BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3863580 · Received June 10, 2014

    Report

    Report Number
    2134265-2014-03114
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION FOUND NO DEFECTS ON THE BALLOON SECTION OF THE DEVICE. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THE MID TO DISTAL END OF THE STENT WAS BUNCHED, RAISED AND MISALIGNED. AN EXAMINATION FOUND THAT THERE WERE VARIOUS HYPOTUBE KINKS ALONG THE LENGTH OF THE UNIT. 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

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

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-03115, 2134265-2014-03116, AND 2134265-2014-03117. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE HIGHLY DIFFUSED, SEVERELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY (RCA) WITH SEVERAL EXTREMELY ACUTE ANGLES. THE PHYSICIAN FIRST USED A 1.2 X 12MM EMERGE PUSH BALLOON CATHETER TO PREDILATE THE PROXIMAL TO MID RCA, THEN USED A 1.50MM X 12MM EMERGE¿ PUSH BALLOON CATHETER, BUT IT RUPTURED UPON SECOND INFLATION AT NOMINAL ATMOSPHERES. A 2.0 X 12MM NC QUANTUM APEX AND A 2.5 X 15MM NC QUANTUM APEX BALLOON CATHETERS WERE THEN USED TO PREDILATE THE LESION. 3.0 X 24 PROMUS PREMIER¿, 3.5 X 24 PROMUS PREMIER¿, AND 3.0 X 20 PROMUS PREMIER¿ STENT DELIVERY SYSTEMS WERE SELECTED TO TREAT THE LESION BUT ALL THREE FAILED TO CROSS THE LESION AND RESULTED IN A NOTICEABLE FLARE IN THE DISTAL PART OF THE STENTS. THEN A 3.5 X 28 SYNERGY STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION BUT WAS STILL UNABLE TO CROSS. SEVERAL NON COMPLIANT BALLOON CATHETERS WERE USED TO BREAK THE PLAQUE AND A 3.5 X 28 SYNERGY, 3.0 X 20 SYNERGY, AND 3.0 X 16 PROMUS PREMIER STENT DELIVERY SYSTEMS WERE USED TO FINISH THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE HIGHLY DIFFUSED, SEVERELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY (RCA) WITH SEVERAL EXTREMELY ACUTE ANGLES. THE PHYSICIAN FIRST USED A 1.2 X 12MM EMERGE PUSH BALLOON CATHETER TO PREDILATE THE PROXIMAL TO MID RCA, THEN USED A 1.50MM X 12MM EMERGE¿ PUSH BALLOON CATHETER, BUT IT RUPTURED UPON SECOND INFLATION AT NOMINAL ATMOSPHERES. A 2.0 X 12MM NC QUANTUM APEX AND A 2.5 X 15MM NC QUANTUM APEX BALLOON CATHETERS WERE THEN USED TO PREDILATE THE LESION. 3.0 X 24 PROMUS PREMIER¿, 3.5 X 24 PROMUS PREMIER¿, AND 3.0 X 20 PROMUS PREMIER¿ STENT DELIVERY SYSTEMS WERE SELECTED TO TREAT THE LESION BUT ALL THREE FAILED TO CROSS THE LESION AND RESULTED IN A NOTICEABLE FLARE IN THE DISTAL PART OF THE STENTS. THEN A 3.5 X 28 SYNERGY STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION BUT WAS STILL UNABLE TO CROSS. SEVERAL NON COMPLIANT BALLOON CATHETERS WERE USED TO BREAK THE PLAQUE AND A 3.5 X 28 SYNERGY, 3.0 X 20 SYNERGY, AND 3.0 X 16 PROMUS PREMIER STENT DELIVERY SYSTEMS WERE USED TO FINISH THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338449 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925120300 16629640

    Patients

    Seq Age Sex Outcome Treatment
    1