BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1003564 · Received February 25, 2008

    Report

    Report Number
    9616099-2008-00452
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    January 19, 2008
    Report Date
    January 30, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 9616099-2008-00450. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE STUDY. THE REPORT INDICATES THAT POST-PROCEDURE THE PATIENT HAD ELEVATED TROPONIN AND A NON Q-WAVE LATERAL MYOCARDIAL INFARCTION. THROMBOSIS WAS CONFIRMED BY ANGIOGRAPHY. THE PATIENT IS A 52 YEAR OLD FEMALE WITH 3-VESSEL DISEASE. THE INDICATION FOR THE INDEX PROCEDURE WAS AN ACUTE MYOCARDIAL INFARCTION (AMI), WITH PAIN ONSET BETWEEN 12 HOURS AND 24 HOURS PRIOR TO THE PROCEDURE. THE AMI WAS AN NSTEMI IN AN UNDETERMINED LOCATION. NO THROMBOLYTIC AGENT WAS GIVEN AND THERE WERE NO NEW Q-WAVES. HEART RATE AT BASELINE WAS 70/MIN. BLOOD PRESSURE WAS 125/65 AND LVEF WAS 30-50%. CARDIAC ENZYMES WERE NORMAL PRE-PROCEDURE. THE FIRST TARGET VESSEL WAS THE MID RIGHT CORONARY ARTERY (RCA). THE VESSEL DIAMETER WAS 3MM AND THE LESION LENGTH WAS 50MM. PRE-PROCEDURE STENOSIS WAS 99% AND TIMI FLOW WAS 2. THE LESION WAS DE NOVO, WITH IRREGULAR CONTOUR, MODERATE TORTUOSITY AND CALCIFICATION. THE LESION WAS PRE-DILATED WITH A 2.5 X 18MM BALLOON AT 14 ATM. TWO STENTS WERE IMPLANTED, ABUTTING, IN THE LESION. TWO CYPHERS WERE DEPLOYED AT 16ATM AND THERE WAS NO POST-DILATION. POST-PROCEDURE STENOSIS WAS 0% AND TIMI FLOW WAS 3. THE 2ND TARGET VESSEL WAS THE MID CIRCUMFLEX ARTERY (CFX). VESSEL DIAMETER WAS 3MM AND THE LESION LENGTH WAS 10MM. PRE-PROCEDURE STENOSIS WAS 50% AND TIMI FLOW WAS 3. THE LESION WAS DE NOVO AND MODERATELY CALCIFIED. THE LESION WAS NOT PRE-DILATED. THIRD CYPHER WAS DEPLOYED AT 16ATM. POST-PROCEDURE STENOSIS WAS 0% AND TIMI FLOW WAS 3. THE 3RD TARGET VESSEL WAS ONE OF THE OTHER OBTUSE MARGINAL (OM) SEGMENTS. VESSEL DIAMETER WAS 2.25MM AND THE LESION LENGTH WAS 10MM. PRE-PROCEDURE STENOSIS WAS 99% AND TIMI FLOW WAS 3. THE LESION WAS DE NOVO, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED. THE LESION WAS PRE-DILATED WITH A 2 X 15MM BALLOON AT 10ATM. FOURTH CYPHER WAS DEPLOYED AT 12ATM. POST-PROCEDURE STENOSIS WAS 0% AND TIMI FLOW WAS 3. POST-PROCEDURE, TROPONIN WAS ELEVATED 2 TIMES ABOVE UPPER NORMAL LEVEL (UNL). THE PATIENT WAS DISCHARGED 2 DAYS LATER. MEDICATIONS AT DISCHARGE WERE ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS, AND BETA BLOCKERS. THE DAY AFTER DISCHARGE THE PATIENT WAS REHOSPITALIZED BECAUSE OF ANGINA PECTORIS, INCREASE IN CARDIAC ENZYMES, AND ST-ELEVATION. THE PATIENT WAS DIAGNOSED WITH A LATERAL NON Q-WAVE LATERAL MYOCARDIAL INFARCTION. PEAK CK WAS 4 TIMES ABOVE UNL AND TROPONIN WAS GREATER THAN 5 TIMES UNL. CORONARY ANGIOGRAPHY CONFIRMED STENT THROMBOSIS IN THE 2ND CYPHER (CFX) AND THE 3RD CYPHER (OTHER OM). THERE WAS TIMI FLOW OF 0 AND A100% TOTAL OCCLUSION OF THE STENTS. THERE WAS A TIMI FLOW OF 3 AND NO IN-STENT RESTENOSIS OF THE STENTS IN THE MID RCA. IT WAS IMPOSSIBLE TO PLACE A GUIDEWIRE IN THE 3RD VESSEL (OTHER OM) AND THE 2ND VESSEL (CFX) WAS TREATED WITH BALLOON DILATION ONLY. THE EVENT RESOLVED WITHOUT SEQUEL.

    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 13289247

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R HEPARIN| ASPIRIN| STATINS| BETA BLOCKERS| CLOPIDOGREL