BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    MDR report key: 2223878 · Received August 18, 2011

    Report

    Report Number
    9612164-2011-00977
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    June 2, 2011
    Report Date
    July 22, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: EXPIRATION DATE NOT CHECKED. NO DEVICE RECEIVED FOR EVALUATION. EVALUATION, CONCLUSION: EXPIRATION DATE NOT CHECKED.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO TREAT A LESION TO THE FIRST OBTUSE MARGINAL. THE PHYSICIAN IMPLANTED A 2.5 X 14 ENDEAVOR SPRINT OVER THE WIRE STENT. NINE MONTHS POST PROCEDURE, THE PATIENT REPORTED TO HOSPITAL WITH CARDIAC CHEST PAIN. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED ON THE PROXIMAL CIRCUMFLEX CORONARY ARTERY TO OBTUSE MARGINAL AND RIGHT CORONARY ARTERY. THE CHEST PAIN WAS CONSIDERED MODERATE IN INTENSITY AND UNLIKELY TO BE RELATED TO THE STUDY DEVICE. THERE WAS NO PATIENT INJURY REPORTED AND THE PATIENT IS RECOVERING. INVESTIGATION OF THE EVENT REVEALED THAT THE ENDEAVOR SPRINT OVER THE WIRE STENTS WERE IMPLANTED AFTER THE EXPIRATION DATE. REFERENCE MFR REPORT NUMBER 9612164-2011-00978.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001062846

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R