BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1832768 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-03971
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    July 7, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION FOUND STENT DAMAGE. THE ENTIRE LENGTH OF THE STENT WAS MISALIGNED. THE STRUTS ON ROWS 1 TO 3 FROM THE PROXIMAL EDGE WERE RAISED. THE STENT MOVED DISTALLY ON THE BALLOON SO THAT THE DISTAL EDGE OF THE STENT WAS 1MM DISTAL TO THE DISTAL MARKERBAND. THE TIP WAS SLIGHTLY PINCHED AND ATTEMPTS TO INSERT A 0.015 INCH PRODUCT MANDREL WERE UNSUCCESSFUL. THIS TYPE OF DAMAGE IS CONSISTENT WITH GUIDEWIRE MOVEMENT DURING ATTEMPTS TO CROSS THE LESION. THE BALLOON SECTION OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. 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 INVESTIGATION ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STENT DID NOT CROSS A PREVIOUSLY PLACED STENT. THE 32-33MM, 85% STENOSED LESION BEING TREATED WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED USING A MAVERICK 2.0X15MM BALLOON. FIRST, A 2.5X16MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS PLACED IN THE MID LAD. THEN THIS 2.5X16MM PROMUS ELEMENT SDS WAS ADVANCED TO THE LESION, BUT COULD NOT CROSS THE PREVIOUSLY PLACED 2.5X16MM PROMUS ELEMENT STENT. THE PROVIDER POST DILATED THE FIRST STENT AND A SECOND CROSSING ATTEMPT FAILED. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER UNSPECIFIED REASON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, THE PRODUCT ANALYSIS REVEALED STENT DAMAGE AND STENT MOVEMENT ON THE BALLOON. THIS PRODUCT IS ONLY OUS 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 H7493911316250 13474691

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 2.0 X 15MM MAVERICK BALLOON