BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1664530 · Received April 22, 2010

    Report

    Report Number
    3003742446-2010-00117
    Event Type
    Death
    Date Received
    April 22, 2010
    Date of Event
    February 24, 2007
    Report Date
    April 9, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 3003742446-2009-00077. THE STERILE LOT NUMBER FOR THE PRODUCTS IS UNKNOWN; THEREFORE, A DEVICE HISTORY REPORT REVIEW COULD NOT BE CONDUCTED.MYOCARDIAL INFARCTION, STENT THROMBOSIS AND DEATH ARE ALL KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND THE NATURAL PROGRESSION OF CORONARY ARTERY DISEASE. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT PHARMACOLOGICAL FACTORS (NO INDICATION OF THE PATIENT BEING ON ASPIRIN) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, BUT IT IS NOT POSSIBLE TO DETERMINE AN EXACT CAUSE FOR THE EVENT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT CARDIAC SURGERY ON (B) (6) 2004, DUE TO AN ACUTE MI. DURING THIS OPERATION, A CYPHER STENT WAS IMPLANTED IN THE PATIENT¿S LEFT CIRCUMFLEX ARTERY. THE LESIONS WERE NOT ¿DE NOVO, 15MM TO 30MM LONG AND IN ARTERIES THAT WERE 2.5-3.5MM WIDE. THE PATIENT SUFFERED AN MI SECONDARY TO IN-STENT THROMBOSIS AND SUBSEQUENTLY DIED ON (B) (6) 2007. ADDENDUM RECEIVED 4/9/2010: INDICATION FOR INITIAL STENT PLACEMENT WAS TYPICAL ANGINA SYMPTOMS AND CLAUDICATION. PRE-PROCEDURE STENOSIS WAS 95%. THE CIRCUMFLEX WAS PRE-DILATED WITH A 2 X 20MM BALLOON. A 3.5 X 28MM CYPHER AND A 3.5 X 18MM CYPHER WERE DEPLOYED IN THE PROXIMAL CIRCUMFLEX. BOTH STENTS WERE POST-DILATED TO 15 ATM. POST-PROCEDURE STENOSIS WAS 0%. PATIENT WAS DISCHARGED THE FOLLOWING DAY. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN ACUTE INFERIOR WALL MYOCARDIAL INFARCTION ON (B) (6) 2007. THE PATIENT HAD UNDERGONE VENTRICULAR FIBRILLATION ARREST AND UNDERWENT ACLS PROTOCOL FOR RESUSCITATION. THE PATIENT HAD PROLONGED DOWNTIME ESTIMATED BETWEEN 25 AND 25 MINUTES BETWEEN HIS EMS TRANSPORT AND ER RESUSCITATION. THE PATIENT WAS TAKEN TO THE CATHETERIZATION AND WAS FOUND TO HAVE A INSTENT THROMBOSIS OF CYPHERS (NUMBER OF STENTS UNKNOWN) IN THE LEFT CIRCUMFLEX ARTERY. THE PATIENT UNDERWENT BALLOON ANGIOPLASTY AND SINGLE STENT PLACEMENT (TAXUS 3.5 X 8). A BALLOON PUMP WAS INSERTED. THE PUMP WAS DISCONTINUED 48 HOURS AFTER INSERTION. THERE WAS NO SIGNIFICANT IMPROVEMENT IN HIS OVERALL NEUROLOGICAL STATUS, HE HAD SUFFERED SEVERE ANOXIC BRAIN INJURY. THE PATIENT¿S FAMILY WITH DREW LIFE SUPPORT AND THE PATIENT EXPIRED ON (B) (6) 2007.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death