BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2120088 · Received June 7, 2011

    Report

    Report Number
    9612164-2011-00525
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    December 8, 2010
    Report Date
    July 29, 2013
    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: (MI, TVR).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVASCULARIZATION WAS PERFORMED APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE DUE TO ENDEAVOR SPRINT RX SEVERE ISR. INVESTIGATOR REPORTED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY STENT.

    Description of Event or Problem · 1

    PATIENT RECEIVED A 2.5MM DIAMETER X 14MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN THE PROX RCA AND DURING INDEX PROCEDURE WITH NO ISSUE REPORTED. HOWEVER, IT WAS REPORTED THAT APPROXIMATELY 1 MONTH POST IMPLANT, THE PATIENT PRESENTED WITH SYMPTOMS OF NSTEMI. IN STENT RE-STENOSIS WAS CONFIRMED WITHIN THE ENDEAVOR SPRINT RX STENT. POBA AND CARDIAC CATHETERIZATION WITH DEPLOYMENT OF ONE OTHER MANUFACTURER STENT WERE PERFORMED IN THE RCA. IT WAS REPORTED THAT APPROXIMATELY 3.5 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH CHEST PAIN, ANEMIA AND ACUTE RENAL FAILURE. ONE OTHER MANUFACTURER STENT WAS DEPLOYED IN THE LEFT MAIN. POBA WAS PERFORMED IN THE LAD AND RCA. DURING HOSPITALIZATION, THE PATIENT ALSO RECEIVED 2 UNITS PACKED RED BLOOD CELLS. PATIENT HAD RENAL ULTRASOUND AND FOUND NO EVIDENCE OF NEPHROLITHIASIS. PATIENT WAS DISCHARGED IN STABLE CONDITION. INVESTIGATOR REPORTED THAT THE EVENT WAS PROBABLY RELATED TO THE STUDY STENT. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    CEC HAVE ADJUDICATED THAT THE PREVIOUSLY REPORTED MI AT 1 MONTH POST INDEX PROCEDURE WAS RELATED TO THE STUDY DEVICE.CEC HAVE ADJUDICATED THAT THE PREVIOUSLY REPORTED TARGET VESSEL REVASCULARIZATION OF THE RCA APPROXIMATLEY 1 MONTH POST INDEX PROCEDURE WAS NOT RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MI WHICH OCCURRED APPROXIMATELY 3.5 MONTHS POST THE INDEX PROCEDURE WAS PROBABLY RELATED TO THE STUDY STENT AND THE EVENT WAS RESOLVED.

    Description of Event or Problem · 1

    THE PATIENT SUFFERED AN MI APPROXIMATELY 3.5 MONTHS POST INDEX PROCEDURE. THE RELATIONSHIP BETWEEN THE EVENT AND THE STUDY DEVICE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001166567

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention