BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1431571 · Received August 4, 2009

    Report

    Report Number
    9616099-2009-01322
    Event Type
    Death
    Date Received
    August 4, 2009
    Date of Event
    July 23, 2008
    Report Date
    July 9, 2009
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. CEREBRAL HYPERPERFUSION SYNDROME (CHS) IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CAROTID STENTS. THE LITERATURE INDICATES THAT CEREBRAL HYPERFUSION SYNDROME/ INTRACEREBRAL HEMORRHAGE HAS BEEN INCREASINGLY REPORTED AS A COMPLICATION OF CAROTID ANGIOPLASTY AND STENT PLACEMENT. NUMEROUS REPORTS HAVE SUBSEQUENTLY DOCUMENTED THE RISK OF HYPERPERFUSION SYNDROME AFTER CAROTID ENDARTERECTOMY, AFTER CAROTID ANGIOPLASTY AND AFTER INTRACRANIAL ANGIOPLASTY. ESTIMATES OF THE INCIDENCE OF HYPERPERFUSION SYNDROME AFTER CAROTID REVASCULARIZATION RANGE UP TO 3%. TYPICALLY, INTRACEREBRAL HEMORRHAGE DEVELOPS ON THE THIRD TO FIFTH POSTOPERATIVE DAY, THOUGH THERE HAVE BEEN CASES OBSERVED IMMEDIATELY AFTER SURGERY, AS WELL AS CASES DEVELOPED 3 WEEKS AFTER REVASCULARIZATION. EVIDENCE FROM OBSERVATIONAL STUDIES, IN LACK OF RANDOMIZED TRIALS, SUGGESTS THAT A NUMBER OF FACTORS-ALL REFERABLE TO HEMODYNAMIC EXHAUSTION OF THE CEREBRAL CIRCULATION-PLAY A ROLE, SUCH AS RECENT STROKE, SURGERY FOR VERY TIGHT INTERNAL CAROTID ARTERY STENOSIS, CONCOMITANT CONTRALATERAL TIGHT LESION, IMPAIRED CEREBROVASCULAR RESERVE (CEREBRAL HYPOPERFUSION), AND MARKED POSTOPERATIVE INCREASE OF THE IPSILATERAL PEAK MIDDLE CEREBRAL ARTERY FLOW VELOCITY IN ADDITION TO PRE- AND POSTOPERATIVE HYPERTENSION. CEREBRAL HYPERPERFUSION IS AN INHERENT RISK OF THE PROCEDURE AND MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. REVIEW OF THE AVAILABLE INFO SUGGEST THAT PT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE SAME DAY AFTER HAVING TWO STENTS PLACED IN A MODERATELY CALCIFIED AND HEAVILY STENOSED LEFT INTERNAL CAROTID ARTERY, THE PT DEVELOPED HYPOTENSION. EPHEDRINE HYDROCHLORIDE AND DOPAMINE HYDROCHLORIDE WERE ADMINISTERED AND THE PT RECOVERED WITHIN A DAY. APPROXIMATELY 27 DAYS LATER, THE PT RETURNED TO THE HOSPITAL WITH CONVULSIONS AT WHICH TIME A STROKE WAS DIAGNOSED DUE TO A BILATERAL BRAIN HEMORRHAGE. EIGHT DAYS LATER, THE PT EXPIRED. ACCORDING TO THE PHYSICIAN, HYPERPERFUSION SYNDROME CONTRIBUTED TO THE BRAIN HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE OTW NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13391182

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| H| R PERCUSURGE EPD