BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3052210 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02250
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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 PATIENT AS MDR ID 2134265-2013-02251. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE POST DEPLOYMENT OCCURRED. THE LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) WAS PREDILATED WITH AN EMERGE BALLOON CATHETER. THE PHYSICIAN IMPLANTED A PROMUS ELEMENT PLUS 3.5X4MM IN THE LEFT MAIN (LM) / LAD. KISSING BALLOON TECHNIQUE WAS PERFORMED IN THE LM AND CIRCUMFLEX (CX) USING TWO 3.5MM EMERGE BALLOONS. AFTER BALLOON DEFLATION THE PROXIMAL STENT SHORTENED 10MM. SO THE PHYSICIAN HAD TO IMPLANT ANOTHER PROMUS ELEMENT PLUS 3.5X20MM IN THE LM / CX ARTERY. KISSING BALLOON TECHNIQUE WAS AGAIN PERFORMED USING THE SAME TWO 3.5MM EMERGE BALLOON CATHETERS. AFTER BALLOON DEFLATION, THE SECOND PROMUS ELEMENT PLUS SHORTENED ABOUT 5MM IN THE PROXIMAL PART OF THE STENT. NO FURTHER PATIENT COMPLICATIONS OCCURRED AND THE PATIENT'S STATUS IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155013 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918420350 15705576

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention