BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    MDR report key: 2080533 · Received April 22, 2011

    Report

    Report Number
    9612164-2011-00288
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    December 21, 2010
    Report Date
    March 25, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: NO CONCLUSION CAN BE DRAWN. REACTION.

    Description of Event or Problem · 1

    FOLLOWING A MYOCARDIAL INFARCTION APPROXIMATELY 5 MONTHS AGO, A 2.50 MM DIAMETER X 12MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED IN A PT. LATER THE SAME MONTH, THE PT EXPERIENCED SYMPTOMS OF HYPOTENSION, TINGLING AND NUMBNESS IN THE FEET AND LEG, ARRHYTHMIA (TACHYCARDIA) AND CHEST PAIN. THE FOLLOWING MONTH, THE PT WAS RE-ADMITTED TO THE CARDIAC UNIT AND THE STRESS TEST CARRIED OUT WAS NORMAL. TWO MONTHS LATER, THE PT EXPERIENCED INCREASING CHEST PAIN, WITH FREQUENT "STABBING" PAIN IN THE HEART. THE FOLLOWING MONTH, THE PT WENT TO THE ER WITH INCREASING CHEST PAIN AND A PULSE RATE OF 150. CARDIAC ENZYMES WERE NORMAL AT THIS TIME. SEVERAL DAYS LATER, THE PT WAS RE-ADMITTED TO THE CARDIAC UNIT AGAIN WITH INCREASING CHEST PAIN AND AGAIN THE STRESS TEST CARRIED OUT WAS NORMAL AND ALSO THE NUCLEAR SCAN. THE PT IS CURRENTLY UNDER THE CARE OF AN ALLERGIST. THE STENT DELIVERY SYSTEM WAS NOT RETURNED FOR EVAL. NO ADD'L CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 002833271

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O PLAVIX| METANX| PHENERGAN| ALTACE| METOPROLOL| TRAMADOL| LOVAZA| NITROSTAT| ASPIRIN