BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 4243640 · Received November 11, 2014

    Report

    Report Number
    2134265-2014-06780
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. THE DEVICE WAS RECEIVED AT THE COMPLAINT INVESTIGATION SITE WITH THE STENT DETACHED FROM THE DELIVERY SYSTEM. THE STENT OF THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BALLOON WAS FOUND TO HAVE STENT IMPRESSIONS INDICATING THAT THE STENT WAS CRIMPED IN THE CORRECT LOCATION DURING MANUFACTURING. THE BALLOON WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. IT WAS NOTED THAT ALL FIVE BALLOON FOLDS WERE PRESENT. THE BALLOON WAS TIGHTLY WRAPPED, EVENLY FOLDED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUE WITH THE PROFILE. A VISUAL AND TACTILE EXAMINATION FOUND NO KINKS OR DAMAGE 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 CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. A 20 X 4.00 PROMUS PREMIER¿ DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. DURING PREPARATION, THE PHYSICIAN SLIGHTLY MANIPULATED THE DEVICE CAUSING THE STENT TO COME OFF THE DELIVERY BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROMUS PREMIER¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE THROUGHOUT THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT WHEN THE STENT DISLODGED, THE PHYSICIAN DISCARDED THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727019 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925120400 17060655

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR