BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2170499 · Received July 21, 2011

    Report

    Report Number
    2134265-2011-02888
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    March 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED DISTAL AND PROXIMAL STENT DAMAGE. THE STRUTS ON THE FIRST ROW AT EACH END OF THE STENT WERE FLARED. THE BALLOON WAS FOUND TO BE PARTIALLY INFLATED AT BOTH ENDS. NO ISSUES WERE NOTED WITH THE TIP THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. A MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. SOLIDIFIED CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN PREPPED FOR USE. 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

    REPORTABLE BASED ON THE ANALYSIS COMPLETED (B)(6) 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, THE DEVICE WOULD NOT CROSS A PREVIOUSLY PLACED STENT. VASCULAR ACCESS WAS GAINED VIA THE RADIAL ARTERY. THE LESION BEING TREATED WAS LOCATED IN PROXIMAL CIRCUMFLEX (CX) ARTERY. THE LESION WAS WIRED WITH TWO FORTE FLOPPY WIRES AND A PT2 GUIDE WIRE THEN PRE-DILATED WITH A 1.5X15MM APEX AND A 2.0X15MM APEX BALLOONS. THE 2.25X20MM PROMUS ELEMENT WAS ADVANCED AND WOULD NOT CROSS THE STENT IN THE LEFT MAIN CORONARY ARTERY (LMCA). TWO GUIDES WERE REMOVED AND PHYSICIAN ATTEMPTED TO CROSS THE LESION AGAIN; AGAIN THE DEVICE WOULD NOT CROSS THE PLACED STENT. ALL OF THE DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITHOUT IMPLANTING A STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS STABLE. RETURNED PRODUCT ANALYSIS REVELED STENT DAMAGE. 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 H7493911320220 13681965

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR GUIDE WIRE: FORTÉ FLOPPY| BALLOON CATH: APEX 1.5MMX15MM| GUIDE WIRE: PT2| GUIDE WIRE: FORTÉ FLOPPY| BALLOON CATH: APEX 2.0MMX15MM