BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1860812 · Received October 7, 2010

    Report

    Report Number
    3003742446-2010-00350
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. STENT DISLODGMENT IS A KNOWN POTENTIAL PROCEDURAL COMPLICATION ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. THE IFU CAUTIONS THAT IF RESISTANCE IS ENCOUNTERED AT ANY TIME DURING DELIVERY OF THE DEVICE, THAT THE DEVICE SHOULD BE REMOVED AS A SINGLE UNIT WITH THE GUIDE. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT VESSEL/LESION CHARACTERISTICS AND/OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION IN THE REPORT OR THE DHR TO INDICATE THAT THERE IS A DESIGN OR MANUFACTURING ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO CATH LAB FOR LEFT HEART CATH. THERE WERE NO ANOMALIES WITH THE DEVICE PRIOR TO USE AND THE DEVICE PREPPED ACCORDING TO IFU. THE PATIENT HAD A LESION TO THE MID-LEFT ANTERIOR DESCENDING ARTERY. THE VESSEL WAS CALCIFIED AND STRAIGHT FORWARD. THE PHYSICIAN PLACE A GUIDEWIRE THROUGH THE LESION THEN ATTEMPTED TO PASS THE STENT THROUGH THE LESION. WHILE PULLING THE GUIDE CATHETER BACK, THE CYPHER US RX 2.50 X 18 CAME OFF. THE STENT WAS STILL ON THE GUIDEWIRE. THE PHYSICIAN WAS ABLE TO INSERT A BALLOON CATHETER WITHIN THE STENT AND DEPLOY STENT PROXIMAL TO THE LESION. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15177926

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention