BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2230952 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03607
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    June 14, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED THAT THE TIP OF THE DEVICE WAS SLIGHTLY DAMAGED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE TIP BEING PUSHED UP AGAINST A RESTRICTION, DURING ATTEMPTS TO CROSS THE LESION. IT WAS NOTED THAT THE ENTIRE LENGTH OF THE STENT WAS RAISED FROM THE BALLOON AND MISALIGNED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. IT WAS NOTED THAT THE BALLOON WAS PARTIALLY INFLATED. THE HYPOTUBE WAS KINKED ALONG ITS ENTIRE LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE GUIDEWIRE LUMEN WITH NO RESTRICTIONS NOTED. DURING PRODUCT ANALYSIS THE BALLOON OF THIS DEVICE WAS INFLATED AND DEFLATED NORMALLY AS PER THE DIRECTIONS FOR USE. 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 FURTHER REPORTED THAT THE PATIENT PRESENTED WITH HYPOTENSION DURING THE PROCEDURE AND WAS TREATED WITH DOPAMINE.

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE ANALYSIS COMPLETED (B)(6) 2011. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT FAILED TO DEPLOY. THE 60% STENOSED LESION BEING TREATED WAS LOCATED IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS OBTUSE MARGINAL ARTERY BYPASS GRAFT. THE PHYSICIAN PRE-DILATED THEN ADVANCED THE 4X8MM PROMUS ELEMENT STENT DELIVERY SYSTEM TO THE TARGET LESION AND INFLATED THE DEVICE 30 SECONDS AT 12ATMS, HOWEVER THE DEVICE FAILED TO DEPLOY. THE PHYSICIAN RE-INFLATED TO 12 ATMS AND AGAIN THE DEVICE FAILED TO DEPLOY. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911308400 14059200

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR GUIDE CATHETER: RUNWAY FL 4| GRAPHIX GUIDEWIRE