BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3111159 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03338
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE 2915 RELATES TO COMPONENT CODE 515. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: ONLY THE STENT WAS RETURNED FOR ANALYSIS. THE STENT WAS SEVERELY DAMAGED THROUGHOUT. THE STENT WAS STRETCHED AND DEFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CAUSED BY OTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. A 4.00X38MM PROMUS ELEMENT PLUS STENT WAS USED TO TREAT THE UNKNOWN TARGET LESION. A NON-BSC EMBOLIC PROTECTION DEVICE (EPD) WAS DEPLOYED DISTAL TO THE STENT. THE STENT WAS THEN DEPLOYED AT THE RATED BURST PRESSURE. AFTER DEPLOYMENT, THEY ATTEMPTED TO RETRIEVE AND TAKE OUT THE EPD BUT IT CAUGHT UP WITH THE STENT. STENT DEFORMATION WAS THEN NOTED. THE STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. A 4.00X38MM PROMUS ELEMENT PLUS STENT WAS USED TO TREAT THE UNKNOWN TARGET LESION. A NON-BSC EMBOLIC PROTECTION DEVICE (EPD) WAS DEPLOYED DISTAL TO THE STENT. THE STENT WAS THEN DEPLOYED AT THE RATED BURST PRESSURE. AFTER DEPLOYMENT, THEY ATTEMPTED TO RETRIEVE AND TAKE OUT THE EPD BUT IT CAUGHT UP WITH THE STENT. STENT DEFORMATION WAS THEN NOTED. THE STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213070 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911438400 15381374

    Patients

    Seq Age Sex Outcome Treatment
    1 Other