BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1040530 · Received May 9, 2008

    Report

    Report Number
    9616099-2008-01261
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    December 21, 2007
    Report Date
    April 17, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, DURING THE INDEX PROCEDURE, THERE WAS AN ACUTE TOTAL OCCLUSION OF THE THIRD MARGINAL AFTER DEPLOYMENT OF STENT 2.5 X 13 IN THE MID CIRCUMFLEX. DESPITE 3 ATTEMPTS, IT WAS NOT POSSIBLE TO RECANALISE THE 3RD OBTUSE MARGINAL (OM3). IT WAS DECIDED TO STOP ANY INTERVENTION TO RECUPERATE THE OM3 CONSIDERING THAT THIS BRANCH WAS IRRIGATING A VERY SMALL CARDIAC ARTERIAL AREA. THE PT HAD A NON-Q-WAVE MYOCARDIAL INFARCTION (MI) POST INDEX PROCEDURE WITH <2 CK, CK-MB 3 TIMES ABOVE THE UPPER NORMAL LIMITS AND TROPONIN GREATER THAN OR EQUAL TO FIVE TIMES ABOVE THE UPPER NORMAL LIMITS. THE LOCATION WAS UNDETERMINED BUT IT WAS CONSIDERED TARGET VESSEL RELATED. THIS MI (ECG CHANGES, LATERAL WALL, NON Q WAVE CHANGES) WAS CONSECUTIVE TO ACUTE OCCLUSION OF SMALL OM3 BRANCH. THIS PT PRESENTED TO THE CARDIAC CATHERIZATION UNIT AND 1-VESSEL DISEASE WAS FOUND. THE PRIMARY INDICATION FOR INTERVENTION WAS STABLE ANGINA PECTORIS. PRE-PROCEDURE CK,CK-MB AND TROPONIN WERE LESS THAN TWO TIMES ABOVE THE UPPER NORMAL LIMITS. PRE-PROCEDURE MEDICATIONS INCLUDED ACE INHIBITORS. INTRA-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL AND INTEGRILIN. PCI WAS PERFORMED ON A 95% DE NOVO LESION IN THE MID CIRCUMFLEX OF 9MM IN LENGTH IN A 2.5MM VESSEL DIAMETER WITH MODERATE TORTUOSITY OF THE PROXIMAL SEGMENT. THE (TYPE C) ECCENTRIC LESION WAS CHARACTERIZED WITH AN IRREGULAR CONTOUR, LITTLE TO NO CALCIFICATION AND THROMBUS ABSENT. THE LESION WAS PRE-DILATED WITH A 2.0X8MM BALLOON AT 14 ATMOSPHERES (ATM) BEFORE A 2.5X13MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 14 ATM WITH SUB-OPTIMAL RESULTS. POST-DILATATION WAS CONDUCTED WITH A 2.5X10MM BALLOON AT 15 ATM BECAUSE THE STENT WAS NOT FULLY EXPANDED. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. PRE AND POST-PROCEDURE THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) WERE NOT DOCUMENTED. PCI WAS PERFORMED NEXT ON A 60% DE NOVO LESION IN THE PROXIMAL CIRCUMFLEX OF 22MM IN LENGTH IN A 2.5MM VESSEL DIAMETER. THE (TYPE C) ECCENTRIC LESION WAS CHARACTERIZED.

    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 13292538

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R POST PROCEDURE:| ASPIRIN| CLOPIDOGREL| BETA-BLOCKERS| ACE INHIBITORS| STATINS| CLOPIDOGREL| ASPIRIN| INTEGRILLIN| ACE INHIBITORS| INTRA-PROCEDURE:| DEVICES: GUIDANT WHISPER WIRE| MEDICATIONS: PRE-PROCEDURE: