BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2973087 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00826
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED ALONG WITH A SNARE DEVICE AND A 0.015 INCH GUIDEWIRE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE STENT OF THE DEVICE WAS DISLODGED FROM THE BALLOON. THE STENT WAS RETURNED ATTACHED TO THE SNARE AND SITTING ON THE GUIDEWIRE. THE STENT WAS SEVERELY STRETCHED 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 AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2013-01346. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A STENT WAS IMPLANTED IN A LOCATION OTHER THAN INTENDED AND A STENT DISLODGED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) AND LEFT CIRCUMFLEX (LCX) ARTERIES. THE LESION WAS PRE DILATED WITH A 1.5 X 15 MM AND A 2.0 X 15 MM NON BSC BALLOON. THE 2.25 X 24 MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS ADVANCED TO THE MID LAD, BUT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN DEPLOYED THE STENT IN THE PROXIMAL LAD. THEN THE PHYSICIAN IMPLANTED A 2.75 X 24 MM PROMUS ELEMENT PLUS STENT FROM THE LEFT MAIN TRUNK (LMT) TO THE PROXIMAL LAD, AND JAILED THE PROX LCX, BUT NOT OVERLAPPING THE IMPLANTED 2.25 X 24 MM PROMUS ELEMENT PLUS STENT. THE 2.25 X 12 MMM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS ADVANCED TO THE DISTAL OF THE MID LAD, BUT WAS UNABLE TO CROSS THE PREVIOUSLY DEPLOYED STENT, SO THEY DECIDED TO DEPLOY THE STENT AT THE PROXIMAL LCX. THEY DILATED THE STRUT OF THE 2.75 X 24 MM PROMUS ELEMENT PLUS WITH THE 1.5 MM NON BSC BALLOON, AND TRIED TO ADVANCE THE 2.25 X 12 MMM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM TO THE PROX LCX. THE TIP OF THE DEVICE CAME INTO CONTACT WITH THE PREVIOUSLY DEPLOYED STENT AND THEY WERE UNABLE TO ADVANCE THE 2.25 X 12 MMM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM TO THE PROX LCX. THE 2.25 X 12 MMM PROMUS ELEMENT PLUS STENT WAS DETACHED INSIDE THE PATIENT DURING THE SEVERAL ATTEMPTS TO CROSS THE LESION. THEY RETRIEVED THE 2.25 X 12 MMM PROMUS ELEMENT PLUS STENT WITH THE SNARE AND DILATED PROX LCX WITH THE BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#2134265-2013-01346. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A STENT WAS IMPLANTED IN A LOCATION OTHER THAN INTENDED AND A STENT DISLODGED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) AND LEFT CIRCUMFLEX (LCX) ARTERIES. THE LESION WAS PRE DILATED WITH A 1.5 X 15MM AND A 2.0 X 15MM NON BSC BALLOON. THE 2.25 X 24MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS ADVANCED TO THE MID LAD, BUT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN DEPLOYED THE STENT IN THE PROXIMAL LAD. THEN THE PHYSICIAN IMPLANTED A 2.75 X 24MM PROMUS ELEMENT PLUS STENT FROM THE LEFT MAIN TRUNK (LMT) TO THE PROXIMAL LAD, AND JAILED THE PROX LCX, BUT NOT OVERLAPPING THE IMPLANTED 2.25 X 24MM PROMUS ELEMENT PLUS STENT. THE 2.25 X 12MMM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS ADVANCED TO THE DISTAL OF THE MID LAD, BUT WAS UNABLE TO CROSS THE PREVIOUSLY DEPLOYED STENT, SO THEY DECIDED TO DEPLOY THE STENT AT THE PROXIMAL LCX. THEY DILATED THE STRUT OF THE 2.75 X 24MM PROMUS ELEMENT PLUS WITH THE 1.5MM NON BSC BALLOON, AND TRIED TO ADVANCE THE 2.25 X 12MMM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM TO THE PROX LCX. THE TIP OF THE DEVICE CAME INTO CONTACT WITH THE PREVIOUSLY DEPLOYED STENT AND THEY WERE UNABLE TO ADVANCE THE 2.25 X 12MMM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM TO THE PROX LCX. THE 2.25 X 12MMM PROMUS ELEMENT PLUS STENT WAS DETACHED INSIDE THE PATIENT DURING THE SEVERAL ATTEMPTS TO CROSS THE LESION. THEY RETRIEVED THE 2.25 X 12MMM PROMUS ELEMENT PLUS STENT WITH THE SNARE AND DILATED PROX LCX WITH THE BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77113 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918412220 15581486

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LAXA 1.5 X 15MM: BALLOON CATHETER| NSE 2.0 X 15MM: BALLOON CATHETER