BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3932876 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-04178
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND DISTAL STENT DAMAGE WHEREBY THE DISTAL STENT STRUTS PUSHED AND BUNCHED UP PROXIMALLY. A VISUAL EXAMINATION OF THE TIP FOUND NO ISSUES WITH ITS PROFILE. NO ISSUES WERE NOTED WITH THE BALLOON PROFILE. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL EXAMINATION FOUND NO ISSUES WITH ITS TIP PROFILE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE HYPOTUBE PROFILE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT POLYMER EXTRUSION PROFILE. DURING ANALYSIS WHEN A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE TIP, A RESISTANCE WAS MET AT THE PROXIMAL END OF THE STENT. EXAMINATION OF THE BLOCKAGE SITE IDENTIFIED THAT INNER LUMEN WAS BUNCHED AT THE PROXIMAL EDGE OF THE PROXIMAL MARKERBAND. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT DAMAGE OCCURRED. A 2.75X32MM PROMUS ELEMENT PLUS STENT WAS SELECTED TO TREAT THE LESION. WHEN THE DOCTOR WAS TRYING TO LOAD THE STENT OVER THE GUIDEWIRE, THE DISTAL STRUT WAS SLIGHTLY OPENED UP AND AT THE SAME TIME THE COATING OF THE SHAFT OF STENT DELIVERY SYSTEM (SDS) WAS NOT UNIFORM, THE PHYSICIAN REFUSED TO USE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT DAMAGE OCCURRED. A 2.75X32MM PROMUS ELEMENT PLUS STENT WAS SELECTED TO TREAT THE LESION. WHEN THE DOCTOR WAS TRYING TO LOAD THE STENT OVER THE GUIDEWIRE, THE DISTAL STRUT WAS SLIGHTLY OPENED UP AND AT THE SAME TIME THE COATING OF THE SHAFT OF STENT DELIVERY SYSTEM (SDS) WAS NOT UNIFORM, THE PHYSICIAN REFUSED TO USE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410479 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918432270 15899254

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR