BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1130912 · Received August 21, 2008

    Report

    Report Number
    9616099-2008-02048
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    April 2, 2008
    Report Date
    July 25, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDEX PROCEDURE WAS ELECTIVE. THE TYPE C TARGET LESION IN THE MID RCA WAS ECCENTRIC, 24.25 MM IN LENGTH, DIFFUSED AND BIFURCATED BUT NOT CALCIFIED. TIMI FLOW BEFORE AND AFTER THE INDEX PROCEDURE WAS 3. DURING THE INDEX PROCEDURE, A 52% STENOSIS IN THE DISTAL LEFT CIRCUMFLEX WITH A 3.0 X 23 MM CYPHER STENT IMPLANTED AT 12 ATM FOR 31-60 SECONDS. THE RESIDUAL STENOSIS WAS 0%. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. THE PHYSICIAN INDICATED THAT THE EVENT MIGHT BE RELATED TO THE CYPHER STENTS BECAUSE THE RESTENOSIS OCCURRED INSIDE OF THE STENTS. THE PROD IS NOT DISTRIBUTED IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNTIED STATES PROD. THE PROD IS NOT AVAILABLE FOR EVAL. THIS IS ONE OF THREE DEVICES IMPLANTED IN THE SAME PT AND REPORTED UNDER MFG REPORT NUMBERS: 9616099-2008-02046, 9616099-20008-02047 AND 9616099-2008-02048. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE REPORT WE REC'D FROM THE STUDY INDICATED THAT A FEMALE PT WAS ADMITTED FOR A 73% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED WITH A 2.0 X 15 MM BALLOON AT 8 ATM. DURING THE PRE-DILATION A DISSECTION OCCURRED WHICH WAS NOT TREATED AS STENTS WERE TO BE IMPLANTED. A 2.5 X 23 MM CYPHER STENT WAS IMPLANTED AT 12 ATM FOR 16-30 SECONDS. A 2ND CYPHER (3.0 X 18 MM: I0305105) WAS IMPLANTED AT THE PROXIMAL END OF THE INITIALLY IMPLANTED CYPHER. A 3RD CYPHER (3.0 X 18 MM: I0305040) WAS IMPLANTED AT THE PROXIMAL END OF THE 2ND CYPHER. ALL STENTS WERE OVERLAPPING. THE STENTS WERE POST-DILATED WITH A 2.0 X 15 MM BALLOON AT 10 ATM. THE RESIDUAL STENOSIS WAS 13%. ALMOST 3 YRS AFTER THE PROCEDURE, THE PT COMPLAINED OF CHEST PAIN. CORONARY ANGIOGRAPHY (CAG) WAS CONDUCTED AND RESTENOSIS WAS OBSERVED INSIDE OF THE CYPHER IMPLANTED IN THE MID RCA. IT WAS NOT KNOWN WHICH STENT RESTENOSED. TWO DAYS LATER, THE RESTENOSIS WAS TREATED WITH A 3.25 X 15 MM BALLOON AT 15 ATM. THE RESIDUAL STENOSIS WAS 0%. THE PT WAS DISCHARGED IN STABLE CONDITION AND WITHOUT CHEST PAIN.

    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 I0305028

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R CLOPIDOGREL SULFATE (50 MG/DAY)| ISOSORBIDE DINITRATE (6 MG/DAY)| ASPIRIN (250 MG/DAY)| HEPARIN (12000 U/DAY)| DILTIAZEM HYDROCHLORIDE (200 MG/DAY)| NITROGLYCER (40 MG/DAY)| TICLOPIDINE HYDROCHLORIDE (200 MG/DAY)| NITROGLYCERIN (0.6 MG/DAY)