BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    MDR report key: 2160465 · Received July 5, 2011

    Report

    Report Number
    9612164-2011-00665
    Event Type
    Injury
    Date Received
    July 5, 2011
    Date of Event
    December 5, 2010
    Report Date
    August 22, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (MI, STENT THROMBOSIS, REVASCULARIZATION).

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT OVER THE WIRE (OTW) DRUG ELUTING STENTS WERE IMPLANTED DURING THE INDEX PROCEDURE; ONE IN THE MID RCA AND ONE IN THE PROXIMAL RCA. AT 30 DAY F/U, PATIENT'S WORST ANGINA STATUS WAS REPORTED AS III PER THE CANADIAN CARDIOVASCULAR SOCIETY CLASSIFICATION (CCSC) OF ANGINA. APPROX 2 WEEKS AFTER THE INDEX PROCEDURE, THE PT PRESENTED TO ANOTHER HOSP WITH CHEST PAIN, PT WAS TRANSFERRED BY AIR FLIGHT AND WAS FOUND TO BE HAVING AN ACUTE STEMI. THE PREVIOUSLY PLACED STENT IN THE MID RCA WAS FOUND TO BE THROMBOLYTIC. IN THE INVESTIGATOR'S OPINION THE STENT THROMBOSIS EVENT WAS SEVERE IN INTENSITY, DEFINITELY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE STUDY PROCEDURE AND DRUG. IT IS REPORTED THAT THE ACUTE STEMI WAS A NON-Q-WAVE MI, LOCATED IN THE POSTERIOR, INFERIOR INVOLVING THE TARGET LESION. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. IT IS REPORTED THAT THERE WAS A BALLOON ONLY REVASCULARIZATION OF THE MID RCA CARRIED OUT ON THE SAME DAY. PT WAS TAKING STUDY MEDICATIONS AT THE TIME OF THE EVENT. AT 3 MONTHS F/U, PT'S WORST ANGINA STATUS WAS REPORTED AS II PER THE CCSC OF ANGINA. (REFERENCE MFR REPORT NUMBER 2953200-2011-00018).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON PATIENT MEDICATION. INVESTIGATOR HAS INDICATED THAT THE PREVIOUSLY REPORTED MI WAS DEFINITELY RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A THROMBECTOMY WAS PERFORMED AS TREATMENT OF THE PREVIOUSLY REPORTED MI EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention ASA, CLOPIDOGREL