BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2840844 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07025
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 MFR#: 2134265-2012-07026, 2134265-2012-07355. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT POSITIONING ISSUE OR STENT MIGRATION OCCURRED. THE 80-95% STENOSED, 25-30MM IN LENGTH, CONCENTRIC, DIFFUSE LESION BEING TREATED CONTAINED A <=45 DEGREE BEND AND WAS LOCATED IN THE MILDLY TORTUOUS, NON-CALCIFIED MID-DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 2.0X8MM APEX BALLOON, INFLATED TO 2-3ATM FOR 20 SECONDS IN THE DISTAL LAD AND 4ATM FOR 30 SECONDS IN THE MID LAD. ADDITIONAL PREDILATATION WAS PERFORMED WITH A 2.0X20MM APEX BALLOON, INFLATED TO 2ATM FOR 60 SECONDS. AN EXTENSIVE SPIRAL DISSECTION OF LAD OCCURRED AFTER PREDILATATION WITH THE 2.0X8MM APEX BALLOON. THE PHYSICIAN IMPLANTED A 2.5X32MM PROMUS ELEMENT PLUS IN THE MID LAD. HAZINESS WAS NOTED PROXIMAL TO THE STENT. A 2.25X32MM PROMUS ELEMENT PLUS STENT WAS IMPLANTED IN THE DISTAL LAD OVERLAPPING THE 2.5X32MM STENT. AFTER DEPLOYMENT, THERE APPEARED TO BE A GAP BETWEEN THE TWO STENTS. THE PHYSICIAN FELT THE GAP APPEARING AFTER DEPLOYMENT COULD BE DUE TO MIGRATION OR LONGITUDINAL COMPRESSION. THERE ALSO APPEARED TO BE SOME DISRUPTION DISTAL TO MOST DISTAL STENT. HOWEVER, STENT DAMAGE WAS NOT IDENTIFIED. A PROXIMAL STENT DISSECTION FLAP WAS NOTED WHICH WAS SEEN WITH IVUS. A 3.0X12MM PROMUS ELEMENT PLUS STENT WAS DEPLOYED IN THIS AREA. A 2.75X8MM PROMUS ELEMENT PLUS STENT WAS DEPLOYED BETWEEN THE 2.5X32MM AND 2.25X32MM STENTS, INFLATED TO 12ATM FOR 20 SECONDS. THE STENTS WERE POST DILATED USING 2.75X20MM NC QUANTUM INFLATED TO 6-14ATM FOR 20-30 SECONDS IN THE MID LAD AND USING A 2.75X8MM NC QUANTUM APEX INFLATED TO 12ATM FOR 20 SECONDS BETWEEN THE DISTAL AND MID STENTS. THE PROXIMAL 3.0X12MM STENT WAS NOT POST DILATED. IVUS WAS PERFORMED AFTER POST DILATION. THE STENTS WERE WELL APPOSED, 0% RESIDUAL, AND HAD TIMI 3 FLOW. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911432220 15286069

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention