BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2051213 · Received April 12, 2011

    Report

    Report Number
    9616099-2011-00241
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    May 19, 2010
    Report Date
    March 18, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. 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 15033427 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15033427.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY THREE MONTHS AFTER HAVING A STENT PLACED IN PROXIMAL RIGHT INTERNAL CAROTID ARTERY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. THE PATIENT WAS SYMPTOMATIC PRIOR TO THE INDEX PROCEDURE. THE LESION WAS DESCRIBED AS NON-THROMBOSED, 65% STENOSED, 10MM IN LENGTH, CONCENTRIC, ARCH TYPE II, WITH MILD CALCIFICATION. THE REFERENCE VESSEL WAS 6.0MM IN DIAMETER AND MILDLY TORTUOUS. A 7MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. NO PRE-DILATION WAS PERFORMED. A PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. THE ANGIOGUARD RX WAS RETRIEVED WITH NO DEBRIS NOTED IN THE BASKET. RESIDUAL STENOSIS WAS 0%. THERE WERE NO AIR BUBBLES PRESENT. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. THREE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED DYSARTHRIA AND WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THERE WAS NO VISION LOSS, HEMIPARESIS, HEMINEGLECT, OR HEMIATAXIA. THE ONSET WAS DESCRIBED AS STEP-LIKE. RECOVERY WAS PARTIAL WITH MINOR RESIDUAL. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR THE INDEX PROCEDURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. THE PATIENT'S MEDICAL HISTORY INCLUDES TRANSIENT ISCHEMIC ATTACK, STROKE, HYPERLIPIDEMIA, HYPERTENSION, AND HIGH RISK FOR HIGH CERVICAL INTERNAL CAROTID ARTERY LESIONS OR COMMON CAROTID ARTERY LESIONS BELOW THE CLAVICLE. 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 15033427 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ISCHEMIC STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT THE PATIENT'S SIGNIFICANT MEDICAL HISTORY LIKELY CONTRIBUTED TO THE REPORTED EVENT. 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, THE PATIENT EXPERIENCED AN ISCHEMIC STROKE APPROXIMATELY THREE MONTHS AFTER THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY (ICA). THE PATIENT WAS SYMPTOMATIC PRIOR TO THE INDEX PROCEDURE. THE LESION WAS DESCRIBED AS NON-THROMBOSED, 65% STENOSED, 10MM IN LENGTH, CONCENTRIC, ARCH TYPE II, WITH MILD CALCIFICATION. THE REFERENCE VESSEL WAS 6.0MM IN DIAMETER AND MILDLY TORTUOUS. A 7MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. NO PRE-DILATION WAS PERFORMED. A 9X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. THE ANGIOGUARD RX WAS RETRIEVED WITH NO DEBRIS NOTED IN THE BASKET. RESIDUAL STENOSIS WAS 0%. THERE WERE NO AIR BUBBLES PRESENT. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. THREE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED DYSARTHRIA AND WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THERE WAS NO VISION LOSS, HEMIPARESIS, HEMINEGLECT, OR HEMIATAXIA. THE ONSET WAS DESCRIBED AS STEP-LIKE. RECOVERY WAS PARTIAL WITH MINOR RESIDUAL. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR THE INDEX PROCEDURE.

    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 15033427

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization 7MM ANGIOGUARD RX