BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1582793 · Received January 18, 2010

    Report

    Report Number
    9616099-2010-00060
    Event Type
    Injury
    Date Received
    January 18, 2010
    Date of Event
    December 5, 2009
    Report Date
    December 22, 2009
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE CRB 23350 (LOT 15026550) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT CXS 233350. THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE TARGET LESION WAS LOCATED IN THE LAD. THE LESION HAD 95% STENOSIS AND WAS CALCIFIED. WHEN THE CYPHER SELECT PLUS STENT REACHED THE PROXIMAL PART OF THE LESION, DIFFICULTY OCCURRED DURING THE DELIVERY PROCESS AND A KINK WAS NOTED AT THE SHAFT NEAR THE HANDLE. IT WAS DIFFICULT TO ADVANCE OR REMOVE THE SDS. FOR SAFETY REASONS, THE PHYSICIAN DECIDED TO DEPLOY THE STENT AT THE PROXIMAL PART OF THE LAD. ANOTHER CYPHER SELECT PLUS STENT WAS THEN IMPLANTED TO FULLY TREAT THE TARGET LESION. THERE WAS NO PT INJURY. THE SDS WAS PREPPED ACCORDING TO IFU. NO RESISTANCE WAS FELT WHILE INSERTING THE DEVICE THROUGH THE GUIDE CATHETER OR SHEATH. THE SDS WILL BE RETURNED FOR EVALUATION.

    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 15026550

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention