BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3594791 · Received January 28, 2014

    Report

    Report Number
    9616099-2014-00052
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    August 19, 2013
    Report Date
    January 14, 2014
    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

    DURING THE INDEX PROCEDURE THE OPERATOR EXPERIENCED DEPLOYMENT DIFFICULTY WITH THE PRECISE STENT DELIVERY SYSTEM THAT RESULTED IN INACCURATE STENT PLACEMENT AS THE STENT BARELY COVERED THE LESION. THE TARGET LESION LOCATION WAS THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY. THE CHARACTERISTICS OF THE VESSEL WERE DESCRIBED AS NORMAL WITH AN 80% STENOSIS. THE PRODUCT LOOKED NORMAL WHEN TAKEN FROM THE PACKAGING, WERE PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THERE WAS NO DIFFICULTY ACCESSING THE LESION WITH THE ANGIOGUARD. THE LESION WAS NOT PRE-DILATED. THERE WAS NO DIFFICULTY TRACKING THE DEVICE THROUGH THE VESSEL TO GET TO THE LESION, OR CROSSING THE LESION. DURING DEPLOYMENT OF THE STENT, IT JUMPED AND BARELY COVERED THE LESION. THE LESION WAS SUCCESSFULLY TREATED AND IT DID NOT REQUIRE PLACEMENT OF AN ADDITIONAL STENT. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. REVIEW OF LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. 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 REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(6) REGISTRY DURING THE INDEX PROCEDURE, THE OPERATOR EXPERIENCED DEPLOYMENT DIFFICULTY WITH THE PRECISE DUE TO INACCURATE PLACEMENT. THE STENT BARELY COVERED LESION. THERE WERE NO ADVERSE EVENTS REPORTED. THE PATIENT IS A (B)(6) MALE. THE TARGET LESION LOCATION WAS THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY. THE CHARACTERISTICS OF THE VESSEL WERE DESCRIBED AS NORMAL. THE RATE OF STENOSIS WAS 80%. THE PRODUCTS LOOKED NORMAL WHEN TAKEN FROM THE PACKAGING. THE DEVICES WERE PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THERE WAS NO DIFFICULTY ACCESSING THE LESION WITH THE ANGIOGUARD. THE LESION WAS NOT PRE-DILATED. THERE WAS DIFFICULTY TRACKING THE DEVICE THROUGH THE VESSEL TO GET TO THE LESION, OR CROSSING THE LESION. DURING DEPLOYMENT OF THE STENT, IT JUMPED AND BARELY COVERED THE LESION. THE LESION WAS SUCCESSFULLY TREATED. ONLY ONE STENT WAS PLACED IN THE LESION AS THERE WAS NO NEED TO DEPLOY AN ADDITIONAL STENT. THERE WERE NO ADVERSE EVENTS REPORTED. THE PATIENT IS CURRENTLY IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60999 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15856326

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR ANGIOGUARD