BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2001764 · Received February 25, 2011

    Report

    Report Number
    9616099-2011-00142
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 8, 2011
    Report Date
    January 8, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 6 X 30 MM PRECISE PRO COULD NOT CROSS THE LESION. DURING ANALYSIS IT WAS NOTED THAT THE STENT WAS RECEIVED PARTIALLY DEPLOYED 1.5 CM. 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. ONE NON STERILE PRECISE 6 MM X 30 MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE STENT WAS RECEIVED PARTIALLY DEPLOYED 1.5 CM. THE VALVE WAS RECEIVED CLOSE. NO MORE ANOMALIES WERE FOUND. THE OUTER DIAMETER (OD) OF THE SDS WAS MEASURED AT SEVERAL LOCATIONS AND IT WAS FOUND TO BE WITHIN SPECIFICATION. DURING ANALYSIS WITH THE PROXIMAL VALVE CLOSED, THE INNER LUMEN COULD NOT BE DEPLOYED AVOIDING A POSSIBLE STENT PREMATURE DEPLOYMENT. REVIEW OF LOT 15060624 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE FAILURE TO CROSS REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED DURING ANALYSIS SINCE NO ANOMALIES WERE FOUND ON THE UNIT. THE CAUSE OF THE STENT PARTIALLY DEPLOYED COULD NOT BE DETERMINED. CONTROLS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURE FROM LEAVING THE FACILITY. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME, SINCE THE CAUSE OF THE PREMATURE DEPLOYMENT DOES NOT APPEAR TO BE MANUFACTURING RELATED. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY THE OPERATIONAL CONTEXT OF THE DEVICE, PROCEDURAL FACTORS AND/OR VESSEL CHARACTERISTICS AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A 6 X 30MM PRECISE PRO COULD NOT CROSS THE LESION. DURING ANALYSIS IT WAS NOTED THAT THE STENT WAS RECEIVED PARTIALLY DEPLOYED 1.5 CM. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS NIM CORDIS DE MEXICO NA 15060624

    Patients

    Seq Age Sex Outcome Treatment
    1