BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1664826 · Received April 22, 2010

    Report

    Report Number
    9616099-2010-00300
    Event Type
    Injury
    Date Received
    April 22, 2010
    Date of Event
    March 30, 2010
    Report Date
    March 30, 2010
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. CROSSING PROFILE INSPECTION RECORDS WERE REVIEWED AND THIS LOT WAS DEEMED ACCEPTABLE. FPI AND LPI CROSSING PROFILE TEST RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND. STENT RETENTION INSPECTION RECORDS WERE REVIEWED AND THIS LOT WAS DEEMED ACCEPTABLE. FPI AND LPI STENT RETENTION TEST RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND. STENT DISLODGEMENT AND STRUT UPLIFT AS WELL AS FAILURE TO CROSS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. THE IFU RECOMMENDS THAT WHEN WITHDRAWING THE STENT IT SHOULD BE REMOVED AS ONE UNIT WITH THE GUIDE AND NOT WITHDRAWN INTO THE GUIDE. THE IFU ALSO RECOMMENDS THAT WHEN RESISTANCE IS MET (USE OF VIBRATION TECHNIQUE TO TRY AND CROSS THE LESION) THE PRODUCT SHOULD BE REMOVED AND THE SOURCE OF THE RESISTANCE ESTABLISHED. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE STENT DISLODGMENT, STRUT UP-LIFT AND FAILURE TO CROSS MAY BE RELATED TO VESSEL/LESION CHARACTERISTICS AND/OR PROCEDURAL FACTORS. THERE IS NOTHING TO INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS NEEDED. CONCOMITANT PRODUCTS: INFLATION DEVICE: EVEREST. GW: SUOH, RUNTHROUGH, EXTRA FLOPPY. GC: LAUNCHER 6F SAL1, ACCESS 6F AL1. BC: APEX 2.5/15MM. SHEATH: TERUMO'S 6F.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM AN AFFILIATE INDICATED THAT A STENT FAILED TO CROSS THE LESION, BECAME DISLODGED, AND STRUT UP-LIFT WAS IDENTIFIED AFTER IT WAS REMOVED FROM THE PATIENT. THE TARGET LESION WAS THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS DESCRIBED AS DE NOVO, MODERATELY CALCIFIED, SLIGHTLY TORTUOUS AND HAVING 99% STENOSIS. A LAUNCHER GUIDE CATHETER WAS ENGAGED AND THE LESION WAS PRE-DILATED WITH A 2.5 X 15MM APEX BALLOON, BUT THE RESIDUAL STENOSIS WAS UNKNOWN. A 3.0 X 33MM CYPHER WAS DELIVERED TO THE TARGET LESION, BUT WOULD NOT CROSS THE LESION. A VIBRATION TECHNIQUE WAS CONDUCTED, BUT THE CYPHER COULD NOT BE DELIVERED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE CYPHER FROM THE PATIENT, BUT THE PROXIMAL EDGE OF THE STENT BECAME STUCK AT THE TIP OF THE GUIDE CATHETER. WHEN THE PHYSICIAN PULLED THE CYPHER BACK INTO THE GUIDE CATHETER, THE STENT WAS CONFIRMED TO BE DISLODGED ON THE GUIDEWIRE. THE STENT DELIVERY SYSTEM WAS RETRIEVED AND THE DISLODGED CYPHER STENT WAS SAFELY REMOVED USING A SNARE CATHETER. FOLLOWING REMOVAL OF THE STENT, IT WAS CONFIRMED THAT THE PROXIMAL EDGE OF THE STENT WAS FLARED AND THE STENT WAS DEFORMED.

    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 15079716

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention