BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1891218 · Received November 4, 2010

    Report

    Report Number
    9616099-2010-00850
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 12, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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. REVIEW OF LOT 15195700 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ISCHEMIC 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 AMERICAN HEART ASSOCIATION AND AMERICAN STROKE ASSOCIATION (AHA/ASA) 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. THE MOST COMMON CAUSE OF INTRACEREBRAL HEMORRHAGE IS HIGH BLOOD PRESSURE (HYPERTENSION). SINCE HIGH BLOOD PRESSURE BY ITSELF OFTEN CAUSES NO SYMPTOMS, MANY PEOPLE WITH INTRACRANIAL HEMORRHAGE ARE NOT AWARE THAT THEY HAVE HIGH BLOOD PRESSURE, OR THAT IT NEEDS TO BE TREATED. LESS COMMON CAUSES OF INTRACEREBRAL HEMORRHAGE INCLUDE TRAUMA, INFECTIONS, TUMORS, BLOOD CLOTTING DEFICIENCIES, AND ABNORMALITIES IN BLOOD VESSELS (SUCH AS ARTERIOVENOUS MALFORMATIONS). REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT(S) ARE NOT AVAILABLE FOR ANALYSIS. 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 AND CONFIRMED THAT THE DEVICE(S) MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) REGISTRY: UPON ADMISSION THE PATIENT WAS SYMPTOMATIC WITH AN (B)(4) STROKE SCALE SCORE OF 3. THE TARGET LESION WAS A 95% STENOSIS IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. A 5MM ANGIOGUARD DEVICE WAS ADVANCED BEYOND THE LESION AND WAS DEPLOYED WITHOUT DIFFICULTY. AN 8.0 X 30MM PRECISE STENT WAS SUCCESSFULLY DEPLOYED. THERE WAS A 20% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY WITH A (B)(4) STROKE SCALE SCORE OF 3. ORDER WERE GIVEN FOR ASPIRIN AND PLAVIX DAILY. APPROXIMATELY THREE DAYS POST INDEX PROCEDURE THE PATIENT EXPERIENCED BEHAVIORAL CHANGES AND APHASIA. ONSET AND DURATION OF SYMPTOMS ARE UNKNOWN. DIAGNOSIS WAS ISCHEMIC STROKE. THIRTEEN (13) DAYS LATER THE PATIENT EXPERIENCED SUDDEN ONSET OF APHASIA. THE PATIENT WAS DIAGNOSED WITH HEMORRHAGIC STROKE. THE DURATION OF SYMPTOMS IS NOT KNOWN, BUT THERE IS EVIDENCE OF PERSISTENT RESIDUAL DEFICIT.

    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 15195700

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening| S ASPIRIN, PLAVIX