BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1003576 · Received February 25, 2008

    Report

    Report Number
    9616099-2008-00438
    Event Type
    Injury
    Date Received
    February 25, 2008
    Report Date
    January 28, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED; ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. PLEASE FIND BELOW THE ARTICLE'S CITATION ALONG WITH A COPY OF THE ARTICLE, WHICH IS BEING ATTACHED TO THIS REPORT. OHGO, T., OTSUKA, Y. AND FURUNO T., 20 FEB 2007. COMPLETE FRACTURE AND RESTENOSIS OF SIROLIMUS ELUTING STENT IN OSTIAL SAPHENOUS VEIN GRAFT, INTERNATIONAL JOURNAL OF CARDIOLOGY. [SEE SCANNED PAGES.]

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE, THREE MONTHS POST STENT IMPLANT, THE PATIENT PRESENTED WITH CHEST PAIN; A CORONARY ANGIOGRAM REVEALED 99% IN-STENT RESTENOSIS WITH COMPLETE STENT FRACTURE. THE STENTING PROCEDURE INCLUDED TREATMENT OF A 90% STENOSIS OF THE OSTIAL SAPHENOUS VEIN GRAFT TO THE RIGHT CORONARY ARTERY. DURING THE PROCEDURE, THE 3.0 X 13 MM CYPHER STENT WAS IMPLANTED, A FINAL CORONARY ANGIOGRAM SHOWED A WELL-DEPLOYED STENT WITHOUT RESIDUAL STENOSIS OR DISSECTION. THREE MONTHS AFTER STENT IMPLANT, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN; AN EMERGENT CORONARY ANGIOGRAM REVEALED 99% IN-STENT RESTENOSIS WITH COMPLETE FRACTURE AT THE MID-PORTION OF THE STENT. AS A RESULT, THE PATIENT UNDERWENT REDO CORONARY ARTERY BYPASS GRAFT SURGERY.

    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 82 YR Hospitalization| L| R