BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1004012 · Received February 26, 2008

    Report

    Report Number
    9616099-2008-00463
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 2, 2007
    Report Date
    February 7, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS ADMITTED TO HOSP IN 2004, BECAUSE OF CHEST OPPRESSION AFTER A SUB ACUTE ANTERIOR MYOCARDIAL INFARCTION. A CORONARY ANGIOGRAM SHOWED TOTAL OCCLUSIONS OF BOTH THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND PROXIMAL RIGHT CORONARY ARTERY (RCA). IN A SUBSEQUENT PROCEDURE, A 3.0 X 28 MM SIROLIMUS-ELUTING CYPHER SELECT STENT WAS IMPLANTED IN THE LAD WITH A PRESSURE OF 14 ATM AFTER PREDILATATION AND AN ACCURA 4.0 X 23 MM BARE METAL STENT IN THE RCA. INTRAVASCULAR ULTRASOUND (IVUS) IMAGING SHOWED COMPLETE APPOSITION OF THE STENT STRUTS AGAINST THE VESSEL WALL OVER THE ENTIRE LENGTH OF THE STENT IN THE LAD. NINE MONTHS LATER, REPEATED CORONARY ANGIOGRAPHY BY SCHEDULED FOLLOW-UP SHOWED A "ZIG-ZAG" PHENOMENON AND IVUS EXAMINATION DEMONSTRATED LSM OF THE SIROLIMUS-ELUTING STENT IN THE LAD, WHILE THE BMS IN THE RCA WAS PATENT WITHOUT SIGNIFICANT RESTENOSIS OR STENT MALPOSITION. THE PT REMAINED ASYMPTOMATIC AT THE SUBSEQUENT CLINICAL FOLLOW-UP AND WAS SWITCHED FROM COMBINED ANTIPLATELET TREATMENT WITH ASPIRIN AND CLOPIDOGREL TO ASPIRIN ALONE 23 MONTHS AFTER STENTING. HOWEVER, 29 MONTHS AFTER STENTING AND 20 MONTHS AFTER IDENTIFICATION OF LSM, THE PT RETURNED TO THE EMERGENCY ROOM AND COMPLAINED OF ABRUPT CHEST PAIN. A NEW ONSET OF ST-SEGMENT ELEVATION AND PATHOLOGIC Q-WAVE WAS NOTED AT THE PRECORDIAL LEADS ON ECG, AND CARDIAC ENZYMES WERE ALSO MARKEDLY ELEVATED. HE WAS DIAGNOSED WITH AN ANTERIOR MYOCARDIAL REINFARCTION AND EMERGENCY CORONARY ANGIOGRAPHY SHOWED ST AT THE STENTED SEGMENT AND A TOTAL OCCLUSION OF THE LAD, WHILE THE BMS IMPLANTED THE RCA WAS VERY PATENT. SUBSEQUENTLY, THE PT RECEIVED SUCCESSFUL PRIMARY INTERVENTION WITH THROMBUS ASPIRATION AND BALLOON ANGIOPLASTY (FENG, JUYING, JUNBO ET AL, 2007). THE LOT NUMBER IS UNAVAILABLE, THEREFORE, A DEVICE HISTORY REPORT COULD NOT BE PERFORMED. THROMBOSIS AND MYOCARDIAL INFARCTION ARE BOTH A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. REVIEW OF THE LIMITED INFO SUGGEST THAT PT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATED PRODUCT. ANY ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS IS AN INITIAL AND FINAL REPORT: AN ARTICLE WAS RECEIVED REGARDING A PT THAT EXPERIENCED VERY LATE STENT THROMBOSIS AND LATE STENT MALPOSITION AFTER HAVING A DRUG ELUTING CORONARY STENT IMPLANTED. NINE MONTHS POST CYPHER STENT IMPLANT, A REPEAT CORONARY ANGIOGRAM WITH INTRAVASCULAR ULTRASOUND SHOWED LATE STENT MALPOSITION IN THE CYPHER STENT, THERE IS NO MENTION IF ANY INTERVENTION WAS PERFORMED AT THE TIME. TWENTY-NINE MONTHS AFTER THE INDEX PROCEDURE, THE PT PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF CHEST PAIN. A Q WAVE MI WAS DIAGNOSED FROM AN ECG AND THE PT HAD REPEAT CAG SHOWING THROMBUS AND TOTAL OCCLUSION. THE EVENT WAS TREATED WITH ASPIRATION AND PLAIN OLD BALLOON ANGIOPLASTY. REFERENCE: FENG MD, ZHANG, JUYING MD, QIAN, AND JUMBO MD, GE (2007). VERY LATE STENT THROMBOSIS IN LATE STENT MALPOSITION. JOURNAL OF INTERNATION HEART, 48, 591-596.

    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 32 YR Hospitalization| L| R ACCURA 4.0 X 23MM