BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3994193 · Received August 8, 2014

    Report

    Report Number
    2134265-2014-04642
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 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

    DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. THE TIP OD WAS MEASURED AND IS WITHIN SPECIFICATION. THE CRIMPED STENT, BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND THAT THE HYPOTUBE WAS KINKED 507MM DISTAL TO THE STRAIN RELIEF. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. 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 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

    IT WAS REPORTED THAT A STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 12 X 2.25 PROMUS PREMIER¿ STENT WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION DUE TO SEVERE CALCIFICATION. THEN THE PHYSICIAN ATTEMPTED TO CROSS THE DEVICE THROUGH A NON BSC GUIDE CATHETER EXTENSION HOWEVER THE DISTAL EDGE OF THE STENT WAS CAUGHT IN THE EXIT PORT OF THE GUIDE CATHETER EXTENSION. IT WAS THEN NOTICED THAT THE EDGE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT DAMAGE WAS OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 12 X 2.25 PROMUS PREMIER¿ STENT WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION DUE TO SEVERE CALCIFICATION. THEN THE PHYSICIAN ATTEMPTED TO CROSS THE DEVICE THROUGH A NON BSC GUIDE CATHETER EXTENSION HOWEVER THE DISTAL EDGE OF THE STENT WAS CAUGHT IN THE EXIT PORT OF THE GUIDE CATHETER EXTENSION. IT WAS THEN NOTICED THAT THE EDGE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472669 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925112220 0016733369

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: SION BLUE/ASAHI INTECC| GUIDING CATHETER: MACH1/VL3.5/BSJ| GUIDE CATHETER EXTENSION: GUIDELINER| BALLOON CATHETER: EMERGE/15MM/1.5MM/BSJ| INTRODUCER SHEATH: SUPER SHEATH/6F/MEDIKIT