BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿ LONG

    MDR report key: 2962126 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00751
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 20, 2013
    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 IDENTIFIED SEVERE KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. 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 BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. 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

    (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).

    Description of Event or Problem · 1

    SAME CASE AS MDR 2134265-2013-00751. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE REMOVAL DIFFICULTIES OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 3.0X32MM, CONCENTRIC, DE NOVO, 95% STENOSED LESION BEING TREATED WAS LOCATED IN THE HIGHLY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). PREDILATION WAS PERFORMED WITH A 2.0X15MM NON-BSC BALLOON CATHETER. THE PHYSICIAN THEN ADVANCED A 2.5X38MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION; HOWEVER, THE SDS BECAME STUCK. UPON REMOVAL THE PROXIMAL END OF THE SHAFT BECAME KINKED. THE PHYSICIAN THEN ADVANCED A 2.75X38MM PROMUS ELEMENT SDS TO THE TARGET LESION HOWEVER THE SDS BECAME STUCK. UPON REMOVAL THE PROXIMAL END OF THE SHAFT FRACTURED AT THE HUB. THE PROCEDURE WAS COMPLETED BY IMPLANTING 3.0X16MM AND 3.0X20MM PROMUS ELEMENT STENTS IN THE LAD. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR 2134265-2013-00751. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE REMOVAL DIFFICULTIES OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 3.0X32MM, CONCENTRIC, DE NOVO, 95% STENOSED LESION BEING TREATED WAS LOCATED IN THE HIGHLY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). PREDILATION WAS PERFORMED WITH A 2.0X15MM NON-BSC BALLOON CATHETER. THE PHYSICIAN THEN ADVANCED A 2.5X38MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION HOWEVER THE SDS BECAME STUCK. UPON REMOVAL THE PROXIMAL END OF THE SHAFT BECAME KINKED. THE PHYSICIAN THEN ADVANCED A 2.75X38MM PROMUS ELEMENT SDS TO THE TARGET LESION HOWEVER THE SDS BECAME STUCK. UPON REMOVAL THE PROXIMAL END OF THE SHAFT FRACTURED AT THE HUB. THE PROCEDURE WAS COMPLETED BY IMPLANTING 3.0X16MM AND 3.0X20MM PROMUS ELEMENT STENTS IN THE LAD. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65018 PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338270 15300430

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR