BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001525 · Received February 20, 2008

    Report

    Report Number
    9616099-2008-00401
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    November 13, 2007
    Report Date
    January 31, 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

    PCI WAS PERFORMED ON A 98% DE NOVO LESION IN A SAPHENOUS VEIN GRAFT NEAR THE DISTAL RIGHT CORONARY ARTERY. THE (TYPE C) CONCENTRIC LESION WAS CHARACTERIZED WITH OCCLUSION GREATER THAN 3 MONTHS, MODERATE CALCIFICATION AND THROMBUS ABSENT. THE LESION WAS PRE-DILATED WITH A 3.0X28MM BALLOON AT 20 ATMOSPHERES (ATM) BEFORE 3 OVERLAPPING STENTS WERE DEPLOYED. A 2.5X18MM CYPHER SELECT STENT WAS DEPLOYED AT 14 ATM WITH SATISFYING RESULTS. THERE WAS NO POST-DILATATION. THEN A 2.75X23MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 18 ATM WITH SATISFYING RESULTS. FINALLY, A 3.0X28MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 20 ATM WITH SATISFYING RESULTS. POST-DILATATION WAS DONE BECAUSE THE STENT WAS NOT FULLY EXPANDED AND DUE TO INSUFFICIENT FLOW. PRE AND POST-PROCEDURE THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) FLOWS WERE NOT DOCUMENTED. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED. POST-PROCEDURE TROPONIN WAS GREATER THAN OR EQUAL TO FIVE TIMES ABOVE THE UPPER NORMAL LIMITS AT THE 6-24 HOUR INTERVAL. DURING THE SAME INTERVAL, CK WAS NORMAL BUT CK-MB WAS NOT CHECKED. THE TROPONIN INCREASE WAS CLASSIFIED AS A NON Q-WAVE MYOCARDIAL INFARCTION WITH AN UNDETERMINED LOCATION. THERE WAS NO EVIDENCE OF STENT THROMBOSIS. THE PATIENT WAS ASYMPTOMATIC. NO TREATMENT WAS PROVIDED. THIS EVENT WAS CLASSIFIED AS UNRELATED TO THE CYPHER STENT. THE PATIENT WAS DISCHARGED ON THE FOLLOWING DAY. POST-PROCEDURE MEDICATIONS INCLUDED PERMANENT ASPIRIN, CLOPIDOGREL FOR 6 MONTHS, STATINS AND BETA-BLOCKERS. APPROXIMATELY 3 1/2 WEEKS LATER, TELEPHONE FOLLOW-UP WAS MADE WITH THE PATIENT WHO WAS ASYMPTOMATIC. ONGOING MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS AND BETA-BLOCKERS. THERE WERE NO ADVERSE EVENTS REPORTED. PLEASE NOTE THAT THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS ASSOCIATED WITH THE REPORTED EVENTS THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 9616099-2008-00400, 9616099-2008-00401 AND 9616099-2008-00402.

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, ONE DAY FOLLOWING PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PATIENT HAD A NON-Q-WAVE MYOCARDIAL INFARCTION (MI). THIS PATIENT PRESENTED TO THE CARDIAC CATHETERIZATION UNIT WITH STABLE ANGINA PECTORIS AS THE PRIMARY INDICATION FOR INTERVENTION AND 1-VESSEL DISEASE WAS FOUND. PRE-PROCEDURE TROPONIN CARDIAC ENZYMES WERE LESS THAN TWO TIMES ABOVE UPPER NORMAL LIMITS. THE PATIENT'S BLOOD PRESSURE WAS 111/68, LEFT VENTRICLE EJECTION FRACTION (LVEF) WAS >50% AND THE HEART RATE WAS 56. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS AND BETA-BLOCKERS. INTRA-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL AND UNFRACTIONATED HEPARIN.

    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 13290196

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L POST-ASPIRIN| BETA-BLOCKERS| STATINS| BALANCE GUIDEWIRE| CLOPIDOGREL| PRE-ASPIRIN| STATINS| BETA-BLOCKERS| DEVICES: 6F GUIDING CATHETER| CLOPIDOGREL| 3.0X28 BALLOON CATHETER| INTRA-ASPIRIN| UNFRACTIONATED HEPARIN.| CLOPIDOGREL