BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3761080 · Received April 21, 2014

    Report

    Report Number
    2134265-2014-02156
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED THAT THE CRIMPED STENT WAS DAMAGED ON THE 9TH, 10TH & 11TH ROWS FROM THE DISTAL STENT EDGE. AN EXAMINATION OF THE CRIMPED STENT FOUND THAT THE STENT STRUTS WERE DEFORMED AND LIFTED UPWARDS FROM THE STENT PROFILE. THE BALLOON AND TIP OF THE DEVICE WERE EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES. THE BALLOON WAS TIGHTLY WRAPPED AND DID NOT APPEAR TO HAVE BEEN SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. 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. DEVICE EVALUATION 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).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE FEMORAL ARTERY. THE 100% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND MODERATELY CALCIFIED TOTALLY OCCLUDED RIGHT CORONARY ARTERY. THE TARGET LESION WAS PRE-DILATED WITH A MAVERICK BALLOON CATHETER. DURING ADVANCEMENT OF A 3.0X38MM PROMUS PREMIER STENT, THE STENT ¿WRINKLED.¿ THE STENT WAS REMOVED AND EXCHANGED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE FEMORAL ARTERY. THE 100% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND MODERATELY CALCIFIED TOTALLY OCCLUDED RIGHT CORONARY ARTERY. THE TARGET LESION WAS PRE-DILATED WITH A MAVERICK BALLOON CATHETER. DURING ADVANCEMENT OF A 3.0X38MM PROMUS PREMIER STENT, THE STENT ¿WRINKLED¿. THE STENT WAS REMOVED AND EXCHANGED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240749 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925138300 16625827

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR