BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1960416 · Received January 13, 2011

    Report

    Report Number
    2134265-2010-05874
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE REVEALED THAT THE STENT WAS RETURNED DETACHED FROM THE DELIVERY DEVICE. THE STENT WAS DAMAGED THROUGHOUT. INVESTIGATION OF THE DELIVERY DEVICE REVEALED THAT THE BALLOON HAD STENT IMPRESSIONS ON IT AND PILLOWING INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THE MIDSHAFT WAS KINKED AND TWISTED FROM THE PORT AREA TO 30MM PROXIMAL TO THE PORT AND A LARGE KINK 15MM PROXIMAL TO THE PORT. THE TIP WAS KINKED 5MM PROXIMAL TO THE END OF THE TIP. A PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 90-95% STENOSED, 24X3.5MM, DE NOVO TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH A 2.0X20MM MAVERICK BALLOON. NEXT, A 3.0X24MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS INSERTED HOWEVER THERE WAS MILD RESISTANCE ADVANCING THE SDS IN THE 6F SHEATH AND THE STENT DISLODGED. THE STENT WAS REMOVED FROM THE Y-ADAPTER BY HAND AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 90-95% STENOSED, 24X3.5MM, DE NOVO TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH A 2.0X20MM MAVERICK BALLOON. NEXT, A 3.0X24MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS INSERTED HOWEVER THERE WAS MILD RESISTANCE ADVANCING THE SDS IN THE 6F SHEATH AND THE STENT DISLODGED. THE STENT WAS REMOVED FROM THE Y-ADAPTER BY HAND AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY (B)(4) APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324300 13423682

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR BMW 0.104 GUIDE WIRE