BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1161269 · Received September 12, 2008

    Report

    Report Number
    9616099-2008-02228
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 16, 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 HAS BEEN RETURNED FOR EVAL, HOWEVER, THE ENGINEERING EVAL IS NOT YET COMPLETE. THE PRODUCT IS NOT DISTRIBUTED IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE EVENT RECEIVED FROM THE AFFILIATE INDICATED THAT THE FEMALE PT WAS ADMITTED EMERGENTLY FOR TREATMENT OF MULTI-VESSEL DISEASE. THE FIRST LESION WAS A 75% STENOSIS FLEXED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A 99% STENOSIS IN THE LEFT CIRCUMFLEX (LCX). THE LESIONS WERE DE NOVO, SLIGHTLY CALCIFIED BUT NOT TORTUOUS. THE LESION IN THE LAD WAS PRE-DILATED AND A 2.5X18MM CYPHER STENT WAS IMPLANTED SUCCESSFULLY. THE LESION IN THE LCX WAS PRE-DILATED WITH A 1.5 X 20 MM APEX BALLOON. A 2.5 X 18MM CYPHER WAS BEING DELIVERED, HOWEVER, FRICTION WAS ENCOUNTERED, AND IT BECAME STUCK WITHIN THE VESSEL PRIOR TO REACHING THE TARGET LESION. THE PHYSICIAN PUSHED THE CYPHER BACK AND FORTH IN ORDER TO CROSS THE TARGET LESION WITH THE CYPHER, BUT THE STENT DISLODGED. THE STENT WAS WITHDRAWN WITH A GOOSENECK SNARE. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY ONLY. AS REPORTED, THERE WAS PT INJURY. THE COMPLAINT PRODUCT AND SNARE WILL BE RETURNED FOR ANALYSIS. THE PHYSICIAN DID NOT INDICATE IF THERE WERE ANY ANOMALIES PRIOR TO USE. THE PHYSICIAN INDICATED THAT IN THE PAST, THE STENT DID NOT DISLODGE WHEN IT WAS MOVED BACK AND FORTH. BECAUSE THIS TIME IT DISLODGED THE PHYSICIAN IS WONDERING IF THERE WAS ANY CRIMPING FAILURE. TO TREAT THE LESION IN THE LAD, A GUIDE WIRE (RUNTHROUGH) WAS USED. THE LESION WAS THEN PRE-DILATED WITH A 2.0X20MM SPRINTER BALLOON. THE 2.5X18MM CYPHER STENT WAS POST-DILATED WITH A 2.25X10MM HIRYU BALLOON. TO TREAT THE LESION IN THE LEFT CIRCUMFLEX A RUNTHROUGH GUIDEWIRE WAS USED. THE LESION WAS PRE-DILATED WITH A 1.5X20MM APEX BALLOON AND THEN THE 2.5X18MM CYPHER STENT WAS IMPLANTED.

    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 13412116

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 0.14 RUNTHROUGH| 7 FR LAUNCHER (EBU 3.5)| 2.0 X 20MM SPRINTER BALLOON CATHETER| 2.25X10MM HIRYU| 1.5 X 20MM APEX WERE USED.