BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1201531 · Received October 17, 2008

    Report

    Report Number
    9616099-2008-02472
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    April 11, 2008
    Report Date
    September 19, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING NUMBER: 9616099-2008-02471. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE STUDY INDICATED THAT EIGHT-MONTHS POST PROCEDURE, STENT RESTENOSIS WAS IDENTIFIED. THE INDEX PROCEDURE INCLUDED TREATMENT OF A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE TARGET LESION DID NOT PRESENT A DETERMINABLE MORPHOLOGY, NOT CALCIFIED, NO THROMBUS AND TIMI 0. THE LESION WAS PREDILATED AND THEN A 2.5 X 33MM AND A 3.0 X 18MM WERE DEPLOYED AT 14 ATMOSPHERES. DURING THE EIGHT-MONTH FOLLOW UP, ANGIOGRAPHIC CONTROL WAS CONDUCTED REVEALING SUB-OCCLUSIVE RESTENOSIS IN THE MID RCA 99%. THE RESTENOTIC LESION WAS TREATED WITH CUTTING BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DURG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA I1206006

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R STATINS| ACE INHIBITORS| UNFRACTIONATED HEPARIN.| PRODUCTS PREDILATATION BALLOON GUIDANT CROSS| MEDICATION ASA| CLOPIDOGREL| BETA-BLOCKERS