BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2911620 · Received January 3, 2007

    Report

    Report Number
    9616099-2007-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2007
    Date of Event
    September 1, 2006
    Report Date
    November 1, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN SUMMARY, THE LAD WAS IN A DE NOVO, MODERATELY CALCIFIED, LONG (57.39MM), TORTUOUS, TYPE C LESION. THE LESION WAS PREDILATED AND TWO CYPHER SELECT STENTS (2.5 X 33MM AND A 2.75 X 33MM) WERE DEPLOYED TO 9 ATMS IN AN OVERLAPPING FASHION. THE STENT FRACTURE INVOLVED THE 2.75 X 33MM STENT ONLY. THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONALLY, THE STERILE LOT NUMBER IS NOT KNOWN. NO FURTHER ANALYSIS CAN BE PERFORMED FOR COMPLAINTS REPORTED WITHOUT A LOT NUMBER AND FOR WHICH THE ASSOCIATED PRODUCTS WILL NOT BE RETURNED. IN CONCLUSION, THE SAFETY AND EFFECTIVENESS OF PLACING A CYPHER SELECT STENT INTO A LESION THAT IS LONGER 30MM AND/OR TORTUOUS HAS NOT BEEN PROVEN. CONTRIBUTING FACTORS TO THIS STENT FRACTURE RELATE TO THE TREATMENT OF A LONG, COMPLEX LESION. PLEASE NOTE: CRA33275 IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US PRODUCT CXS33275.

    Description of Event or Problem · 1

    THIS COMPLAINT ORIGINATED FROM AN ABSTRACT PRESENTED IN (B)(6). THIS PATIENT WAS ADMITTED FOR CORONARY EVALUATION DUE TO STABLE ANGINA. ANGIOGRAPHY REVEALED A 95% , DE NOVO, MODERATELY CALCIFIED, LONG (57.39MM), TORTUOUS, C-TYPE LESION IN THE LAD. THE LESION WAS PREDILATED (DETAILS UNKNOWN). THE PATIENT DEPLOYED TWO CYPHER STENTS, A 2.5 X 33MM AND A 2.75 X 33MM, TO 9 ATMS WITHIN THE LAD. THE STENTS WERE OVERLAPPED. EIGHT MONTHS LATER, THE PATIENT RETURNED FOR ROUTINE FOLLOW-UP. ANGIOGRAPHY REVEALED A STENT FRACTURE IN THE STENTS AT THE OVERLAPPING SITE. PER ADDITIONAL INFO RECEIVED, NO RESTENOSIS WAS OBSERVED. THERE IS NO ADDITIONAL INFORMATION FORTHCOMING.

    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 50 YR