BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2201840 · Received August 5, 2011

    Report

    Report Number
    9612164-2011-00879
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    January 25, 2011
    Report Date
    April 26, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS - INHERENT RISK OF PROCEDURE (MYOCARDIAL INFARCTION).

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ROOT CAUSE OF STROKE UNK); (CVA/STROKE).

    Description of Event or Problem · 1

    ECG CHECK PERFORMED ONE DAY PRIOR TO THE INDEX PROCEDURE CONFIRMED THERE WERE NO ABNORMALITIES. ON THE DAY OF THE INDEX PROCEDURE, UNFRACTIONATED HEPARIN WAS DOSED. TWO ENDEAVOR SPRINT CORONARY DRUG-ELUTING STENTS WERE DEPLOYED IN THE LEFT MAIN AND PROXIMAL/MID LCX, WHICH RESULTED IN 0% STENOSIS. IVUS CHECK CONFIRMED COMPLETE STENT APPOSITION TO THE VESSEL WALL. FOUR DAYS POST INDEX PROCEDURE, PARALYSIS OF THE RIGHT SIDE OF THE BODY AND DEFECT IN SPEECH WAS OBSERVED. A CONSULTATION WITH DEPARTMENT OF NEUROLOGY WAS PERFORMED. THROMBOLYTIC THERAPY (T-PA DOSE) WAS PERFORMED. AFTER THE MEDICATION, NEUROLOGICAL SYMPTOMS WERE SLIGHTLY IMPROVED. ONE DAY LATER, CT/MRI REVEALED THE WIDESPREAD INFARCTION OF LEFT MCA REGION AND ACA. FLOW OF THE LEFT MCA WAS OBSERVED, BUT STENOSIS WAS CONFIRMED ON THE BASE. GLYCEOL WAS DOSED AS A PRECAUTION FOR BRAIN EDEMA. AS THE PT SUFFERED FROM WIDESPREAD INFARCTION AND WAS TAKING DAPT, HEPARIN WAS NOT DOSED. THE FOLLOWING DAY, THE PT WAS TRANSFERRED TO DEPARTMENT OF NEUROLOGY. TWO WEEKS LATER, A FEVER WAS OBSERVED (39-40 DEGREES). A URINARY TRACT INFECTION WAS SUSPECTED AND ANTIBIOTICS WERE ADMINISTERED. THE PT WAS DISCHARGED ONE MONTH LATER. REFERENCE MFR REPORT NUMBER 9612164-2011-00878.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED A MYOCARDIAL INFARCTION ON THE SAME DAY AS INDEX PROCEDURE. INVESTIGATOR REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT. REFERENCE MFR REPORT NUMBER 9612164201100878 <(>&<)> 9612164201100879.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention ASA| CLOPIDOGREL