BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3931166 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-04012
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND STENT STRUTS ON THE DISTAL PORTION OF THE CRIMPED STENT WAS DISTORTED, BUNCHED AND LIFTED UPWARDS FROM THE STENT PROFILE. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT POLYMER EXTRUSION PROFILE. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED WITH A NON BSC BALLOON CATHETER AND AN INTRAVASCULAR ULTRASOUND (IVUS) WAS THEN PERFORMED. SUBSEQUENTLY, AFTER A 3.5 NON-BSC GUIDE CATHETER WAS ADVANCED, A 24 X 3.00 PROMUS PREMIER DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, SEVERE RESISTANCE WAS ENCOUNTERED AND IT WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS THEN REMOVED OUTSIDE THE PATIENT'S BODY AND IT WAS NOTED THAT THE STENT WAS FULLY STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED WITH A NON BSC BALLOON CATHETER AND AN INTRAVASCULAR ULTRASOUND (IVUS) WAS THEN PERFORMED. SUBSEQUENTLY, AFTER A 3.5 NON-BSC GUIDE CATHETER WAS ADVANCED, A 24 X 3.00 PROMUS PREMIER¿ DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, SEVERE RESISTANCE WAS ENCOUNTERED AND IT WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS THEN REMOVED OUTSIDE THE PATIENT'S BODY AND IT WAS NOTED THAT THE STENT WAS FULLY STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410784 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925124300 16837432

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDING CATHETER: HEART RAIL IL 3.5| GUIDE WIRE: SION| INTRODUCER SHEATH: TRM| BALLOON CATHETER: HIRYU| INFLATION DEVICE: BSJ