BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2974694 · Received February 22, 2013

    Report

    Report Number
    3003742446-2013-00043
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    February 11, 2013
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED LIPITOR, METOPROLOL, PLAVIX, AND SIMVASTATIN. PLEASE NOTE THAT THE ACTUAL EVENT DATE IS UNKNOWN HOWEVER IT WAS REPORTED THAT THE PATIENT HAD A HEART ATTACK IN 2007. THE REPORT RECEIVED FROM THE MEDICAL AFFAIRS INDICATED THAT A PATIENT EXPERIENCED HEART ATTACK APPROXIMATELY 3 YEARS POST INITIAL CYPHER STENT PLACEMENT. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ALLERGIES: MORPHINE, TYLENOL, SEASONAL; CAD, PTSD, DENIES SMOKING AND ALCOHOL USE, FORMER DRUG ABUSE. ON (B)(6) 2004, THE PATIENT HAD A CYPHER STENT PLACED IN AN UNKNOWN ARTERY DUE TO HEART ATTACK. IN 2007, THE PATIENT EXPERIENCED CHEST PAIN AND WAS DIAGNOSED WITH A HEART ATTACK. AS TREATMENT, THE PATIENT UNDERWENT PLACEMENT OF TWO UNKNOWN CORONARY STENTS IN UNKNOWN ARTERIES. PLAVIX THERAPY WAS RESUMED. NO ADDITIONAL INFORMATION IS AVAILABLE TO DATE. THE STUDY STENT REMAIN IMPLANTED THUS UNAVAILABLE 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. REVIEW OF LOT 40104479 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MYOCARDIAL INFARCTION (HEART ATTACK) AND RESTENOSIS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, WHICH LEADS TO DAMAGED HEART CELLS AND THE RELEASE OF CARDIAC BIOMARKER ENZYMES INTO THE SYSTEMIC BLOODSTREAM. THIS ACTION (INHERENT RISK OF THE PROCEDURE) MAY HAVE CONTRIBUTED TO THE EVENT OF MI. THE ACT OF CORONARY STENTING IN AN OSTIAL LESION IS ASSOCIATED WITH A LOW SUCCESS RATE, HIGH RATE OF COMPLICATIONS AND A HIGH INCIDENCE OF TARGET VESSEL REVASCULARIZATION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT ASIDE FROM THE INHERENT RISK OF THE PROCEDURE THAT, VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NOTHING TO INDICATE THAT THESE EVENTS ARE RELATED TO THE DESIGN OR MANUFACTURING PROCESS THEREFORE NO ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE MEDICAL AFFAIRS INDICATED THAT A PATIENT EXPERIENCED HEART ATTACK APPROXIMATELY 3 YEARS POST INITIAL CYPHER STENT PLACEMENT. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ALLERGIES: MORPHINE, TYLENOL, SEASONAL; CAD, PTSD, DENIES SMOKING AND ALCOHOL USE, FORMER DRUG ABUSE. ON (B)(6) 2004, THE PATIENT HAD A CYPHER STENT PLACED IN AN UNKNOWN ARTERY DUE TO HEART ATTACK. IN 2007, THE PATIENT EXPERIENCED CHEST PAIN AND WAS DIAGNOSED WITH A HEART ATTACK. AS TREATMENT, THE PATIENT UNDERWENT PLACEMENT OF TWO UNKNOWN CORONARY STENTS IN UNKNOWN ARTERIES. PLAVIX THERAPY WAS RESUMED. NO ADDITIONAL INFORMATION IS AVAILABLE TO DATE. THE STUDY STENT REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78558 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 40104479

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R