BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1911844 · Received December 1, 2010

    Report

    Report Number
    9616099-2010-00902
    Event Type
    Death
    Date Received
    December 1, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 5, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND 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. AS ENDORSED BY 2009 GUIDELINES FROM THE (B)(6) ISCHEMIC STROKE IS DEFINED AS AN INFRACTION OF CENTRAL NERVOUS SYSTEM TISSUE. 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. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THIS PATIENT WAS ADMITTED FOR CAROTID ANGIOGRAPHY. THE PATIENT WAS ASYMPTOMATIC WITH A STROKE SCALESCORE OF 0 WHEN ADMITTED. ANGIOGRAPHY REVEALED A 90%, 10MM LESION IN THE PROXIMAL LEFT CAROTID ARTERY. THE VESSEL WAS MODERATELY CALCIFIED AND MILDLY TORTUOUS. A 6MM ANGIOGUARD DEVICE WAS ADVANCED BEYOND THE TARGET, AND THE BASKET WAS DEPLOYED WITHOUT COMPLICATION. IT IS NOT KNOWN IF THE LESION WAS PREDILATED. AN 8.0 X 30MM PRECISE STENT WAS DEPLOYED IN THE TARGET SITE WITHOUT COMPLICATION. RESIDUAL STENOSIS WAS 10%. SOMETIME AFTER THE PROCEDURE, THE PATIENT DEVELOPED RIGHT FACIAL DROOP, APHASIA AND DYSARTHRIA. THERE WAS INITIALLY QUESTION OF RIGHT UPPER EXTREMITY WEAKNESS ALSO. MRI SCAN CONFIRMED CVA. HE WAS DISCHARGED TO HIS HOME COMMUNITY SKILLED NURSING CARE FACILITY ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT WAS EXAMINED IN THE NURSING HOME BY HIS MEDICAL PROVIDER AFTER CONTACTED BY THE NURSING STAFF WHEN THE PATIENT HAD STARTED VOMITING AND PULLED OUT HIS NG TUBE. NG TUBE WAS REINSERTED AND THE PATIENT WATCHED CLOSELY FOR ASPIRATION PNEUMONIA. THE PATIENT, HOWEVER, BECAME PROGRESSIVELY WEAKER AND DEHYDRATED EVEN WITH TUBE FEEDINGS RESTARTED AND WAS EXAMINED BY MEDICAL PROVIDER AGAIN ON (B)(6) 2010. THE PATIENT WAS THOUGHT TO HAVE ASPIRATION PNEUMONIA AND SEPSIS, HOSPITAL ADMISSION WAS RECOMMENDED, AND THE PATIENT TRANSPORTED TO THE COMMUNITY HOSPITAL ER. ENROUTE TO THE HOSPITAL, THE PATIENT SUDDENLY DECOMPENSATED, AND DEVELOPED ACUTE RESPIRATORY DISTRESS, WITH COMPLETE HEART RATE AND RESPIRATORY CESSATION BY ARRIVAL TO THE ER, WHERE HE WAS PRONOUNCED DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15036727

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| L| R