BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001496 · Received February 19, 2008

    Report

    Report Number
    9616099-2008-00380
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    May 9, 2007
    Report Date
    January 22, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS RECEIPT. ANOTHER COUNTRY MANUFACTURED CYPHER PRODUCT WAS/IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT.

    Description of Event or Problem · 1

    PER THE STUDY: THIS MALE WITH A HISTORY OF OBESITY, PREVIOUS PCI, HYPERTENSION, HYPERLIPIDEMIA, AND DIABETES (INSULIN DEPENDANT) WAS ADMITTED FOR CORONARY EVALUATION DUE TO ACUTE MI WITHIN TWO-HOURS OF ONSET OF SYMPTOMS. HE WAS CURRENTLY TAKING BETA-BLOCKERS AND CALCIUM CHANNEL BLOCKERS. ANGIOGRAPHY REVEALED A 15MM, SMOOTH, IRREGULAR, CONCENTRIC, B2-TYPE LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE VESSEL WAS 2.5MM IN DIAMETER AND THERE WAS TIMI III FLOW THROUGH THE VESSEL. PLAVIX, ASPIRIN AND HEPARIN WERE ADMINISTERED. THE LESION WAS PREDILATED WITH A 2.0X20MM BALLOON INFLATED TO 10 ATMS. A 2.5X18MM CYPHER STENT WAS DEPLOYED TO 10ATMS WITH SATISFACTORY RESULTS. THE STENT WAS NOT POST DILATED. CARDIAC ENZYMES GREATER THAN 24 HOURS POST PROCEDURE WERE ELEVATED (CK=2.3 TIMES ULN, CK-MB=1 TIMES ULN, AND TROPONIN = 2.2 TIMES ULN), WHICH IS CONSISTENT WITH PRE-PROCEDURAL MI. THE PT WAS DISCHARGED AFTER NINE DAYS HOSPITALIZATION WITH ORDERS FOR DAILY ADMINISTRATION OF PLAVIX, (6 MONTHS DURATION), ASPIRIN, STATINS, BETA-BLOCKERS, AND CALCIUM CHANNEL BLOCKERS. AT ONE MONTH FOLLOW-UP, THE PT DENIED ANGINA AND WAS COMPLIANT WITH ALL CARDIAC MEDICATIONS. AT SIX-MONTH FOLLOW-UP, THE PT COMPLAINED OF STABLE ANGINA AND WAS COMPLIANT WITH ALL CARDIAC MEDICATIONS. AT 12-MONTH FOLLOW-UP, THE PT HAD NO ANGINAL COMPLAINTS AND REMAINED COMPLIANT WITH ALL CARDIAC MEDICATIONS. THREE YEARS POST INDEX PROCEDURE, THE PT UNDERWENT RE-PCI. IT IS UNK IF THIS WAS TARGET VESSEL/TARGET LESION RELATED. NO ADD'L INFO IS AVAILABLE REGARDING THIS EVENT.

    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 I0104001

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention CALCIUM CHANNEL BLOCKERS| ASPIRIN| STATINS| BETA BLOCKERS