BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021278 · Received March 25, 2008

    Report

    Report Number
    9616099-2008-00769
    Event Type
    Injury
    Date Received
    March 25, 2008
    Report Date
    February 26, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYPHER SELECT PROD IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF THREE REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 9616099-2008-00767, -00768 AND -00769.

    Description of Event or Problem · 1

    THIS MALE PT WITH A HISTORY OF PREVIOUS PCI (NON-TARGET) HYPERLIPIDEMIA, SMOKING, AND A FAMILY HISTORY OF CAD WAS ADMITTED FOR CORONARY EVAL. HE WAS CURRENTLY TAKING ASPIRIN, PLAVIX, AND STATINS. THE MAIN INDICATION FOR THE EVAL WAS STABLE ANGINA. BASELINE LABS AND VITAL SIGNS REVEALED MILD CARDIOMYOPATHY (EJECTION FRACTION 30-50%). ANGIOGRAPHY REVEALED A 60% TO 85%, 36MM, DE NOVO IRREGULAR, ECCENTRIC, TYPE-C LESION EXTENDING FROM THE PROXIMAL THROUGH THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THIS LESION CROSSED THE BIFURCATION OF THE DIAGONAL BRANCH. HEPARIN AND REOPRO WERE ADMINISTERED. THE MID-LAD AND DIAGONAL WERE DOUBLE WIRED. THE MID-LAD (85% STENOSIS) WAS PRE-DILATED WITH A 2.0 X 20MM BALLOON INFLATED TO 18 ATMS. A 2.25 X 23MM CYPHER SELECT PLUS STENT WAS DEPLOYED TO 18 ATMS WITH SATISFACTORY RESULTS. THEN A 2.25 X 13MM CYPHER SELECT PLUS WAS DEPLOYED TO 20 ATMS WITH SATISFACTORY RESULTS. FOLLOWING DEPLOYMENT OF THE SECOND STENT THE LESION BECAME OCCLUDED DISTALLY. THIS WAS TREATED WITH REOPRO INFUSION, NITROPRUSSIDE, AND NITROGLYCERINE INTRACORONARY. THE PROXIMAL LAD WAS NOT PRE-DILATED (60% STENOSIS). A 3.5X13 MM CYPHER SELECT STENT WAS PLACED VIA DIRECT STENTING TECHNIQUE AND WAS DEPLOYED TO 14 ATMS WITH SATISFACTORY RESULTS. THE STENTS WERE NOT POST-DILATED. POST PROCEDURE THE PT EXPERIENCED CHEST PAIN. CARDIAC ENZYMES WERE ELEVATED > 5 TIMES (PEAK) THE ULN (CK, CK-MB AND TROPONIN). THE PT WAS RULED IN FOR A LATER WALL MI. THERE WAS NO EVIDENCE OF THROMBOSIS. THIS REQUIRED A PROLONGED HOSPITALIZATION, BUT NO ADD'L ACTION WAS TAKEN. THE EVENT RESOLVED WITHOUT SEQUELAE AND THE PT WAS DISCHARGED AFTER FIVE DAYS.

    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 13337110

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L 2.0 X 20 MM BALLOON| 0.014" PTCA WIRES X2| 2.25 X 23 MM CYPHER SELECT PLUS| 2.25 X 13 MM CYPHER SELECT PLUS