BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3123901 · Received May 22, 2013

    Report

    Report Number
    2134265-2013-03330
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: VISUAL EXAMINATION OF THE RETURNED UNIT FOUND A NUMBER OF DARK COLORED FIBERS ENTWINED IN THE STENT AT ITS PROXIMAL END. THE DEVICE WAS NOT RETURNED IN ITS ORIGINAL PACKAGING. THE FIBROUS SAMPLES WERE BARELY VISIBLE TO THE NAKED EYE AND WERE FIRST ANALYSED UNDER AN OPTICAL MICROSCOPE. TO IDENTIFY THE FIBER IT WAS ANALYSED USING FOURIER TRANSFORM INFRA-RED SPECTROSCOPY (FTIR). FROM BOTH THE SCANNING ELECTRON MICROSCOPE (SEM) IMAGES AND THE (FTIR) SPECTRA IT APPEARS THAT THE SAMPLES ARE POLYESTER FIBERS. IMAGES OF THE STENT ARE ALSO TAKEN POST THE STENT CRIMPING PROCESS JUST BEFORE THE STENT PROTECTOR IS POSITIONED OVER THE STENT. VISUAL REVIEW OF THESE IMAGES SHOWS NO EVIDENCE OF ANY FOREIGN MATERIAL (FM) ON THE STENT PRIOR TO PACKAGING. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, FOREIGN MATERIAL WAS IDENTIFIED. UPON REMOVING A 2.75X24MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM FROM THE STERILE BAG, FIBERS WERE NOTED ON THE STENT. THE DEVICE DID NOT ENTER THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, FOREIGN MATERIAL WAS IDENTIFIED. UPON REMOVING A 2.75X24MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM FROM THE STERILE BAG, FIBERS WERE NOTED ON THE STENT. THE DEVICE DID NOT ENTER THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226213 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911424270 0015811508

    Patients

    Seq Age Sex Outcome Treatment
    1