BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3021450 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01698
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED STENT DAMAGE. THE STENT HAD MOVED DISTALLY ON THE BALLOON BY 27MM AND WAS SITTING ON THE TIP OF THE DEVICE. THE STENT WAS STRETCHED AND DAMAGED ALONG ITS LENGTH. THE BALLOON WAS FOUND TO HAVE THE STENT IMPRESSIONS ON IT AND PILLOWING OF THE BALLOON INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. THE BALLOON OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THERE WAS NO DAMAGE NOTED TO THE TIP OF THE DEVICE. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE HYPOTUBE HAD KINKED APPROXIMATELY 140MM AND 470MM DISTAL FROM THE CATHETER'S STRAIN RELIEF. SEVERAL OTHER KINKS WERE NOTICED ALONG THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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 DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGMENT OCCURRED. USING THE FEMORAL APPROACH, THE PROCEDURE TREATED THE CONCENTRIC TARGET LESION LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT CIRCUMFLEX ARTERY. THERE WAS A SIGNIFICANT BEND IN THE LESION THAT WAS LESS THEN A 45 DEGREE. AFTER PRE-DILATION, A 3.5X28MM PROMUS ELEMENT STENT WAS ADVANCED FOR TREATMENT WITH RESISTANCE AND THE STENT DISLODGED AT A POINT PROXIMAL OF THE TARGET LESION. "THE ENTIRE STENT DELIVERY SYSTEM WAS PULLED BACK SMOOTHLY" TO SUCCESSFULLY REMOVE THE STENT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGMENT OCCURRED. USING THE FEMORAL APPROACH, THE PROCEDURE TREATED THE CONCENTRIC TARGET LESION LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT CIRCUMFLEX ARTERY. THERE WAS A SIGNIFICANT BEND IN THE LESION THAT WAS LESS THEN A 45°. AFTER PRE-DILATION, A 3.5X28MM PROMUS ELEMENT STENT WAS ADVANCED FOR TREATMENT WITH RESISTANCE AND THE STENT DISLODGED AT A POINT PROXIMAL OF THE TARGET LESION. "THE ENTIRE STENT DELIVERY SYSTEM WAS PULLED BACK SMOOTHLY" TO SUCCESSFULLY REMOVE THE STENT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123098 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328350 0015080702

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other