BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2985259 · Received March 1, 2013

    Report

    Report Number
    9616099-2013-00110
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    April 27, 2009
    Report Date
    February 8, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHATOUROS ET AL CEREBRAL HYPERPERFUSION SYNDROME POST-CAROTID ARTERY STENTING; JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY; 53 (2009) 81-86; REPORT A CASE WHERE IMMEDIATELY POST-PROCEDURE AFTER DEPLOYMENT OF AN 8X40MM PRECISE PRO RX STENT, SYSTOLIC BLOOD PRESSURE WAS 150 MMHG 2 H POST-PROCEDURE THE PATIENT DEVELOPED A DENSE LEFT HEMIPLEGIA AND AN URGENT CT SCAN SHOWED A MASSIVE INTRACEREBRAL HAEMATOMA IN THE RIGHT (IPSILATERAL) CEREBRAL HEMISPHERE WITH INTRAVENTRICULAR EXTENSION AND COMPRESSION OF THE BRAINSTEM. UNFORTUNATELY, DUE TO THE LARGE MASS EFFECT, THE PATIENT DIED THE NEXT DAY. THE PATIENT INITIALLY PRESENTED WITH DYSARTHRIA AND LEFT-SIDED WEAKNESS, WHICH RESOLVED WITHIN 24 H. THE MRI OF THE BRAIN SHOWED A FEW TINY FOCI OF INFARCTS IN THE RIGHT SUBCORTICAL WATERSHED DISTRIBUTION. CAROTID ARTERY STENTING WAS CARRIED OUT 3 WEEKS AFTER PRESENTATION UNDER LOCAL ANAESTHETIC. ANGIOGRAPHY SHOWED A 95% STENOSIS OF THE SYMPTOMATIC RIGHT ICA ORIGIN WITH A PREOCCLUSIVE LEFT INTERNAL CAROTID. AN EZ FILTER WAS DEPLOYED BEYOND THE STENOSIS AND A PRECISE 8 MM - 40 MM STENT WAS DEPLOYED. THE STENT WAS THEN DILATED WITH A 5.5-MM BALLOON WITH RESTORATION OF THE LUMEN TO NORMAL SIZE. HEPARIN WAS THEN DISCONTINUED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. CEREBRAL HYPERPERFUSION SYNDROME (CHS) IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CAROTID STENTS. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EVENT DATE AND DATE OF DEATH INDICATED ARE ATTRIBUTED TO THE DATE OF THE PUBLICATION OF THE JOURNAL ARTICLE. PHATOUROS ET AL CEREBRAL HYPERPERFUSION SYNDROME POST-CAROTID ARTERY STENTING; JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY; 53 (2009) 81-86. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    PHATOUROS ET AL CEREBRAL HYPERPERFUSION SYNDROME POST-CAROTID ARTERY STENTING; JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY; 53 (2009) 81-86; REPORT A CASE WHERE IMMEDIATELY POST-PROCEDURE AFTER DEPLOYMENT OF AN 8X40MM PRECISE PRO RX STENT, SYSTOLIC BLOOD PRESSURE WAS 150 MMHG. 2 H POST-PROCEDURE THE PATIENT DEVELOPED A DENSE LEFT HEMIPLEGIA AND AN URGENT CT SCAN SHOWED A MASSIVE INTRACEREBRAL HAEMATOMA IN THE RIGHT (IPSILATERAL) CEREBRAL HEMISPHERE WITH INTRAVENTRICULAR EXTENSION AND COMPRESSION OF THE BRAINSTEM (FIG. 4). UNFORTUNATELY, DUE TO THE LARGE MASS EFFECT, THE PATIENT DIED THE NEXT DAY. THE PATIENT INITIALLY PRESENTED WITH DYSARTHRIA AND LEFT-SIDED WEAKNESS, WHICH RESOLVED WITHIN 24 H. THE MRI OF THE BRAIN SHOWED A FEW TINY FOCI OF INFARCTS IN THE RIGHT SUBCORTICAL WATERSHED DISTRIBUTION (FIG. 1A,B). CAROTID ARTERY STENTING WAS CARRIED OUT 3 WEEKS AFTER PRESENTATION UNDER LOCAL ANAESTHETIC. ANGIOGRAPHY SHOWED A 95% STENOSIS OF THE SYMPTOMATIC RIGHT ICA ORIGIN (FIG. 2) WITH A PREOCCLUSIVE LEFT INTERNAL CAROTID. AN EZ FILTER WAS DEPLOYED BEYOND THE STENOSIS AND A PRECISE 8 MM _ 40 MM STENT WAS DEPLOYED. THE STENT WAS THEN DILATED WITH A 5.5-MM BALLOON WITH RESTORATION OF THE LUMEN TO NORMAL SIZE. HEPARIN WAS THEN DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89668 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS NIM CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death