BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 623093 · Received July 25, 2005

    Report

    Report Number
    9616099-2005-01231
    Event Type
    Injury
    Date Received
    July 25, 2005
    Date of Event
    May 23, 2005
    Report Date
    July 25, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SIX (6) DAYS AFTER THE INDEX PROCEDURE, THE PT COMPLAINED OF CHEST PAIN. CORONARY ANGIOGRAPHY REVEALED THROMBUS PRESENT IN THE THREE PREVIOUSLY IMPLANTED CYPHER STENTS. THE SUB ACUTE THROMBOSIS (SAT) WAS TREATED WITH ASPIRATION OF THE THROMBUS, AND PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY (PTCA) WITH A 3.0/15 MM BALLOON AT 8 ATM FOR 20 SEC. THE PHYSICIAN'S COMMENT REGARDING THE PROBABLE CAUSE OF THE SAT WAS THAT THE STENTS IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) MIGHT HAVE BEEN UNDER-DILATED. THE INDEX PROCEDURE WAS AN ELECTIVE CASE. THE TARGET LESIONS WERE THE MID AND DISTAL RCA. THE TARGET LESIONS WERE REPORTED TO BE: DE NOVO, CONCENTRIC, NOT A BIFURCATION LESION, ABSENT OF PRE-EXISTING CLOT, NOT CALCIFIED, NOT TORTUOUS, 30 MM IN LENGTH, AND TYPE C. THE LESIONS WERE PREDILATED WITH A 2.5/20 MM BALLOON AT 6 ATM FOR 30 SEC. THREE (3) CYPHER STENTS WERE IMPLANTED IN OVERLAPPING FASHION. A CYPHER 3.0/18 MM STENT WAS DEPLOYED IN THE DISTAL RCA AT 14 ATM FOR 45 SEC. A SECOND (2ND) CYPHER 3.0/23MM STENT WAS DEPLOYED IN THE DISTAL RCA AT 14 ATM FOR 30 SEC. A THIRD (3RD) CYPHER 3.5/18 MM STENT WAS DEPLOYED IN THE MID RCA AT 14 ATM FOR 45 SEC. POST-DILATION WAS DONE WITH A 3.5/18 MM BALLOON AT 10 ATM FOR 30 SEC. IVUS WAS NOT DONE. THE FLOW PRE-PROCEDURE WAS TIMI 3 AND POST-PROCEDURE WAS TIMI 2. BECAUSE OF THE SLOW-FLOW MENTIONED, THE PHYSICIAN ADMINISTERED INTRACORONARY NICRONDIL AND COMPLETED THE PROCEDURE. THE RESIDUAL STENOSIS WAS 0%. AN ACT WAS NOT RECORDED. THE PHYSICIAN EXPERIENCED SOME DIFFICULTY DELIVERING THE STENTS DUE TO INSUFFICIENT BACK-UP PROVIDED BY THE AL1 GUIDING CATHETER. THE PHYSICIAN USED A DOUBLE-GUIDEWIRE TECHNIQUE TO SUCCESSFULLY DEPLOY THE STENTS. PRE, POST, AND INTRA-PROCEDURE MEDICATIONS WERE: ASPRIIN 200 MG/DAY, AND TICLID 200 MG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R