BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2681158 · Received August 3, 2012

    Report

    Report Number
    9616099-2012-00404
    Event Type
    Injury
    Date Received
    August 3, 2012
    Date of Event
    June 7, 2012
    Report Date
    July 11, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT ALTHOUGH THIS IS A CORRECTION TO THE ALERT DATE, EVEN WITH THE CORRECTION, THE PRIOR 3500A SUPPLEMENTAL MEDWATCH REPORT WAS SUBMITTED ON TIME.

    Additional Manufacturer Narrative · 1

    AS IT WAS REPORTED BY THE (B)(6) DATA BASE, A PATIENT PRESENTED WITH A NON-Q WAVE MYOCARDIAL INFARCTION TWO DAYS AFTER THE PROCEDURE, BEFORE BEING DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS AT THE FACILITY FOR AN ANGIOGRAPHY PROCEDURE WITH MEDICAL HISTORY OF STROKE (NHI SCALE SCORE OF 2), CORONARY ARTERY DISEASE, HYPERTENSION AND BILATERAL ARTERY STENOSIS. THE PROCEDURE WAS PERFORMED TO TREAT A CONCENTRIC MILD TORTUOUS AND MODERATE CALCIFIED RIGHT INTERNAL CAROTID ARTERY OSTIUM WITH A 95% STENOSIS. THE DEVICE USED WAS A PRECISE PRO RX, WHICH WAS IMPLANTED WITHOUT ANY PROBLEMS. THE PATIENT STARTED PRESENTING RECURRENT ISCHEMIC PAIN. CARDIAC ENZYMES CAME BACK SHOWING ((B)(6) 2012): CK (UL: 397): 877 AND CKMB (UL: 5.1 UG/L): 14.0 UG/L AND THE ECG ((B)(6) 2012) SHOWED A NON-Q WAVE MI. 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 15580906 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT OF CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INVASIVE PROCEDURE IN WHICH MEDICAL DEVICES/PRODUCTS ARE INSERTED INTO THE PATIENTS VASCULATURE AND MANIPULATED TO VARYING DEGREES AND IS LISTED IN THE IFU AS SUCH. MYOCARDIAL INFARCTION (MI) OR ACUTE MYOCARDIAL INFARCTION (AMI), COMMONLY KNOWN AS A HEART ATTACK IS THE INTERRUPTION OF BLOOD SUPPLY TO PART OF THE HEART, CAUSING SOME HEART CELLS TO DIE. THIS IS MOST COMMONLY DUE TO OCCLUSION (BLOCKAGE) OF A CORONARY ARTERY FOLLOWING THE RUPTURE OF A VULNERABLE ATHEROSCLEROTIC PLAQUE, WHICH IS AN UNSTABLE COLLECTION OF LIPIDS (FATTY ACIDS) AND WHITE BLOOD CELLS (ESPECIALLY MACROPHAGES) IN THE WALL OF AN ARTERY. THERE IS NO MEDICAL EVIDENCE TO SUGGEST A CAUSAL RELATIONSHIP BETWEEN THE STENT IMPLANTED IN THE CAROTID ARTERY AND THE REPORTED MI. THE INHERENT RISK OF THE PROCEDURE COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    AS IT WAS REPORTED BY THE (B)(4) DATA BASE, A PATIENT PRESENTED WITH A POST PROCEDURE NON-Q WAVE MYOCARDIAL INFARCTION TWO DAYS AFTER THE PROCEDURE, BEFORE BEING DISCHARGE FROM THE HOSPITAL. THE PATIENT WAS AT THE FACILITY FOR AN ANGIOGRAPHY PROCEDURE ((B)(6) 2012) WITH MEDICAL HISTORY OF STROKE (NHI SCALE SCORE OF 2), PAST-MEDICAL HISTORY OF CORONARY ARTERY DISEASE, HYPERTENSION AND BILATERAL ARTERY STENOSIS. THE PROCEDURE WAS PERFORMED TO TREAT A CONCENTRIC MILD TORTUOUS AND MODERATE CALCIFIED RIGHT INTERNAL CAROTID ARTERY OSTIUM WITH A 95% STENOSIS. THE DEVICE USED WAS A PRECISE PRO RX, WHICH WAS IMPLANTED WITHOUT ANY PROBLEMS. THE PATIENT STARTED PRESENTING RECURRENT ISCHEMIC PAIN. CARDIAC ENZYMES CAME BACK SHOWING ((B)(6) 2012): CK (UL: 397): 877 AND CKMB (UL: 5.1 UG/L): 14.0 UG/L AND THE ECG ((B)(6) 2012) SHOWED A NON-Q WAVE MI. THE PATIENT HAS BEEN TAKING CLOPIDOGREL AND ASPIRIN PRE, POST PROCEDURE, DISCHARGE ((B)(6) 2012) AND ON HEPARIN DURING THE PROCEDURE.

    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 15580906

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR