BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿ LONG

    MDR report key: 2901938 · Received January 8, 2013

    Report

    Report Number
    2134265-2012-08243
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - INITIAL VISUAL EXAMINATION NOTED THAT THE DEVICE WAS RETURNED IN TWO SECTIONS, AS A RESULT OF A BREAK IN THE HYPOTUBE. THE PROXIMAL CATHETER SECTION INCLUDES THE MANIFOLD AND MEASURES 237 MM FROM THE DISTAL END OF THE STRAIN RELIEF. THE DISTAL SECTION MEASURES 123 CM IN TOTAL. THE HYPOTUBE IS SEVERELY KINKED BOTH PROXIMAL AND DISTAL TO THE BREAK POINT. THE STENT IS ALSO DAMAGED AS SEVERAL STRUTS ON THE 9TH AND 10TH STRUT ROWS ARE MISALIGNED AND FOLDED OUTWARDS. THE LUMEN WAS STRETCHED FOR 4 MM JUST DISTAL TO THE PORT BOND. NO FURTHER DAMAGE WAS NOTED ON THE RETURNED DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A SHAFT FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% STENOSED , DE NOVO, TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. A 1.5X14MM NON-BSC BALLOON WAS ADVANCED FOR PRE-DILATION AND SIGNIFICANT RESISTANCE WHILE CROSSING THE LESION WAS ENCOUNTERED. THE STENOSIS AS REDUCED TO 50% AND A SMALL DISSECTION WAS NOTED FOLLOWING BALLOON DILATION. THE 3.0X38MM PROMUS ELEMENT WAS ADVANCED TO THE DISSECTED LESION HOWEVER WAS UNABLE TO CROSS THE LESION. SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE DEVICE AND THE SHAFT OF THE STENT DELIVERY SYSTEM (SDS) WAS BROKEN. THE SDS WAS REMOVED INTACT WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH A 2.0X15MM MAVERICK BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A SHAFT FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% STENOSED , DE NOVO, TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. A 1.5X14MM NON-BSC BALLOON WAS ADVANCED FOR PRE-DILATION AND SIGNIFICANT RESISTANCE WHILE CROSSING THE LESION WAS ENCOUNTERED. THE STENOSIS AS REDUCED TO 50% AND A SMALL DISSECTION WAS NOTED FOLLOWING BALLOON DILATION. THE 3.0X38MM PROMUS ELEMENT WAS ADVANCED TO THE DISSECTED LESION HOWEVER WAS UNABLE TO CROSS THE LESION. SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE DEVICE AND THE SHAFT OF THE STENT DELIVERY SYSTEM (SDS) WAS BROKEN. THE SDS WAS REMOVED INTACT WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH A 2.0X15MM MAVERICK BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10005 PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338300 14673424

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR BALLOON CATHETER: AVION 1.5X14MM