BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021049 · Received March 26, 2008

    Report

    Report Number
    9616099-2008-00738
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    August 31, 2004
    Report Date
    July 4, 2006
    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

    THE PRODUCT(S) ARE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING ROUTE SHEETS FOR THE INVOLVED LOT(S) CONFIRMED THAT THE DEVICE(S) MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. CYPHER SELECT PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS MALE PATIENT WITH A HISTORY OF HYPERCHOLESTEROLEMIA, SMOKING, AND PREVIOUS MI NON-Q WAS ADMITTED FOR UNSTABLE ANGINA. HE WAS CURRENTLY TAKING ASA, CLOPIDOGREL, NITRATES, AND B-BLOCKERS. ANGIOGRAPHY REVEALED A CRITICAL STENOSIS WITHIN THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE DIAGONAL BRANCH. HEPARIN, ASPIRIN, IIB-IIIA INHIBITORS (PER INFUSION), AND NITRATE WERE ADMINISTERED DURING THE PROCEDURE. THE LAD WAS PRE-DILATED WITH A 2.5 X 10MM BALLOON INFLATED TO 10 ATMS. A 3.0 X 18MM CYPHER SELECT STENT WAS DEPLOYED TO 15 ATMS. THE STENT WAS POST-DILATED WITH A 3.5 X 9MM BALLOON INFLATED TO 12 ATMS. DURING STENT IMPLANTATION, THE DIAGONAL BRANCH BECAME OCCLUDED. THE EXACT DETAILS REGARDING THIS ARE UNKNOWN. THE DIAGONAL BRANCH WAS NOT TREATED AND REMAINED TOTALLY OCCLUDED AT THE END OF THE PROCEDURE. FLOW THROUGH THE LAD WAS TIMI III. POST PROCEDURE, CARDIAC ENZYMES WERE ELEVATED AND THE PATIENT WAS RULED IN FOR NON-Q WAVE MI, SECONDARY TO THE OCCLUDED DIAGONAL BRANCH. CK WAS ELEVATED > 3 TIMES ULN, CK-MB WAS ELEVATED > 2 TIMES ULN AND TROPONIN WAS ELEVATED > 5 TIMES ULN. NO ADDITIONAL ACTION WAS TAKEN. THE EVENT RESOLVED WITHIN 3 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 R0604002

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening 10X2.5 BALLOON| PLAVIX| NITRATE| HEPARIN| 9X3.5 BALLON| ASPIRIN