BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE SDS SELF EXPANDING

    MDR report key: 3903174 · Received June 30, 2014

    Report

    Report Number
    9616099-2014-00432
    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, A STROKE OCCURRED IN A PATIENT WHO HAD A LESS THAN 2-CM DIAMETER ANTERIOR CEREBRAL ARTERY INFARCTION CONTRALATERAL TO THE PRECISE STENT PLACEMENT. THE PATIENT RECOVERED COMPLETELY IN ONE WEEK. AT 6 MONTHS AFTER CAS, THE PATIENT¿S MODIFIED RANKIN SCALE SCORE WAS 3. NO ADDITIONAL INFORMATION WAS AVAILABLE. 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. STROKE/ISCHEMIC STROKE/CEREBROVASCULAR ACCIDENT IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND IS LISTED IN THE IFU AS SUCH. IT CAN BE DEFINED AS A CEREBROVASCULAR DISORDER CAUSED BY DEPRIVATION OF BLOOD FLOW TO AN AREA OF THE BRAIN, GENERALLY AS A RESULT OF THROMBOSIS, EMBOLISM, OR REDUCED BLOOD PRESSURE. THE ACT OF STENT EXPANSION OR POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY TRAVEL UPSTREAM TO THE CEREBRAL ARTERIES POTENTIALLY DISRUPTING PERFUSION. THIS ACT, INHERENT TO THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A BLOOD VESSEL THAT IS NOT BLOCKED, BUT IS EXTREMELY NARROWED, CAN ALSO CAUSE AN ISCHEMIC STROKE. THE BLOCKED OR NARROWED ARTERIES DEPRIVE BRAIN CELLS OF OXYGEN AND NUTRIENTS, LEADING TO NERVE CELL DEATH. 80% OF ALL STROKES ARE ISCHEMIC. DURING ISCHEMIC STROKE, DIMINISHED BLOOD FLOW INITIATES A SERIES OF EVENTS (CALLED ISCHEMIC CASCADE) THAT MAY RESULT IN ADDITIONAL, DELAYED DAMAGE TO BRAIN CELLS. EARLY MEDICAL INTERVENTION CAN HALT THIS PROCESS AND REDUCE THE RISK FOR IRREVERSIBLE COMPLICATIONS. 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. A STROKE OCCURRED IN A PATIENT WHO HAD A LESS THAN 2-CM DIAMETER ANTERIOR CEREBRAL ARTERY INFARCTION CONTRALATERAL TO THE PRECISE STENT PLACEMENT. THE PATIENT RECOVERED COMPLETELY IN ONE WEEK. AT 6 MONTHS AFTER CAS, THE PATIENT¿S MODIFIED RANKIN SCALE SCORE WAS 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380911 PRECISE SDS SELF EXPANDING SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening