BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2160559 · Received July 6, 2011

    Report

    Report Number
    9612164-2011-00673
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 16, 2011
    Report Date
    June 8, 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). RESULTS: (OCCLUSION/THROMBUS, TVR).

    Description of Event or Problem · 1

    PATIENT RECEIVED A 2.5MM DIAMETER X 12MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN THE 1ST OM DURING INDEX PROCEDURE, WITH NO ISSUES REPORTED. DURING THE PROCEDURE, THE PATIENT ALSO RECEIVED 2 ENDEAVOR SPRINT RX STENTS IN THE DISTAL LCX. IT WAS REPORTED THAT APPROXIMATELY 10 MONTHS POST IMPLANT, THE PATIENT PRESENTED WITH SYMPTOMS. NITRO WAS ADMINISTERED AND THE SYMPTOMS IMPROVED. IT WAS REPORTED THAT ONE MONTH LATER, THE PATIENT WAS RE-HOSPITALIZED WITH SYMPTOMS OF EXERTIONAL ANGINA. ANGIO CONFIRMED COMPLETE OCCLUSION OF THE PREVIOUSLY PLACED STENT IN THE 1ST OM AT ITS OSTIUM. FIFTY PERCENT IN-STENT RE-STENOSIS OF THE DISTAL CX WAS ALSO OBSERVED. IN ADDITION, IN-STENT RE-STENOSIS OF THE LAD, AND DE NOVO DISEASE OF THE MID PDA WERE ALSO CONFIRMED. UNSUCCESSFUL PCI WAS ATTEMPTED TO THE 1ST OM (FLUCH OF OCCLUSION). IT IS UNKNOWN IF THIS OCCLUSION WAS A THROMBUS. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED AND WILL CONTINUE MEDICAL MANAGEMENT. INVESTIGATOR REPORTED THAT THE EVENT WAS PROBABLY RELATED TO THE STUDY STENT. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001251254

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DUAL ANTIPLATELET THERAPY