BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2141087 · Received June 21, 2011

    Report

    Report Number
    9612164-2011-00617
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    January 11, 2011
    Report Date
    May 26, 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT IS REPORTED TO HAVE SUFFERED A GI BLEED APPROXIMATELY 9 MONTHS POST STENT IMPLANT. INTERVENTION WAS PERFORMED IN THE FORM OF AN UPPER GI SERIES, COLONOSCOPY, TRANSFUSIONS AND AN ABD. PATIENT IS REPORTED TO HAVE RECOVERED WITH TREATMENT. THE INVESTIGATOR REPORTS THAT THERE IS NO RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT/ PROCEDURE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT ALSO SUFFERED AN ACUTE MI APPROXIMATELY 9 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT EXPERIENCED AN ML DURING HOSPITAL STAY FOR UPPER GI BLEED. IT IS REPORTED THAT IT WAS A Q-WAVE MI, LOCATED IN THE ANTERIOR, INVOLVING THE TARGET LESION. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. IT IS REPORTED THAT ELEVATED TROPONINS WERE NOTED IN LAB WORK. ANGIOGRAM REVEALED TRIPLE VESSEL DISEASE WHICH WAS TREATED MEDICALLY.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE 1ST DIAGONAL. PATIENT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 30 DAY, 6 MONTH AND 1 YEAR FOLLOW-UP. APPROXIMATELY 16 MONTHS POST INDEX PROCEDURE, IT IS REPORTED THAT THE PATIENT SUFFERED AN MI AND WAS HOSPITALIZED. PATIENT HAD AN ECHOCARDIOGRAM, AN ADENOSIN STRESS TEST AND A MYOCARDIAL PERFUSION. TYPE OF MI WAS ASSESSED TO BE AN ACUTE NON-STEMI (NON Q-WAVE). THE LOCATION OF THE INFARCTION WAS NON DETERMINABLE. THE INVESTIGATOR ASSESSED THAT THERE WAS NO RELATIONSHIP BETWEEN THE EVENT AND THE STUDY DEVICE OR THE STUDY PROCEDURE. THE PATIENT RECOVERED WITH TREATMENT AND NO OTHER CLINICAL SEQUELAE WERE REPORTED. PATIENT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 1.5 YEAR FOLLOW-UP.

    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 65 YR Female Required Intervention CLOPIDOGREL| ASPIRIN