BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1931607 · Received December 17, 2010

    Report

    Report Number
    9616099-2010-00982
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    November 22, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011. THE STENT FRACTURE INVOLVED ONLY ONE OF THE TWO STENTS THAT WERE IMPLANTED, THEREFORE, THIS REPORT IS NO LONGER A REPORTABLE EVENT SINCE THERE IS NO REPORTABLE MALFUNCTION ASSOCIATED WITH THIS DEVICE (THE OTHER DEVICE ASSOCIATED WITH THIS COMPLAINT REMAINS REPORTABLE). (B)(6) CYPHER PRODUCT ((B)(6)) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). THIS IS ONE OF TWO REPORTS SUBMITTED FOR THE SAME EVENT (NOT THREE AS PREVIOUSLY REPORTED). PLEASE REFERENCE MFR REPORT #S: 9616099-2010-00982 AND 9616099-2010-00981 (CORRECTED INFORMATION)

    Additional Manufacturer Narrative · 1

    OCTOBER 16, 2010. YASUSHI INO, MD., ET AL. SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION. AMERICAN HEART JOURNAL 2010;160:775.E1-775.E9. PLEASE NOTE THAT THE ACTUAL EVENT DATE FOR THIS EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). THIS IS ONE OF THREE REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 9616099-2010-00983, 9616099-2010-00984, AND 9616099-2010-00985.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM LITERATURE. AMERICAN HEART JOURNAL 2010;160:775.E1-775.E9 "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION." THIS CASE IS 24TH OF 29 EVENTS. THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS RCA BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NEITHER AN ISR NOR A CTO LESION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WAS UNKNOWN. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, TWO CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE TOTAL STENT LENGTH WAS 44MM AND THE STENT DIAMETER WAS 3.5MM. HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED 6-9 MONTHS AFTER THE IMPLANT. THE STENT FRACTURE WAS OBSERVED BUT NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE %DS WAS 23% AND POPMA ET AL CLASSIFICATION WAS III.

    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 56 YR Hospitalization| R