BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1919975 · Received December 10, 2010

    Report

    Report Number
    9616099-2010-00936
    Event Type
    Malfunction
    Date Received
    December 10, 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

    THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN AND NO TREATMENT WAS PROVIDED. POPMA ET AL CLASSIFICATION WAS IV (COMPLETE SEPARATION WITH DISPLACEMENT). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00936 AND 9616099-2010-00937. (B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011. ONLY 1 OF THE 2 STENTS WAS FRACTURED. THIS REPORT IS NO LONGER MDR REPORTABLE. THE ASSOCIATED DEVICE REMAINS MDR REPORTABLE. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00936 AND 9616099-2010-00937. (B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS).

    Description of Event or Problem · 1

    A STENT FRACTURE, WITH SEPARATION AND DISPLACEMENT, AND 28% RESTENOSIS WAS CONFIRMED FOLLOWING IMPLANTATION OF TWO CYPHER BX STENTS. THIS COMPLAINT IS FROM THE AMERICAN HEART JOURNAL 2010; 160:775.E1-775.E9 ARTICLE ENTITLED "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION." THIS CASE IS 16TH 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 LEFT ANTERIOR DESCENDING (LAD) ARTERY, BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NEITHER AN IN-STENT RESTENOSIS NOR A CHRONIC TOTAL OCCLUSION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, TWO CYPHER BX (SIZE AND LOT UNKNOWN) STENTS WERE IMPLANTED WITH OVERLAP. THE TOTAL STENT LENGTH WAS 32MM AND THE STENT DIAMETER WAS 2.5MM. THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED SIX TO NINE MONTHS AFTER THE IMPLANT AND STENT FRACTURE WAS OBSERVED. THERE WAS NO BINARY RESTENOSIS, BUT IT WAS REPORTED THAT THERE WAS 28% STENOSIS.

    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 73 YR