BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2810117 · Received October 31, 2012

    Report

    Report Number
    2134265-2012-06469
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND VISUAL AND MICROSCOPIC EXAMINATION FOUND STENT DAMAGE. ONE STRUT OF THE MOST PROXIMAL ROW WAS BENT OUTWARDS AND THE STRUTS ON THE FIVE MOST DISTAL ROWS WERE MISALIGNED, STRETCHED AND BENT OUTWARDS. THE STENT HAD MOVED 3MM DISTALLY THEREBY COVERING THE DISTAL MARKERBAND. THE OUTER LUMEN WAS KINKED JUST PROXIMAL TO THE PROXIMAL BALLOON BOND AND THE MIDSHAFT AND COREWIRE WERE BOTH BENT JUST PROXIMAL TO THE PORT BOND. THE PORT WAS TORN SLIGHTLY POTENTIALLY CAUSED DURING REMOVAL OF THE DEVICE FROM THE GUIDE WIRE. THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. TRACES OF BLOOD WERE VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE BALLOON SURFACE INDICATING THE DEVICE WAS USED IN VIVO. 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 PREPARATION FOR A STENTING TREATMENT PROCEDURE, A STENT DAMAGE WAS NOTED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED PRIOR TO USING THIS 3.00 X 16MM PROMUS ELEMENT, MR STENT. WHEN THEY REMOVED THE STENT PROTECTOR, THEY NOTICED THAT THE STENT WAS LIFTED "A LITTLE." THEY DECIDED TO USE THE PROMUS ELEMENT STENT AND ADVANCED THE DEVICE BUT IT WOULD NOT CROSS THE LESION. THE DEVICE WAS REMOVED INTACT FROM INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, A STENT DAMAGE WAS NOTED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED PRIOR TO USING THIS 3.00 X 16 MM PROMUS ELEMENT, MR STENT. WHEN THEY REMOVED THE STENT PROTECTOR, THEY NOTICED THAT THE STENT WAS LIFTED "A LITTLE". THEY DECIDED TO USE THE PROMUS ELEMENT STENT AND ADVANCED THE DEVICE, BUT IT WOULD NOT CROSS THE LESION. THE DEVICE WAS REMOVED INTACT FROM INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316300 14990888

    Patients

    Seq Age Sex Outcome Treatment
    1