOWN BALLOON CATHETER. AS REPORTED BY (B)(4) STUDY, THE PATIENT EXPIRED AT UNKNOWN TIME AFTER THE INDEX PROCEDURE. THE CAUSE OF DEATH WAS CARDIAC ARRHYTHMIA. NO AUTOPSY WAS PERFORMED AND NO DEATH CERTIFICATE WAS AVAILABLE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (ICA). THE PATIENT WAS DESCRIBED AS HAVING EXPRESSIVE APHASIA PRIOR TO THE PROCEDURE. THE LESION WAS DESCRIBED AS 90% STENOSED, 20MM IN LENGTH, ARCH TYPE II, ECCENTRIC, NON-THROMBOSED, WITH MILD CALCIFICATION. THE REFERENCE VESSEL WAS 5.0MM IN DIAMETER AND MILDLY TORTUOUS. A 6MM ANGIOGUARD WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. THE LESION WAS PRE-DILATED WITH AN UNKNOWN BALLOON CATHETER AND AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. THE ANGIOGUARD WAS RETRIEVED WITH NO 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. THE PATIENT'S MEDICAL HISTORY INCLUDES TRANSIENT ISCHEMIC ATTACK, SYNCHRONOUS, SEVERE CARDIAC AND CAROTID DISEASE REQUIRING OPEN-HEART SURGERY AND CAROTID REVASCULARIZATION, SEVERE PULMONARY DISEASE, CLINICAL PULMONARY DISEASE, CLINICAL CHRONIC OBSTRUCTIVE PULMONARY DISEASE, SMOKING, CORONARY ARTERY DISEASE AND HYPERTENSION. HIGH RISK CRITERIA INCLUDE HIGH CERVICAL INTERNAL CAROTID ARTERY LESIONS OR COMMON CAROTID ARTERY LESIONS BELOW THE CLAVICLE AND KNOWLEDGE OF TWO OR MORE PROXIMAL OR MAJOR DISEASE CORONARY ARTERIES WITH > 70% STENOSIS THAT HAVE NOT OR CANNOT BE REVASCULARIZED. 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 15319752 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ONE UNIT WAS REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNIT WAS 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. NO EXCURSIONS WERE FOUND FOR LOT 15319752. A DHR REVIEW WAS REQUESTED TO NITINOL DEVICES & COMPONENTS (NDC), FOR PART NUMBER: (B)(4) AND STENT LOT NUMBERS 528186, 528185, 528184, 527336 & 527080; AND THE RESULTS INDICATE THAT THE STENT SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. 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. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, THE PATIENTS SIGNIFICANT MEDICAL HISTORY MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, THE PATIENT DIED AFTER THE INDEX PROCEDURE. THE CAUSE OF DEATH WAS CARDIAC ARRHYTHMIA. NO AUTOPSY WAS PERFORMED AND NO DEATH CERTIFICATE WAS AVAILABLE. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (ICA). THE PATIENT WAS DESCRIBED AS HAVING EXPRESSIVE APHASIA PRIOR TO THE PROCEDURE. THE LESION WAS DESCRIBED AS 90% STENOSED, 20MM IN LENGTH, ARCH TYPE II, ECCENTRIC, NON-THROMBOSED, WITH MILD CALCIFICATION. THE REFERENCE VESSEL WAS 5.0MM IN DIAMETER AND MILDLY TORTUOUS. A 6MM ANGIOGUARD WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. THE LESION WAS PRE-DILATED WITH AN UNKNOWN BALLOON CATHETER AND AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. THE ANGIOGUARD WAS RETRIEVED WITH NO 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. AFTER THE INDEX PROCEDURE, THE PATIENT DIED. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT.

    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 15319752

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death