BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE SDS SELF EXPANDING

    MDR report key: 3903159 · Received June 30, 2014

    Report

    Report Number
    9616099-2014-00430
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    January 1, 2004
    Report Date
    June 6, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K012993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 UPON RECEIPT. PLEASE REFERENCE MFR. REPORT # 9616099-2014-00430, # 9616099-2014-00431, AND # 9616099-2014-00432.

    Additional Manufacturer Narrative · 1

    AS REPORTED IN A LITERATURE ARTICLE ENTITLED: SAFETY OF LATEST-GENERATION SELF-EXPANDING STENTS IN PATIENTS WITH NASCET-INELIGIBLE SEVERE SYMPTOMATIC EXTRACRANIAL INTERNAL CAROTID ARTERY STENOSIS, ONE PATIENT WHO WAS NOT ADEQUATELY ANTICOAGULATED WITH HEPARIN EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA) IMMEDIATELY POST PROCEDURE (CAS WITH A PRECISE STENT). THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. MANUFACTURING RECORDS (DHR) COULD NOT BE REVIEWED, AS THE PRODUCT CATALOG AND LOT NUMBER ARE NOT AVAILABLE. TIA IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU AS SUCH. TIA IS OFTEN ASSOCIATED WITH A TEMPORARY STOPPAGE OR SLOWING OF BLOOD FLOW TO THE CEREBRAL ARTERIES. THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY COLLECT IN THE EMBOLIC PROTECTION DEVICE OR FLOW DOWNSTREAM POTENTIALLY DISRUPTING PERFUSION BOTH DURING AND AFTER CAROTID STENT IMPLANTATION. BY DEFINITION ((B)(6)), THE SYMPTOMS OF A TIA MAY LAST UP TO 24 HOURS, BUT THEY OFTEN LAST ONLY A FEW MINUTES. TIA OCCURS WHEN THE BLOOD SUPPLY TO PART OF THE BRAIN IS BRIEFLY INTERRUPTED. TIA SYMPTOMS ARE SIMILAR TO THOSE OF STROKE BUT DO NOT LAST AS LONG. MOST SYMPTOMS OF A TIA DISAPPEAR WITHIN AN HOUR. WITHOUT THE RETURN OF THE ACTUAL COMPLAINT PRODUCT THE EVENT REPORTED BY THE CUSTOMER CANNOT BE CONFIRMED, NOR CAN ANY CONCLUSION REGARDING ROOT CAUSE BE DRAWN. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. THIS IS ONE OF THREE REPORTS FROM THE SAME LITERATURE ARTICLE. PLEASE REFERENCE MFR. REPORT # 9616099-2014-00430, # 9616099-2014-00431, AND # 9616099-2014-00432.

    Description of Event or Problem · 1

    DURING A LITERATURE REVIEW, AS NOTED IN THE PUBLICATION BY LINFANTE ET AL SAFETY OF LATEST-GENERATION SELF-EXPANDING STENTS IN PATIENTS WITH NASCET-INELIGIBLE SEVERE SYMPTOMATIC EXTRACRANIAL INTERNAL CAROTID ARTERY STENOSIS, ARCH NEUROL. 61 (2004) 39-43. ONE PATIENT WHO WAS NOT ADEQUATELY ANTICOAGULATED WITH HEPARIN EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA) IMMEDIATELY POST PROCEDURE (CAS WITH A PRECISE STENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380891 PRECISE SDS SELF EXPANDING SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening