BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1140384 · Received August 28, 2008

    Report

    Report Number
    9616099-2008-02108
    Event Type
    Death
    Date Received
    August 28, 2008
    Date of Event
    September 26, 2007
    Report Date
    August 4, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYPHER SELECT PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT. THIS IS ONE OF FIVE REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #'S 9616099-2008-02105, 9616099-2008-02106, 9616099-2008-02107, 9616099-2008-02108 AND 9616099-2008-02109.

    Description of Event or Problem · 1

    THIS PT WAS ADMITTED FOR CORONARY EVALUATION DUE TO STABLE ANGINA IN THE SETTING OF KNOWN 3-VESSEL DISEASE. OF NOTE THE PT ALSO HAS KNOWN CEREBROVASCULAR AND ENDOVASCULAR DISEASE. ANGIOGRAPHY SHOWED A 90MM, HEAVILY CALCIFIED, TORTUOUS CTO EXTENDING FROM THE PROXIMAL THROUGH THE DISTAL RCA. THE LESION WAS TREATED WITH THE IMPLANTATION OF 5 CYPHER SELECT PLUS STENT: 2.5 X 33MM DEPLOYED TO 30 ATMS, 3.0 X 33MM DEPLOYED TO 30 ATMS, 3.0 X 33MM DEPLOYED TO 18 ATMS, 3.0 X 33MM DEPLOYED TO 22 ATMS, AND A 3.0 X 23MM DEPLOYED TO 24 ATMS. FOLLOWING STENT IMPLANTATIONS, INSUFFICIENT FLOW WAS NOTED AND THE STENTS WERE ALL POST DILATED WITH A 2.0 X 15MM BALLOON INFLATED TO 20 ATMS. SATISFACTORY RESULTS WERE ACHIEVED AND THE PT WAS DISCHARGED THE FOLLOWING DAY. APPROX NINE MONTHS POST PROCEDURE, THE PT PRESENTED WITH A NON Q-WAVE MI. THE PT WAS DIAGNOSED WITH ACUTE CORONARY SYNDROME WITH NO DYNAMIC ECG CHANGES EXCEPT OLD LEFT BUNDLE BRANCH BLOCK. THERE WAS NO SIGNIFICANT ENZYME RISE BUT CONTINUED TO EXPERIENCE CHEST DISCOMFORT. DUE TO PAST MEDICAL HISTORY IT WAS DECIDED TO PERFORM PCI. THE PT WAS TAKEN FOR ANGIOGRAPHY FIVE DAYS LATER, WHICH REVEALED THAT THE FIVE PREVIOUSLY IMPLANTED CYPHER STENTS IN THE RCA SHOWED NO EVIDENCE OF IN-STENT OR PERI-STENT RESTENOSIS, THROMBOSIS, OR ANEURYSM. AN ADD'L 100% LESION WAS NOTED IN THE FIRST OBTUSE MARGINAL BRANCH (OM1). THIS WAS TREATED WITH THE PLACEMENT OF A NON-CORDIS STENT. FOLLOWING THE PROCEDURE, THE PT REQUIRED SURGICAL REPAIR OF THE RIGHT EXTERNAL ILIAC ARTERY DUE TO LACERATION. THE DETAILS OF THIS EVENT ARE NOT AVAILABLE; HOWEVER, IT IS REPORTED THAT A CORDIS SHEATH WAS USED TO ACCESS THE ARTERY. APPROX 18 DAYS LATER (ONE-YEAR POST INDEX PROCEDURE) THE PT PRESENTED VIA AMBULANCE IN FULL CARDIAC ARREST. HE WAS FOUND TO BE IN VENTRICULAR FIBRILLATION (VF). THE PT WAS SUCCESSFULLY RESUSCITATED AT THAT TIME; HOWEVER, FURTHER VF ARRESTS OCCURRED AND RESUSCITATION WAS UNSUCCESSFUL. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    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 13258504

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| L| R 1.25 X 15 MM BALLOON| ADD'L CYPHER STENTS| ASPIRIN| PLAVIX| HEPARIN