BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1071597 · Received July 8, 2008

    Report

    Report Number
    3003742446-2008-00124
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    September 5, 2007
    Report Date
    June 13, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO PRODUCTS WITH THE SAME CATALOG AND LOT NUMBERS ARE REPRESENTED. THE PRODUCT WAS NOT AVAILABLE FOR ANALYSIS. THE STERILE LOT NUMBERS ARE UNK THEREFORE A DEVICE HISTORY REVIEW REPORT COULD NOT BE PERFORMED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY STENTS. WITH THE VERY LIMITED AVAILABLE INFO IT IS NOT POSSIBLE TO DETERMINE EXACTLY WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    DURING AN INTERNAL REVIEW OF COMPLAINT FILES, IT WAS NOTED THAT THE SIZE OF THE STENT (3 X 33MM) WAS PROVIDED. HOWEVER, THERE IS NO WAY TO DETERMINE WHAT TYPE OF CYPHER THEY ARE REFERRING TO.

    Description of Event or Problem · 1

    THE PT WAS HOSPITALIZED FOR A RESTENOSIS INTRA-CYPHER IN THE TARGET LESION IN 2007 (INCLUSION OF THE PT IN THE STUDY). THERE IS NO INFO ON WHICH OF THE 2 CYPHER IMPLANTED AT INITIAL PROCEDURE RESTENOSED. THE LESION LENGTH WAS 18MM AND DIAMETER STENOSIS WAS 83%. THE LESION (SAME DAY) WAS IRREGULAR, CONCENTRIC, READILY ACCESSIBLE, WITH NO ANGULATION AND NO CALCIFICATION. THERE WAS NO BIFURCATION OR SIDE BRANCH INVOLVED. THIS LESION WAS TREATED WITH A BALLOON ONLY, BRAND UNK, 20 X 3.50, MAX. INFLATION PRESSURE 22 ATM. RESULT WAS SATISFYING. PT CAME BACK FOR HIS 9 MONTH FOLLOW-UP CORONAROGRAPHY IN 2008, WITH CHEST PAIN. THE EXAM SHOWED RESTENOSIS OF THE TARGET LESION. IT WAS TREATED BY IMPLANTATION OF A CYPHER STENT (NO DETAILS AVAILABLE FOR NOW ON THIS STENT). PT LEFT THE HOSPITAL ON THE NEXT DAY. INITIAL STENT IMPLANTATION IN THE TARGET LESION OCCURRED IN 2004. INDICATION FOR THE PROCEDURE WAS Q-WAVE MI. THE TARGET LESION WAS THE MID RIGHT CORONARY ARTERY. THE LESION WAS 3.09 MM IN DIAMETER AND 30 MM IN LENGTH. THERE WAS NO BIFURCATION, LESION CONTOUR WAS SMOOTH, NO TORTUOSITY, NO ANGULATION, ECCENTRIC, AND NO CALCIFICATION. TWO CYPHER STENTS WERE DEPLOYED AT 16 ATM, IN THE MID RIGHT CORONARY ARTERY (BOTH STENTS WERE 33 MM X 3.00MM; NEITHER CATALOG NUMBER NOR LOT NUMBER AVAILABLE AT THAT POINT).

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention MEDICATIONS: CLOPIDOGREL| TRIATEC| HEPARIN| ISOPTIN| KARDEGIC| RISORDAN| SECTRAL| TAHOR| XYLOCAINE