BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2378630 · Received December 16, 2011

    Report

    Report Number
    9612164-2011-01704
    Event Type
    Injury
    Date Received
    December 16, 2011
    Date of Event
    October 1, 2011
    Report Date
    December 2, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: (B)(4) INHERENT RISK OF PROCEDURE (GI BLEED), (B)(4). MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF ONE ENDEAVOR SPRINT DRUG-ELUTING STENT TO RIGHT POSTERIOR DESCENDING ARTERY, ONE ENDEAVOR SPRINT DRUG ELUTING STENT TO DISTAL RIGHT CORONARY ARTERY AND ONE DRUG ELUTING STENT TO MID RIGHT CORONARY ARTERY. RESIDUAL STENOSIS WAS 0 % WITH TIMI 3 FLOW. APPROXIMATELY 1 YEAR AND 2 MONTHS FROM THE INDEX PROCEDURE, THE PATIENT WAS PRESENTED TO THE HOSPITAL WITH THE COMPLAINT OF BRIGHT RED BLOOD PER RECTUM. THE PATIENT WAS REPORTED TO HAVE HAD A COLONOSCOPY PERFORMED WHICH WAS REPORTED TO REVEAL CECAL POLYP. INTERNAL HEMORRHOIDS WERE SUSPECTED AS THE CAUSE OF BRIGHT RED BLOOD. THE PATIENT WAS REPORTED TO HAVE RECEIVED ONE UNIT OF PACKED RED CELLS WHILE HOSPITALIZATION. THE EVENT WAS CONSIDERED RECOVERED OR RESOLVED. ON DATE, THE PATIENT WAS DISCHARGED. THE EVENT OF BRIGHT RED BLOOD PER RECTUM WAS CONSIDERED AN EVENT THAT REQUIRED INITIAL OR PROLONGED HOSPITALIZATION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT AND HAS BEEN REQUESTED. IN THE INVESTIGATOR'S OPINION, THE EVENT OF BRIGHT RED BLOOD PER RECTUM WAS CONSIDERED MODERATE IN INTENSITY, NOT RELATED TO THE STUDY DRUG, NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. REF 9612164-2011-01704, 9612164-2011-01705, 9612164-2011-01706

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0001407447

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention CLOPIDOGREL