BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1811557 · Received August 23, 2010

    Report

    Report Number
    9616099-2010-00637
    Event Type
    Death
    Date Received
    August 23, 2010
    Date of Event
    August 15, 2009
    Report Date
    August 2, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC FOR THE INDEX PROCEDURE. THE TARGET LESION FOR THE PROCEDURE WAS THE OSTIUM FOR THE LEFT INTERNAL CAROTID ARTERY. THE LESION WAS REPORTED TO BE: AN 81% STENOSIS, 20 MM LENGTH, 5.0 MM VESSEL DIAMETER, CONCENTRIC/MODERATELY CALCIFIED, AND ECCENTRIC. THE LESION WAS PRE-DILATED. AN ANGIOGUARD 6 MM EMBOLIC PROTECTION DEVICE WAS USED FOR THE PROCEDURE. A PRECISE 7 X 40 MM STENT WAS IMPLANTED. THE RESIDUAL STENOSIS WAS 33%. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR INSPECTION. THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT DURING THE INDEX PROCEDURE FOR PRECISE CAROTID STENT PLACEMENT, THE PHYSICIAN EXPERIENCED SOME DIFFICULTY REMOVING THE EMBOLIC CAPTURE WIRE OF THE ANGIOGUARD 6 MM EMBOLIC PROTECTION DEVICE. THE WIRE WAS REMOVED SUCCESSFULLY. NO DEBRIS WAS NOTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS ADMITTED ELEVEN DAYS POST INDEX PROCEDURE FOR APICAL AORTIC CONDUIT SURGERY FOR AORTIC STENOSIS AND EXPERIENCED VF TWELVE HOURS POST-OP. CPR WAS PERFORMED WITH PRESENTATION OF ANOXIC STROKE. IT WAS ALSO INDICATED THAT THE PATIENT HAD EVIDENCE OF PERIOPERATIVE COAGULOPATHY. CT DEMONSTRATED AN ACUTE LEFT HEMISPHERIC INFARCT INVOLVING BOTH ANTERIOR CEREBRAL ARTERY AND MIDDLE CEREBRAL ARTERY DISTRIBUTION AND SMALL ACUTE RIGHT FRONT VERTEX CORTICAL INFARCT. THE PATIENT DID NOT RESPOND TO PERIOPERATIVE CEREBROVASCULAR ACCIDENT MANAGEMENT AND EXPIRED EIGHT DAYS AFTER SURGERY. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC FOR THE INDEX PROCEDURE. THE TARGET LESION FOR THE PROCEDURE WAS THE OSTIUM FOR THE LEFT INTERNAL CAROTID ARTERY. THE LESION WAS REPORTED TO BE: AN 81% STENOSIS, 20 MM LENGTH, 5.0 MM VESSEL DIAMETER, CONCENTRIC/MODERATELY CALCIFIED, AND ECCENTRIC. THE LESION WAS PRE-DILATED. AN ANGIOGUARD 6 MM EMBOLIC PROTECTION DEVICE WAS USED FOR THE PROCEDURE. A PRECISE 7 X 40 MM STENT WAS IMPLANTED. THE RESIDUAL STENOSIS WAS 33%. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. AT INDEX PROCEDURE BASELINE, THE PATIENT'S HISTORY INCLUDED CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, CABG, 70% RIGHT INTERNAL CAROTID STENOSIS, AND HYPERTENSION (SYSTOLIC>140, OR DIASTOLIC>90, OR REQUIRING MEDICATION). HIGH RISK CRITERIA INCLUDED AGE > 75, REQUIREMENT OF SIMULTANEOUS OR STAGED CARDIAC VALVE SURGERY, PERIPHERAL VASCULAR SURGERY, OR AAA REPAIR WITHIN 60 DAYS AND FIRST-DEGREE RELATIVE WITH PREMATURE CAD (FEMALE 5 PACKS OF CIGARETTES). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH PRECISE LOT 14042527 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. STROKE IS A KNOWN RISK OF CAROTID ARTERY STENTING; HOWEVER, BASED ON THE AVAILABLE INFORMATION THE RELATIONSHIP OF THE DEVICE TO THE STROKE CANNOT BE DETERMINED. THIS PATIENT'S HISTORY OF AORTIC VALVE DISEASE REQUIRING SURGICAL INTERVENTION, POST OPERATIVE VENTRICULAR FIBRILLATION REQUIRING CPR, AND REPORTED EVIDENCE OF COAGULOPATHY ARE IDENTIFIED FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED STROKE. THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS AND MAY BE RELATED TO THE PATIENT'S COMORBIDITIES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT DURING THE INDEX PROCEDURE FOR PRECISE CAROTID STENT PLACEMENT, THE PHYSICIAN EXPERIENCED SOME DIFFICULTY REMOVING THE EMBOLIC CAPTURE WIRE OF THE ANGIOGUARD 6 MM EMBOLIC PROTECTION DEVICE. THE WIRE WAS REMOVED SUCCESSFULLY. NO DEBRIS WAS NOTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS ADMITTED FOR AORTIC VALVE REPLACEMENT SURGERY AND EXPERIENCED VENTRICULAR FIBRILLATION (VF) TWELVE HOURS AFTER SURGERY. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. THE PATIENT AFTERWARD SHOWED A DENSE LEFT CEREBROVASCULAR ACCIDENT (CVA) AND EXPIRED EIGHT DAYS AFTER SURGERY. IT WAS NOT KNOWN IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS 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 14042527

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H| L ANGIOGUARD 6 MM EMBOLIC PROTECTION DEVICE