BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3083032 · Received April 29, 2013

    Report

    Report Number
    2134265-2013-02697
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED IN TWO SECTIONS TO THE COMPLAINT INVESTIGATION SITE AS A RESULT OF A HYPOTUBE BREAK LOCATED 19.5CM FROM THE STRAIN RELIEF. A MICROSCOPIC EXAMINATION OF THE TIP, BALLOON, AND CRIMPED STENT FOUND NO ISSUES. 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE LESION WAS LOCATED IN THE HEAVILY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. A .9 LASER WAS USED FOLLOWED BY A 1.5X 20 AND 2.0X20MM MAVERICK BALLOON. TWO PROMUS ELEMENT PLUS STENTS WERE DEPLOYED IN THE PROXIMAL CIRCUMFLEX ARTERY (2.5X20MM AND 2.5X12MM). A 2.5 X 8MM PROMUS ELEMENT PLUS STENT WAS THEN ATTEMPTED TO BE ADVANCED DISTAL TO THE TWO PREVIOUSLY PLACED STENTS BUT DUE TO THE CALCIFICATION, THE SHAFT KINKED AND THEN BROKE DUE TO THE EXCESSIVE PUSHING. THE SEPARATION TOOK PLACE OUTSIDE OF THE TOUHY BORST THEREFORE EVERYTHING WAS REMOVED SUCCESSFULLY FROM THE PATIENT. A 2.5 X 15MM MAVERICK BALLOON WAS THEN PLACED TO THE DISTAL LESION AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS DONE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE LESION WAS LOCATED IN THE HEAVILY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. A .9 LASER WAS USED FOLLOWED BY A 1.5X 20 AND 2.0X20MM MAVERICK BALLOON. TWO PROMUS ELEMENT PLUS STENTS WERE DEPLOYED IN THE PROXIMAL CIRCUMFLEX ARTERY (2.5X20MM AND 2.5X12MM). A 2.5 X 8MM PROMUS ELEMENT PLUS STENT WAS THEN ATTEMPTED TO BE ADVANCED DISTAL TO THE TWO PREVIOUSLY PLACED STENTS BUT DUE TO THE CALCIFICATION, THE SHAFT KINKED AND THEN BROKE DUE TO THE EXCESSIVE PUSHING. THE SEPARATION TOOK PLACE OUTSIDE OF THE TOUHY BORST THEREFORE EVERYTHING WAS REMOVED SUCCESSFULLY FROM THE PATIENT. A 2.5 X 15MM MAVERICK BALLOON WAS THEN PLACED TO THE DISTAL LESION AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS DONE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185243 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911408250 15805404

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR