BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3020524 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01686
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    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

    UPDATED: CONTACT OFFICE NAME, DEVICE EVALUATED BY MFR, EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES. DEVICE EVALUATION: VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED INSIDE THE GUIDING CATHETER WITH A GUIDEWIRE IN THE LUMEN OF THE DEVICE. NO STENT WAS RECEIVED FOR REVIEW. MICROSCOPIC EXAMINATION OF THE BALLOON FOUND THAT IT HAD BEEN INFLATED AND NOW APPEARED FULLY DEFLATED. THERE WAS A CONSIDERABLE QUANTITY OF CONTRAST MEDIA INSIDE THE INFLATION LUMEN AND BALLOON. MICROSCOPIC ANALYSIS OF THE BALLOON FOUND NO EVIDENCE OF DAMAGE PRESENT. SEVERAL ATTEMPTS WERE MADE TO INFLATE THE BALLOON BUT ALL ATTEMPTS FAILED DUE TO THE CONDITION OF THE RETURNED UNIT. A FURTHER ATTEMPT WAS MADE TO REMOVE THE SDS FROM THE GUIDE CATHETER HOWEVER THIS ATTEMPT FAILED. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A DEFLATION ISSUE OCCURRED. ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 3X16MM, 75% STENOTIC LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN DEPLOYED A 3.5X16MM PROMUS ELEMENT PLUS STENT. IT WAS THEN OBSERVED THAT THE BALLOON DID NOT DEFLATE PROPERLY. THE PHYSICIAN WAS UNABLE TO GET IT BACK INTO THE GUIDE CATHETER AND IT WAS VERY DIFFICULT WITHDRAWING THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A DEFLATION ISSUE OCCURRED. ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 3X16MM, 75% STENOTIC LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN DEPLOYED A 3.5X16MM PROMUS ELEMENT PLUS STENT. IT WAS THEN OBSERVED THAT THE BALLOON DID NOT DEFLATE PROPERLY. THE PHYSICIAN WAS UNABLE TO GET IT BACK INTO THE GUIDE CATHETER AND IT WAS VERY DIFFICULT WITHDRAWING THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123872 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416350 15698272

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR