BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3833660 · Received May 27, 2014

    Report

    Report Number
    2134265-2014-02887
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT WAS DAMAGED AT THE DISTAL END. THE STRUTS ON THE FOUR MOST DISTAL ROWS WERE MISALIGNED AND DISTORTED. THE INVESTIGATOR ALSO OBSERVED THAT THE TIP WAS SLIGHTLY FLARED. THIS TYPE OF DAMAGE IS CONSISTENT WITH MEETING AN OBSTRUCTION DURING AN ATTEMPT TO CROSS A LESION. THE BALLOON WAS TIGHTLY WRAPPED AND DID NOT APPEAR TO HAVE BEEN SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE IDENTIFIED ALONG THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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 STENT DAMAGE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE OBTUSE MARGINAL BRANCH ARTERY. A 2.75X12MM PROMUS PREMIER¿ WAS SELECTED AND ATTEMPTS WERE MADE TO ADVANCE THE DEVICE THROUGH A NON BSC STENT PLACED IN A TORTUOUS CIRCUMFLEX (CX) ARTERY. THE STENT GOT CAUGHT UP ON A PREVIOUSLY PLACED NON BSC STENT IN THE CX ARTERY AND THE STENT COULD NOT BE DELIVERED. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE DISTAL END OF THE STENT HAS MALFORMED. ATTEMPTS WERE MADE TO CROSS THE TOURTOUS CX USING AND UNKNOWN MANUFACTURER¿S STENT; HOWEVER THE STENT COULD NOT CROSS THE CX. A 7.0X20MM QUANTUM APEX BALLOON CATHETER ALSO FAILED TO CROSS THE LESION. EVENTUALLY THE PHYSICIAN WAS ABLE TO TREAT THE LESION WITH ANGIOPLASTY USING AN UNKNOWN MANUFACTURER¿S BALLOON CATHETER. THERE WERE NO PATIENT ISSUES AND THE PATIENT¿S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE OBTUSE MARGINAL BRANCH ARTERY. A 2.75X12MM PROMUS PREMIER¿ WAS SELECTED AND ATTEMPTS WERE MADE TO ADVANCE THE DEVICE THROUGH A NON BSC STENT PLACED IN A TORTUOUS CIRCUMFLEX (CX) ARTERY. THE STENT GOT CAUGHT UP ON A PREVIOUSLY PLACED NON BSC STENT IN THE CX ARTERY AND THE STENT COULD NOT BE DELIVERED. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE DISTAL END OF THE STENT HAS MALFORMED. ATTEMPTS WERE MADE TO CROSS THE TORTUOUS CX USING AND UNKNOWN MANUFACTURER¿S STENT; HOWEVER, THE STENT COULD NOT CROSS THE CX. A 7.0X20MM QUANTUM APEX BALLOON CATHETER ALSO FAI,LED TO CROSS THE LESION. EVENTUALLY THE PHYSICIAN WAS ABLE TO TREAT THE LESION WITH ANGIOPLASTY USING AN UNKNOWN MANUFACTURER¿S BALLOON CATHETER. THERE WERE NO PATIENT ISSUES AND THE PATIENT¿S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310461 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952812270 16656263

    Patients

    Seq Age Sex Outcome Treatment
    1