BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2241815 · Received September 9, 2011

    Report

    Report Number
    9616099-2011-00716
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    February 17, 2009
    Report Date
    February 5, 2009
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE NOTIFICATION RECEIVED FOR THE (B)(4) STUDY INDICATED THAT APPROXIMATELY (B)(6) WEEKS POST INDEX PROCEDURE (PRECISE STENT PLACEMENT IN THE RICA), THE PATIENT UNDERWENT STENTING WITH A PRECISE STENT OF A KNOWN LESION IN THE CONTRALATERAL CAROTID ARTERY (LICA).THE INFORMATION STATES THAT THE STENT WAS DEPLOYED 5-7 MM DISTAL TO THE INTENDED TARGET LOCATION, BUT DID FULLY COVER THE LESION AND NO ADDITIONAL STENTS WERE PLACED. THE PATIENT IS A (B)(6) MALE WHO WAS INITIALLY ENROLLED IN THE (B)(4) STUDY FOR STENTING OF THE RIGHT INTERNAL CAROTID ARTERY. THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2009. THERE WERE NO ADVERSE EVENTS REPORTED DURING THE INDEX PROCEDURE. PRIOR TO THE INDEX PROCEDURE BILATERAL ARTERY STENOSIS AS DETERMINED BY ANGIOGRAPHY IN WHICH BOTH CAROTID ARTERIES REQUIRE TREATMENT WAS DIAGNOSED. APPROXIMATELY (B)(6) WEEKS POST INDEX PROCEDURE THE PATIENT UNDERWENT STENTING OF A KNOWN LESION IN THE CONTRALATERAL CAROTID ARTERY (LICA).THE CONTRALATERAL STENOSIS WAS LOCATED IN THE OSTIUM OF THE LICA. THE RATE OF STENOSIS WAS 80%. THE LENGTH OF THE LESION WAS 20 MM. THE LESION WAS DESCRIBED AS MILDLY TORTUOUS AND SEVERELY CALCIFIED. AN ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS POSITIONED DISTAL TO LESION AND A PRECISE STENT WAS DEPLOYED. THE DATABASE INFORMATION STATES THAT THE STENT WAS DEPLOYED 5-7 MM DISTAL TO THE CONTRALATERAL LESION. SINCE THE LESION WAS COVERED BY THE STENT NO ADDITIONAL STENTING WAS REQUIRED. THERE WAS NO DIFFICULTY DEPLOYING THE STENT. THERE WAS NO REPORTED ADVERSE EVENT TO THE PATIENT. THE PATIENT'S MEDICAL HISTORY INCLUDES FIRST-DEGREE RELATIVE WITH PREMATURE CAD, HYPERLIPIDEMIA, RENAL INSUFFICIENCY, DIABETES MELLITUS, CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION, AND HYPERTENSION. HIGH RISK CRITERIA INCLUDE UNSTABLE ANGINA AND A CONTRALATERAL CAROTID ARTERY OCCLUSION. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE NOTIFICATION RECEIVED FOR THE (B)(4) INDICATED THAT APPROXIMATELY FIVE WEEKS POST INDEX PROCEDURE (PRECISE STENT PLACEMENT IN THE RICA), THE PATIENT UNDERWENT STENTING WITH A PRECISE STENT OF A KNOWN LESION IN THE CONTRALATERAL CAROTID ARTERY (LICA). THE RECEIVED INFORMATION STATES THAT THE STENT WAS DEPLOYED 5-7MM DISTAL TO THE INTENDED TARGET LESION LOCATION, BUT DID COVER THE LESION. THE PATIENT IS A (B)(6) MALE WHO WAS INITIALLY ENROLLED IN THE (B)(6) FOR STENTING OF THE RIGHT INTERNAL CAROTID ARTERY. THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2009. THERE WERE NO ADVERSE EVENTS REPORTED DURING THE INDEX PROCEDURE. PRIOR TO THE INDEX PROCEDURE BILATERAL ARTERY STENOSIS AS DETERMINED BY ANGIOGRAPHY IN WHICH BOTH CAROTID ARTERIES REQUIRE TREATMENT WAS DIAGNOSED. APPROXIMATELY FIVE WEEKS POST INDEX PROCEDURE, THE PATIENT UNDERWENT STENTING OF A KNOWN LESION IN THE CONTRALATERAL CAROTID ARTERY (LICA). THE CONTRALATERAL STENOSIS WAS LOCATED IN THE OSTIUM OF THE LICA. THE RATE OF STENOSIS WAS 80%. THE LENGTH OF THE LESION WAS 20MM. THE LESION WAS DESCRIBED AS MILDLY TORTUOUS AND SEVERELY CALCIFIED. AN ANGIOGUARD ((B)(4) / LOT 71008507) EMBOLIC PROTECTION DEVICE WAS POSITIONED DISTAL TO LESION AND A PRECISE (PC0930RXC / LOT 14028018) WAS DEPLOYED. THE DATABASE INFORMATION STATES THAT THE STENT WAS DEPLOYED 5-7MM DISTAL TO THE CONTRALATERAL LESION. SINCE THE LESION WAS COVERED BY THE STENT NO ADDITIONAL STENTING WAS REQUIRED. THERE WAS NO DIFFICULTY DEPLOYING THE STENT. THERE WAS NO REPORTED ADVERSE EVENT TO THE PATIENT.

    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 14028018

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR ANGIOGUARD ((B)(4) / LOT 71008507)