BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2160561 · Received July 6, 2011

    Report

    Report Number
    9612164-2011-00675
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    March 31, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (MYOCARDIAL INFARCTION).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT APPROXIMATELY 34 MONTHS POST INDEX PROCEDURE, THE PATIENT UNDERWENT RE-PTCA OF THE TARGET LESION. IT IS REPORTED THAT THE PATIENT WAS TREATED WITH OTHER DES. THE OUTCOME IS REPORTED AS SUCCESSFUL.

    Description of Event or Problem · 1

    APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED AN MI. IT IS UNKNOWN WHETHER THE REPORTED MI WAS RELATED TO THE TARGET VESSEL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT INVESTIGATOR ASSESSED THAT THE REVASCULARIZATION THAT WAS CARRIED OUT 34 MONTHS POST INDEX PROCEDURE TO BE DEFINITELY RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE PROX LAD. THE DAY AFTER THE INDEX PROCEDURE, IT IS REPORTED THAT A MI OCCURRED. IT IS UNKNOWN WHETHER THE REPORTED MI IS RELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND NA 0002379220

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R ASA AND| PATIENT WAS TAKING BETA-BLOCKERS| LIPID LOWERING DRUG| NITRATE| CLOPIDOGREL AT TIME OF EVENT