BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3953082 · Received July 23, 2014

    Report

    Report Number
    2134265-2014-04324
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER.   DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS TOGETHER WITH THE GUIDEWIRE AND GUIDE CATHETER. A VISUAL EXAMINATION OF THE STENT FOUND THAT THE CRIMPED STENT ON THE DEVICE WAS SEVERELY DAMAGED. AS A CONSEQUENCE, IT WAS NOT POSSIBLE TO MEASURE THE OUTSIDE DIAMETER OF THE CRIMPED STENT. THE EXAMINATION FOUND THAT THE CRIMPED STENT MOVED DISTALLY ON THE BALLOON AND COVERED THE DISTAL MARKERBAND AND DISTAL BALLOON CONE. THE CRIMPED STENT MOVING DISTALLY ON THE BALLOON WOULD SUGGEST THAT THE DEVICE MET RESISTANCE ON AN ATTEMPT TO WITHDRAW THE DEVICE. REVIEWING THESE SPECIFIED PARAMETERS AGAINST THE BATCH RECORDS FOR THE CRIMPED UNIT, THERE ARE NO ANOMALIES EVIDENT. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT POLYMER EXTRUSION PROFILE. THERE IS NO EVIDENCE OF STRETCHING OR DAMAGE TO THE INNER WIRE LUMEN OR THE OUTER LUMEN. NO RESISTANCE WAS MET WHEN ATTEMPTING TO WITHDRAW THIS DEVICE FROM THE GUIDEWIRE DURING ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE CAUSE OF THE REPORTED DIFFICULTIES MAY BE DUE INTERACTION WITH ANOTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS LEFT MAIN TRUNK TO THE MID LEFT ARTERIOR DESCENDING ARTERY. A 16 X 2.25 PROMUS PREMIER¿ STENT WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION; HOWEVER THE DEVICE CAME INTO CONTACT WITH A PREVIOUSLY IMPLANTED UNSPECIFIED SIZE PROMUS PREMIER STENT IN THE LEFT MAIN TRUNK. THUS, THE DEVICE FAILED TO CROSS THE TARGET LESION. THE DEVICE WAS ATTEMPTED TO BE REMOVED. WHEN THE DEVICE WAS RETRACTED INTO AN UNSPECIFIED GUIDE CATHETER, THE DEVICE CAME INTO CONTACT WITH THE TIP OF THE GUIDE CATHETER. IT WAS THEN NOTED THAT THE STENT WAS LIFTED AND DAMAGED. EVERYTHING WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS NOT COMPLETED DUE TO THE UNAVAILABILITY OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS LEFT MAIN TRUNK TO THE MID LEFT ARTERIOR DESCENDING ARTERY. A 16 X 2.25 PROMUS PREMIER¿ STENT WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION; HOWEVER THE DEVICE CAME INTO CONTACT WITH A PREVIOUSLY IMPLANTED UNSPECIFIED SIZE PROMUS PREMIER STENT IN THE LEFT MAIN TRUNK. THUS, THE DEVICE FAILED TO CROSS THE TARGET LESION. THE DEVICE WAS ATTEMPTED TO BE REMOVED. WHEN THE DEVICE WAS RETRACTED INTO AN UNSPECIFIED GUIDE CATHETER, THE DEVICE CAME INTO CONTACT WITH THE TIP OF THE GUIDE CATHETER. IT WAS THEN NOTED THAT THE STENT WAS LIFTED AND DAMAGED. EVERYTHING WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS NOT COMPLETED DUE TO THE UNAVAILABILITY OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432389 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925116220 16863997

    Patients

    Seq Age Sex Outcome Treatment
    1