BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    MDR report key: 2181127 · Received July 21, 2011

    Report

    Report Number
    9612164-2011-00812
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    March 22, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (TVR/HEMORRHAGE). CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE PATIENT HAD TWO ENDEAVOR SPRINT OVER-THE-WIRE (OTW) DRUG-ELUTING STENTS IMPLANTED DURING THE INDEX PROCEDURE IN THE DISTAL LAD. APPROXIMATELY 2 WEEKS FROM INDEX PROCEDURE, THE PATIENT UNDERWENT PCI AFTER COMPLAINING OF RECURRENT ANGINA. THE PATIENT HAD AN ENDEAVOR SPRINT OTW DRUG ELUTING STENT IMPLANTED IN THE 1ST DIAGONAL BRANCH DURING THE PCI. THE PATIENT RECOVERED WITH TREATMENT. IT WAS REPORTED THAT THE PCI HAD NO RELATIONSHIP TO THE STUDY DEVICE. APPROXIMATELY 1 YEAR AND 6 MONTHS FROM INDEX PROCEDURE, THE PATIENT SUFFERED FROM AN EPISODE OF COLITIS WITH BLEEDING (GI BLEED) AND WAS ADMITTED TO HOSPITAL. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND RECOVERED WITH TREATMENT. IT WAS REPORTED THAT THE GI BLEED WAS SPONTANEOUS AND HAD NO RELATIONSHIP TO THE STUDY DEVICE. PATIENT WAS TAKING STUDY MEDICATION AT TIME OF EVENT. (REF MFR # 9612164-2011-00813 AND 9612164-2011-00814).

    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 71 YR Required Intervention