BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3001891 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01557
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE IDENTIFIED A SHAFT HYPOTUBE BREAK LOCATED 19CM FROM THE CATHETER STRAIN RELIEF. A VISUAL AND MICROSCOPIC EXAMINATION ALSO IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE CRIMPED STENT, BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE GUIDE WIRE LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    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 THAT DURING A CORONARY ANGIOPLASTY TREATMENT PROCEDURE, SHAFT BREAKAGE OCCURRED. THE LESION WAS SITUATED IN THE ANTERIOR DESCENDING (DA) ARTERY. A PROMUS STENT WAS SUCCESSFULLY IMPLANTED DISTALLY. THE PROMUS ELEMENT 32X2.5MM WAS THEN ADVANCED TO COVER THE MIDDLE THIRD OF THE DA. A LOT OF CALCIFICATION WAS ENCOUNTERED. MORE FORCE WAS APPLIED TO REACH THE LESION AND THE SHAFT BROKE 19CM FROM THE CATHETER HUB, OUTSIDE THE PATIENT. THE DELIVERY SYSTEM WAS EASILY REMOVED AND A NON BSC STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ANGIOPLASTY TREATMENT PROCEDURE, SHAFT BREAKAGE OCCURRED. THE LESION WAS SITUATED IN THE ANTERIOR DESCENDING (DA) ARTERY. A PROMUS STENT WAS SUCCESSFULLY IMPLANTED DISTALLY. THE PROMUS ELEMENT 32X2.5MM WAS THEN ADVANCED TO COVER THE MIDDLE THIRD OF THE DA. A LOT OF CALCIFICATION WAS ENCOUNTERED. MORE FORCE WAS APPLIED TO REACH THE LESION AND THE SHAFT BROKE 19CM FROM THE CATHETER HUB, OUTSIDE THE PATIENT. THE DELIVERY SYSTEM WAS EASILY REMOVED AND A NON BSC STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106026 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332250 15021927

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR