BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2196442 · Received August 2, 2011

    Report

    Report Number
    9612164-2011-00865
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    May 13, 2010
    Report Date
    July 5, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (STENT THROMBOSIS, REVASCULARIZATION).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PROCEDURE CARRIED OUT APPROXIMATELY 3 WEEKS POST INDEX PROCEDURE WAS A STAGED PROCEDURE NOT A REVASCULARIZATION AS PREVIOUSLY REPORTED. IT HAS BEEN REPORTED THAT THERE WAS ONE ENDEAVOR SPRINT RX STENT IMPLANTED IN THE POSTEROLATERAL, ONE ENDEAVOR SPRINT RX STENT IMPLANTED IN THE MID LCX AND TWO ENDEAVOR SPRINT RX STENTS IMPLANTED IN THE 1ST OBTUSE MARGINAL BRANCH DURING THE STAGED PROCEDURE APPROXIMATELY 3 WEEKS POST INDEX PROCEDURE NOT JUST TWO STENTS IN THE POSTEROLATERAL AND ONE STENT IN THE MID LCX AS PREVIOUSLY REPORTED REF MFR REPORT NUMBERS 96122164-2011-01309, 2953200-2011-00208-2, 2953200-2011-00209-2, 2953200-2011-00210-2, 2953200-2011-00211-2, 2953200-2011-00212-2, 9612164-2011-00865-1, AND 9612164-2011-00866-1.

    Description of Event or Problem · 1

    THERE WERE 4 ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS IMPLANTED DURING THE INDEX PROCEDURE, ONE IN THE PROXIMAL LAD, TWO IN THE MID LAD AND ONE IN THE DISTAL LAD. THERE WAS A REVASCULARIZATION CARRIED OUT APPROXIMATELY 3 WEEKS POST INDEX PROCEDURE AND THE PATIENT HAD TWO ADDITIONAL ENDEAVOR SPRINT RX STENTS IMPLANTED IN THE 1ST LEFT POSTEROLATERAL BRANCH AND 1 ADDITIONAL ENDEAVOR SPRINT RX STENT IMPLANTED IN THE MID LCX. PATIENT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 1 MONTH AND 3 MONTH FOLLOW UP'S. IT IS REPORTED THAT THE PATIENT SUFFERED WITH CORONARY ARTERY STENOSIS APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT SUFFERED STENT THROMBOSIS OF THE LIMA TO MID LCX, DIAGNOSTIC ANGIOGRAPHY WAS CARRIED OUT AND THERE WAS A REVASCULARIZATION CARRIED OUT. IT IS REPORTED THAT THERE WAS A CABG REVASCULARIZATION PRESUMABLY RELATED TO THE TARGET VESSEL CARRIED OUT APPROXIMATELY 8 MONTH POST INDEX PROCEDURE. THE PATIENT WAS HOSPITALIZED FOR APPROXIMATELY 2 WEEKS BUT RECOVERED WITH TREATMENT. IN THE OPINION OF THE INVESTIGATOR, THE EVENT WAS RELATED TO THE STUDY DEVICE BUT NOT RELATED TO THE STUDY PROCEDURE. PATIENT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 1 YEAR AND 1.5 YEAR FOLLOW UPS. (REF MFR #'S 2953200201100208-1, 29532002011-00209-1, 29532002011-00210-1, 2953200201100211-1, 2953200201100212-1 & 9612164201100866).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention