BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3894018 · Received June 25, 2014

    Report

    Report Number
    2134265-2014-03680
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: ABOVE 60 YEARS OF AGE. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE TIP OD WAS MEASURED USING A DIGITAL SNAP GAUGE WHICH IS WITHIN SPECIFICATION. THE STENT WAS DAMAGED AT THE DISTAL END. THE STRUTS ON THE FOUR MOST DISTAL ROWS WERE STRETCHED AND RAISED VERTICALLY. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE DURING THE WITHDRAWAL FROM THE PATIENT. THE HYPOTUBE AND OUTER WERE BOTH KINKED AT VARIOUS LOCATIONS ALONG THEIR LENGTH. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE CHRONIC TOTAL OCCLUSION TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). AN UNSPECIFIED GUIDE WIRE WAS FIRST ADVANCE AND CROSSED THE LESION THEN THIS WAS EXCHANGED TO A NON BSC GUIDE WIRE. THE 2.50MM X 20MM PROMUS PREMIER¿ STENT WAS ADVANCED BUT WAS NOT ABLE TO CROSS THE LESION, SO THE DEVICE WAS REMOVED AND A 2.5MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED TO PREDILATE THE LESION. THEN THE 2.50MM X 20MM PROMUS PREMIER¿ STENT WAS AGAIN LOADED INTO THE GUIDE WIRE HOWEVER IT WAS NOTICED THAT THE FRONT END OF THE STENT HAD LIFTED OFF THE DELIVERY SYSTEM BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE AND AN UNSPECIFIED STENT WAS IMPLANTED IN THE REMAINING PORTION OF THE RCA. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE CHRONIC TOTAL OCCLUSION TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). AN UNSPECIFIED GUIDE WIRE WAS FIRST ADVANCE AND CROSSED THE LESION THEN THIS WAS EXCHANGED TO A NON BSC GUIDE WIRE. THE 2.50MM X 20MM PROMUS PREMIER¿ STENT WAS ADVANCED BUT WAS NOT ABLE TO CROSS THE LESION, SO THE DEVICE WAS REMOVED AND A 2.5MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED TO PREDILATE THE LESION. THEN THE 2.50MM X 20MM PROMUS PREMIER¿ STENT WAS AGAIN LOADED INTO THE GUIDE WIRE HOWEVER IT WAS NOTICED THAT THE FRONT END OF THE STENT HAD LIFTED OFF THE DELIVERY SYSTEM BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE AND AN UNSPECIFIED STENT WAS IMPLANTED IN THE REMAINING PORTION OF THE RCA. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371897 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952820250 0016745020

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: PROWATER