BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1020996 · Received March 26, 2008

    Report

    Report Number
    9616099-2008-00761
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    January 20, 2005
    Report Date
    April 7, 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 TARGET LESION FOR THE INDEX PROCEDURE WAS THE PROXIMAL LAD (MB) AND FIRST DIAGONAL (SB). THE LESION WAS A BIFURCATION LESION CLASSIFICATION SAFFIAN 1A. THE PROXIMAL LAD WAS PRE-DILATED WITH A 2.0 X 20MM BALLOON AT 14. THE FIRST DIAGONAL LESION WAS PRE-DILATED WITH A 2.0 X 20 MM BALLOON AT 10 ATM. NO OTHER LESION WAS TREATED DURING THIS PROCEDURE. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. A REPORT RECEIVED FROM THE STUDY INDICATED THAT THREE MONTHS AFTER THE INDEX PROCEDURE, THE PT BECAME UNSTABLE DURING THE FOLLOW-UP PERIOD AND WAS FOUND TO HAVE A 70% RESTENOSIS OF THE SIDE BRANCH/FIRST DIAGONAL LESION THAT WAS TREATED DURING THE INDEX PROCEDURE. THE RESTENOSIS WAS TREATED BY AN ADD'L BALLOON ANGIOPLASTY. THE PT IS A 77-YEAR OLD MALE WITH A MEDICAL HISTORY INCLUDES: PAST SMOKING, A FAMILY HISTORY OF ISCHEMIC HEART DISEASE, PREVIOUS NON-Q WAVE MYOCARDIAL INFARCTION (MI), AND STABLE ANGINA CLASS 3. THE PT'S AGE AND RISK FACTORS OF: PAST SMOKING AND PREVIOUS MI PUT HIM AT INCREASED RISK FOR MACE. DURING THE INDEX PROCEDURE, THE PT WAS REPORTED TO HAVE HAD A TYPE A DISTAL DISSECTION AND A PLAQUE SHIFT OF THE FIRST DIAGONAL/SIDE BRANCH LESION AFTER IMPLANTATION OF THE CYPHER SELECT 2.5 X 23 MM STENT. THE LESION WAS REPORTED TO BE A BIFURCATION LESION SAFFIAN CLASS 1A. THE DEVICE REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR INSPECTION. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. RESTENOSIS, CORONARY ARTERY DISSECTION AND PLAQUE SHIFT ARE KNOWN COMPLICATIONS OF CORONARY STENTING AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE ARE POSSIBLE PT, AND LESION FACTORS (BIFURCATION LESION) THAT MAY HAVE AFFECTED OR CONTRIBUTED TO THE EVENT. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE STUDY INDICATED THAT APPROXIMATELY THREE MONTHS AFTER THE INDEX PROCEDURE DURING THE FOLLOW-UP PERIOD, THE PT HAD UNSTABLE ANGINA AND WAS FOUND TO HAVE A 70% STENOSIS OF THE SIDE BRANCH (SB)/FIRST DIAGONAL LESION. THE RESTENOTIC LESION WAS TREATED BY BALLOON ANGIOPLASTY. A NEW LESION IN THE MID/DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS ALSO TREATED AT THIS TIME. THERE WAS NO REPORTED PROBLEM REPORTED WITH THE PREVIOUSLY IMPLANTED CYPHER SELECT STENT AT THIS TIME. THE INFO RECEIVED INDICATED THAT DURING THE INDEX PROCEDURE, THE PT HAD A TYPE A DISTAL DISSECTION OF THE SIDE BRANCH/FIRST DIAGONAL AFTER IMPLANTATION OF THE CYPHER SELECT 2.5 X 23 MM (STUDY) STENT AND ALSO A PLAQUE SHIFT. THE DISSECTION WAS TREATED BY IMPLANTATION OF A DRIVER 2.25 X 24 MM STENT AT 6 ATM. THE STENT WAS POST-DILATED USING A KISSING BALLOON TECHNIQUE WITH A 2.0 X 20 MM BALLOON AT 12 AND A 2.5 X 20MM BALLOON AT 7 ATM OF PRESSURE. THE RESIDUAL STENOSIS OF THE SIDE BRANCH (SB)/FIRST DIAGONAL WAS 10%, AND THE MAIN BRANCH (MB)/PROXIMAL LAD WAS 0%. THE FLOW POST-PROCEDURE WAS TIMI 3. THE PT WAS REPORTED TO HAVE RECOVERED.

    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 R1104002

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R 2.0 X 20 MM BALLOON| 2.5 X 20 MM BALLOON