BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2251317 · Received September 13, 2011

    Report

    Report Number
    9612164-2011-01135
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    July 5, 2011
    Report Date
    May 2, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: GI BLEED. (BASED ON THE INFO PROVIDED NO ROOT CAUSE CAN BE DETERMINED).

    Additional Manufacturer Narrative · 1

    PREVIOUSLY REPORTED BLEED EVENT BEGAN ONE DAY EARLIER THAN PREVIOUSLY REPORTED. PLAVIX WAS STOPPED AS PART OF TREATMENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RX DRUG-ELUTING STENTS WERE SUCCESSFULLY IMPLANTED DURING INDEX PROCEDURE. ONE STENT (3.50 X 18MM) WAS IMPLANTED TO PROXIMAL RCA; ONE STENT (3.50 X 30MM) WAS IMPLANTED TO MID RCA. PT WAS SYMPTOMATIC/FREE OF SYMPTOMS AT 30 DAY, 6 AND 9 MONTH FOLLOW UP. A DIVERTICULAR BLEED WAS REPORTED TO HAVE OCCURRED APPROXIMATELY 11 MONTHS FOLLOWING INDEX PROCEDURE, WHICH LASTED TWO DAYS. PT RECEIVED A BLOOD INFUSION. THE PT HAD ANOTHER BLEED EVENT TWO WEEKS LATER AND A FURTHER BLEED EVENT A WEEK LATER, MEDICAL TREATMENT WAS NOT NECESSARY. INVESTIGATOR HAD INDICATED THAT THE EVENTS WERE NOT RELATED TO THE STUDY PROCEDURES. THE PT IS IN REMISSION. (REF MFR# 9612164201101136).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention