BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2010963 · Received March 4, 2011

    Report

    Report Number
    9612164-2011-00014
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    August 4, 2009
    Report Date
    February 12, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (GI BLEED, DISSECTION).

    Description of Event or Problem · 1

    DURING THE PREVIOUSLY REPORTED GI BLEED ASA AND PLAVIX WERE WITHHELD. THE INVESTIGATOR HAS INDICATED THE BLEED WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    PT HAD TWO ENDEAVOR SPRINT RX DRUG-ELUTING STENTS IMPLANTED; ONE TO THE DISTAL RCA AND ONE TO THE PROX RCA. IT WAS REPORTED THAT THE PT SUFFERED ATRIAL FIBRILLATION ON THE SAME DAY. THIS EVENT WAS REPORTED TO HAVE NO RELATION TO THE STUDY DEVICE BUT A PROBABLE RELATION TO THE STUDY PROCEDURE. THE PT IS SAID TO HAVE RECOVERED WITHOUT TREATMENT. A CORONARY ARTERY DISSECTION ALSO OCCURRED ON THE SAME DAY. IT WAS REPORTED THAT "DURING PLACEMENT OF STENT, A MILD DISSECTION OCCURRED REQUIRING AN ADD'L STENT. THIS EVENT WAS REPORTED TO HAVE NO RELATION TO THE STUDY DEVICE BUT A DEFINITE RELATION TO THE STUDY PROCEDURE. THE PT IS SAID TO HAVE RECOVERED WITH TREATMENT. APPROX 13 MONTHS LATER, ATRIAL FIBRILLATION OCCURRED. IT WAS REPORTED THAT THE PT "WAS ADMITTED WITH SYMPTOMATIC ANEMIA, HGB 6.4, TRANSFUSED 2 UNITS PRBC'S. FOUND TO HAVE A-FIB WITH RVR DURING HOSPITALIZATION, SPONTANEOUSLY CONVERTED TO NSR. STARTED ON BB FOR RATE CONTROL". PT WAS REPORTED TO HAVE ANEMIA ON THIS DAY ALSO. THE INVESTIGATOR REPORTS THAT A COLONOSCOPY DEMONSTRATED SEVERE DIVERTICULOSIS. THE PT RECOVERED WITH TREATMENT. (REF MFR #9612164-2011-00015).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R PT ON ASPIRIN| CLOPIDOGREL PRIOR TO EVENT.