BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1005076 · Received February 29, 2008

    Report

    Report Number
    9616099-2008-00505
    Event Type
    Death
    Date Received
    February 29, 2008
    Date of Event
    January 22, 2008
    Report Date
    February 1, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE PT EXPERIENCED A NEUROLOGICAL DEFICIT (NOT RELATED TO ANTICOAGULATION) DESCRIBED AS BEHAVIORAL CHANGE AND APHASIA. THE PT ALSO SUFFERED FROM HEMIPARESIS AND HEMINEGLECT ON THE RIGHT SIDE. THIS WAS DIAGNOSED AS ISCHEMIC STROKE. THE PT ALSO SUFFERED A NON-Q WAVE MI. IT IS UNK IF THE EVENT OCCURRED DURING THE PROCEDURE AS ENZYMES WERE ELEVATED APPROX 16 HRS POST PROCEDURE. THE PT EXPIRED IN 2008. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFO TO BE SUBMITTED 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO CORDIS PRODUCTS THAT WAS INVOLVED IN THE SAME PROCEDURE AND IS RELATED TO MFG # 1016427-2008-00048 AND 9616099-2008-00505.

    Description of Event or Problem · 1

    THE PT SUFFERED A NON-Q WAVE MYOCARDIAL INFARCTION AND AN ISCHEMIC STROKE. THE PT EXPIRED IN 2008. THE CAUSE OF DEATH WAS RELATED TO NEUROLOGIC DEFICITS. A MALE WAS CONSENTED TO THE STUDY IN 2008. THE INDEX PROCEDURE WAS COMPLETED ON THE SAME DAY, AND THE PT WAS SYMPTOMATIC. THE TARGET LESION LOCATION WAS THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THERE WAS AN OCCLUSION IN THE CONTRALATERAL CAROTID. REFERENCE VESSEL DIAMETER WAS 6.0. TARGET LESION DIAMETER STENOSIS WAS 80% WITH LESION LENGTH 30MM. TOTAL LENGTH OF STENTED SEGMENT WAS 40MM. ACCESS WAS MADE AT THE RIGHT COMMON FEMORAL ARTERY. AN ARCH AORTOGRAM WAS COMPLETED AND REVEALED A TOTALLY OCCLUDED RIGHT INTERNAL CAROTID ARTERY. A SELECTIVE ANGIOGRAM OF THE LEFT INTERNAL CAROTID ARTERY REVEALED A 70-80% STENOSIS. IT ALSO REVEALED SIGNIFICANT PLAGUING OF THE PROXIMAL INTERNAL CAROTID STENOSIS. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS DEPLOYED PAST THE STENOTIC INTERNAL CAROTID LESION. NEXT, A PRECISE STENT WAS IMPLANTED AT THE ORIGIN OF THE LEFT ICA AND EXTENDED APPROX 4CM DISTALLY INTO THE INTERNAL CAROTID ARTERY. THERE WAS NO MALFUNCTION WITH THE STENT. POST-DEPLOYMENT ANGIOPLASTY WAS PERFORMED WITH A 6MM BALLOON. A POST PROCEDURE ANGIOGRAM WAS PERFORMED AND REVEALED LESS THAN 5% RESIDUAL STENOSIS. A CEREBRAL ANGIOGRAM WAS PERFORMED AND REVEALED NO EVIDENCE OF THROMBOEMBOLISM, SIGNIFICANT OCCLUSION, OR ANEURYSM. THE PROCEDURE WAS COMPLETED AND THE PT TOLERATED THE PROCEDURE WELL.

    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 13289912

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| H| L 6FR SHUTTLE SHEATH| 6MM BALLOON