BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1161344 · Received September 12, 2008

    Report

    Report Number
    9616099-2008-02226
    Event Type
    Death
    Date Received
    September 12, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 21, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPORT RECEIVED FROM THE STUDY INDICATED THAT A PATIENT EXPERIENCED AN ACUTE MYOCARDIAL INFARCTION (AMI) AND DIED AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR PRIOR PERCUTANEOUS CORONARY INTERVENTION (PCI), HYPERTENSION, AND HYPERLIPIDEMIA. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DESCRIBED AS 90% STENOSED AND DE NOVO WITH A LENGTH OF 30MM. THE LESION WAS PRE-DILATED WITH A 2.0MM X 20MM BALLOON AT 12ATMS FOLLOWED BY THE DEPOLYMENT OF A 2.25MM X 23MM CYPHER SELECT STENT AT 14ATMS. A 2.75MM X 23MM CYPHER SELECT STENT WAS THEN DEPLOYED AT 16ATMS PROXIMAL AND OVERLAPPING THE FIRST STENT. THE STENTS WERE SATISFACTORILY DEPLOYED AND DID NOT REQUIRE POST-DILATION. APPROXIMATELY NINE MONTHS LATER THE PATIENT ARRIVED IN THE EMERGENCY ROOM WITH CHEST PAIN WHICH WAS DIAGNOSED AS ACUTE Q-WAVE MI OF UNDETERMINED LOCATION AND WITHIN TWO HOURS OF ARRIVAL, THE PATIENT SUFFERED A CARDIAC ARREST AND DIED. THE SITE REPORTED THAT THERE WAS NO EVIDENCE OF STENT THROMBOSIS. THE STERILE LOT NUMBER OF THE 2.25MM X 23MM CYPHER SELECT STENT IS UNKNOWN, THEREFORE, A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED ON THAT STENT. A DEVICE HISTORY REPORT REVIEW WAS CONDUCTED ON THE OTHER AND THIS LOT OF PRODUCTS MET THE REQUIREMENTS PER THE APPLICABLE QUALITY MANUFACTURING PLAN. MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND THE NATURAL PROGRESSION OF CORONARY ARTERY DISEASE. BASED ON THE LIMITED AMOUNT OF INFORMATION IT IS NOT POSSIBLE TO DETERMINE EXACTLY WHAT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBER IS 9616099-2008-02227.

    Description of Event or Problem · 1

    THIS PATIENT WAS ENROLLED IN THE STUDY IN 2007. THE MAIN INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. POST PROCEDURE THE PATIENT EXPERIENCED ELEVATED TROPONIN LEVELS. IN 2008, THE PATIENT WAS HOSPITALIZED FOR CHEST PAIN AND HAD SILENT ISCHEMIA. THE PATIENT PRESENTED WITH CHANGES IN THE EGC AND WAS DIAGNOSED WITH AN EXTENSIVE Q-WAVE MYOCARDIAL INFARCTION. THE MYOCARDIAL INFARCTION WAS IN AN UNDETERMINED LOCATION AND THERE WAS NO EVIDENCE FOR STENT THROMBOSIS. TWO HOURS LATER THE PATIENT SUFFERED A CARDIAC ARREST AND DIED. THE MEDICATION TREATMENT OF ASPIRIN, CLOPIDOGREL, ORAL ANTI-DIABETICS, STATINS AND BETA-BLOCKERS WAS ONGOING. THE TARGET LESION WAS A NATIVE, DE NOVO, NON-OSTIAL, IRREGULAR, READILY ACCESSIBLE, ECCENTRIC, TYPE C MID LEFT ANTERIOR DESCENDING. THE REFERENCE VESSEL DIAMETER WAS 2.75MM AND THE LESION LENGTH WAS 30MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 90%. THE LESION WAS PRE-DILATED WITH A 2.0 X 20MM BALLOON AT 12 ATM AND TWO CYPHER STENTS WERE IMPLANTED. THE FIRST STENT WA A 2.25 X 23MM CYPHER SELECT STENT, WHICH WAS ELECTIVELY IMPLANTED AT 14ATM WITH SATISFACTORY RESULTS. THE SECOND STENT WAS A 2.75 X 23 MM CYPHER SELECT STENT, WHICH WAS ELECTIVELY IMPLANTED AT 16 ATM WITH SATISFACTORY RESULTS. THE STENTS WERE NOT POST-DILATED. POST-PROCEDURE DIAMETER STENOSIS WAS 0%. THE PATIENT'S PRE-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, STATINS, ACE INHIBITORS, BETA-BLOCKERS AND CLOPIDOGREL. THE PATIENT'S INTRA-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, HEPARIN AND CLOPIDOGREL. THE PATIENT'S POST-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, ACE INHIBITORS, BETA-BLOCKERS AND CLOPIDOGREL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death PROCEDURE| A 6FR GUIDING CATHETER WAS USED DURING THE