BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1212601 · Received October 24, 2008

    Report

    Report Number
    9616099-2008-02521
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    July 10, 2008
    Report Date
    September 29, 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
    IT
    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 TWO REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #: 9616099-2008-02518. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS MALE PATIENT WITH A HISTORY OF PREVIOUS MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION WITH AN ARTHOS STENT (EARLY 2008), HYPERTENSION, HYPERLIPIDEMIA, SMOKING, AND COPD WAS ADMITTED FOR ANGIOGRAPHIC CORONARY EVALUATION DUE TO UNSTABLE ANGINA. HE WAS CURRENTLY TAKING ASPIRIN, PLAVIX, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. HEPARIN AND INTEGRILIN WERE ADMINISTERED DURING THE PROCEDURE. ANGIOGRAPHY REVEALED A 70%, IN-STENT RESTENOSIS OF THE ARTHOS STENT IN THE BIFURCATION OF THE UNPROTECTED LEFT MAIN ARTERY (LMA), THE LAD AND THE LCX. THE LESION WAS IRREGULAR AND ECCENTRIC WITH MODERATE CALCIFICATION. THE VESSEL WAS DESCRIBED AS 3.0MM IN DIAMETER WITH EXCESSIVE TORTUOSITY. SPECIFICALLY THE LESION WAS LOCATED IN AN ACUTE BEND >90 DEGREES. THE TARGET SITE WAS PREDILATED WITH A 2.5 X 15MM BALLOON INFLATED TO 14 ATMS. A 3.0 X 23MM CYPHER SELECT PLUS STENT WAS DEPLOYED TO 14 ATMS. THE STENT WAS POST DILATED WITH A 3.0 X 20MM BALLOON INFLATED TO 16 ATMS TO ENSURE COMPLETE EXPANSION. A 2.5 X 13MM CYPHER SELECT STENT WAS THEN PLACED VIA THE CRUSH TECHNIQUE AND WAS DEPLOYED TO 14 ATMS WITH GOOD RESULTS. THE STENT WAS NOT POST DILATED. RESIDUAL STENOSIS WAS 0%. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT WAS DISCHARGED AFTER 6 DAYS HOSPITALIZATION. APPROXIMATELY THREE MONTHS LATER, THE PATIENT PRESENTED WITH STABLE AND AN ANGIOGRAM WAS PERFORMED. THERE WAS NO EVIDENCE FOR MI OR THROMBOSIS. ANGIOGRAPHY REVEALED A 70% RESTENOSIS WITHIN THE CYPHER STENTS IMPLANTED IN THE LMA/LAD/CX. THE PATIENT WAS STRATIFIED TO CORONARY BYPASS SURGERY (CABG). ONE MONTH LATER, THE PATIENT UNDERWENT CABG AND RECEIVED THREE BYPASS GRAFTS: AN IMA TO THE LAD, AND SVGS TO THE OM AND THE RCA.

    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 13307564

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R ACE INHIBITORS| BETA-BLOCKERS| STATINS| PLAVIX| ASPIRIN