BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 4992719 · Received August 11, 2015

    Report

    Report Number
    2134265-2015-05315
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 18, 2015
    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.: THE STENT DELIVERY SYSTEM WAS RECEIVED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT WAS DAMAGED. IT WAS NOTED THAT THE STENT STRUTS AT THE CENTER OF THE STENT WERE SEVERELY STRETCHED AND BUNCHED AT THE DISTAL END. THIS DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE OR AN OBSTRUCTION DURING THE WITHDRAWAL OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION FOUND NO KINKS OR DAMAGE ALONG THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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 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 STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.00X28MM PROMUS ELEMENT STENT WAS ADVANCED TO TREAT THE TARGET LESION. THE PHYSICIAN WANTED TO REPOSITION THE STENT; HOWEVER, WHILE RETRIEVING THE DEVICE BACK, THE DISTAL STRUT OF THE STENT BECAME DISTORTED. THE PROCEDURE WAS COMPLETED WITH A 3X24MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.00X28MM PROMUS ELEMENT STENT WAS ADVANCED TO TREAT THE TARGET LESION. THE PHYSICIAN WANTED TO REPOSITION THE STENT; HOWEVER, WHILE RETRIEVING THE DEVICE BACK, THE DISTAL STRUT OF THE STENT BECAME DISTORTED. THE PROCEDURE WAS COMPLETED WITH A 3X24MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526887 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328300 17736529

    Patients

    Seq Age Sex Outcome Treatment
    1