BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2871818 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07879
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DEFORMATION OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY AND WAS TREATED BY IMPLANTING A 3.50 X 24MM PROMUS ELEMENT PLUS. WHEN THE PHYSICIAN PULLED BACK ON AN UNSPECIFIED SPECIALTY CATHETER, THE CATHETER PULLED BACK ON THE STENT AS WELL CAUSING STENT DEFORMATION NO FURTHER INTERVENTION WAS UNDERTAKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918424350 0015032436

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR GUIDE WIRE: .018 BMW| GUIDE CATHETER: CORDIS 7FR