BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 1659284 · Received April 15, 2010

    Report

    Report Number
    9616099-2010-00274
    Event Type
    Injury
    Date Received
    April 15, 2010
    Date of Event
    February 22, 2010
    Report Date
    March 17, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K041796
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN THE KOREAN J RADIOLOGY. 2010 MAR¿APR; 11(2): 156¿163. PUBLISHED ONLINE 2010 FEBRUARY 22. DOI: 10.3348/KJR.2010.11.2.156., IN USE OF SELF-EXPANDING STENTS FOR THE TREATMENT OF VERTEBRAL ARTERY OSTIAL STENOSIS: A SINGLE CENTER EXPERIENCE, AFTER DEPLOYMENT OF A 5X40MM PRECISE STENT IN THE LEFT VERTEBRAL ARTERY, A SECOND STENT WAS REQUIRED BECAUSE OF THE MISPLACEMENT OF THE FIRST STENT. THE MAIN CAUSE OF MISPLACEMENT WAS DISTAL JUMPING OF THE STENT, THEREBY FAILING TO COVER THE MOST STENOTIC PORTION OF THE LESION, WHICH WAS AT THE OSTIUM. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) MAY INVOLVE ADDITIONAL RISKS NOT DESCRIBED IN THE LABELING. 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. WITH THE LIMITED AMOUNT OF 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

    AS REPORTED IN THE KOREAN J RADIOLOGY. 2010 MAR¿APR; 11(2): 156¿163. PUBLISHED ONLINE 2010 FEBRUARY 22. DOI: 10.3348/KJR.2010.11.2.156., IN USE OF SELF-EXPANDING STENTS FOR THE TREATMENT OF VERTEBRAL ARTERY OSTIAL STENOSIS: A SINGLE CENTER EXPERIENCE, AFTER DEPLOYMENT OF A 5X40MM PRECISE STENT IN THE LEFT VERTEBRAL ARTERY, A SECOND STENT WAS REQUIRED BECAUSE OF THE MISPLACEMENT OF THE FIRST STENT. THE MAIN CAUSE OF MISPLACEMENT WAS DISTAL JUMPING OF THE STENT, THEREBY FAILING TO COVER THE MOST STENOTIC PORTION OF THE LESION, WHICH WAS AT THE OSTIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention