BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2903594 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08302
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 11, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS 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 REPORT #: 2134265-2012-08264. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DEFORMATION OCCURRED. THE PROCEDURE TREATED THE TARGET LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER PRE-DILATION, TWO OVERLAPPING PROMUS ELEMENT PLUS STENTS [3.0X12MM DISTAL, 3.0X38MM PROXIMAL] WERE ADVANCED AND DEPLOYED IN THE TARGET LESION. NEXT A 3.25X12MM QUANTUM BALLOON WAS ADVANCED TO POST DILATE THE OVERLAP, BUT WAS RESISTANCE WAS FELT AND COMPRESSION OCCURRED AT THE PROXIMAL EDGE OF THE 3.0X12MM PROMUS ELEMENT PLUS STENT AND ALSO AT THE DISTAL EDGE OF THE 3.0X38MM PROMUS ELEMENT PLUS STENT CREATING A GAP BETWEEN THE TWO STENTS. TREATMENT PLACED AN ADDITIONAL OVERLAPPING UNSPECIFIED 3.0X8.0MM STENT BETWEEN THE TWO PREVIOUSLY IMPLANTED STENTS. NO FURTHER PATIENT COMPLICATIONS OCCURRED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11658 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911438300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 3.0X12MM PROMUS ELEMENT PLUS STENT| 3.25X12MM QUANTUM BALLOON CATHETER