BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2872044 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07583
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION FOUND NO ISSUES WITH THE EITHER THE STENT OR THE ENTIRE DEVICE. THE CRIMPED STENT, 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 DISTAL EDGE OF THE STENT WAS EXAMINED AND NO VISIBLE EVIDENCE OF DAMAGE WAS FOUND. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE TARGET WAS A LONG DENSELY CALCIFIED LESION AT PROXIMAL TO MIDDLE LEFT ANTERIOR DESCENDING CORONARY ARTERY, WITH 95% OCCLUSION. ROTATIONAL ATHERECTOMY USING A ROTALINK PLUS 1.25MM BURR. AFTER SUCCESSFUL ROTATIONAL ATHERECTOMY, THE PHYSICIAN PREDILATED THE LESION USING A NON-BSC 2.5X15MM BALLOON, THEN SELECTED A PROMUS ELEMENT 2.75X32MM STENT DELIVERY SYSTEM. WHILE ADVANCING THE STENT ACROSS THE LESION, THE PHYSICIAN NOTICED RESISTANCE AT THE PROXIMAL SEGMENT OF THE LESION. AFTER TRYING SEVERAL ATTEMPTS, IT WAS UNABLE TO CROSS THE LESION. AFTER WITHDRAWING THE STENT, PHYSICIAN NOTICED DAMAGE TO THE DISTAL STRUTS OF THE STENT. THE PROCEDURE WAS COMPLETED USING A 2.75MM X 28MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE STATUS OF THE PATIENT IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE TARGET WAS A LONG DENSELY CALCIFIED LESION AT PROXIMAL TO MIDDLE LEFT ANTERIOR DESCENDING CORONARY ARTERY, WITH 95% OCCLUSION. ROTATIONAL ATHERECTOMY USING A ROTALINK PLUS 1.25MM BURR. AFTER SUCCESSFUL ROTATIONAL ATHERECTOMY, THE PHYSICIAN PREDILATED THE LESION USING A NON-BSC 2.5X15MM BALLOON, THEN SELECTED A PROMUS ELEMENT 2.75X32MM STENT DELIVERY SYSTEM. WHILE ADVANCING THE STENT ACROSS THE LESION, THE PHYSICIAN NOTICED RESISTANCE AT THE PROXIMAL SEGMENT OF THE LESION. AFTER TRYING SEVERAL ATTEMPTS, IT WAS UNABLE TO CROSS THE LESION. AFTER WITHDRAWING THE STENT, PHYSICIAN NOTICED DAMAGE TO THE DISTAL STRUTS OF THE STENT. THE PROCEDURE WAS COMPLETED USING A 2.75MM X 28MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE STATUS OF THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332270 0015234795

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR