BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2120087 · Received June 7, 2011

    Report

    Report Number
    9612164-2011-00527
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    September 4, 2011
    Report Date
    August 8, 2012
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    EVENT DATE FOR PREVIOUSLY REPORTED MI HAS BEEN ADJUDICATED BY CLINICAL EVENTS COMMITTEE (CEC).

    Additional Manufacturer Narrative · 1

    EVENT DATE FOR PREVIOUSLY REPORTED MI HAS BEEN CONFIRMED. EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (HAEMORRHAGE). (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT WAS TAKING ASA AND WARFARIN 24HRS PRIOR TO GI BLEED EVENT.

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS INHERENT RISK OF PROCEDURE (MYOCARDIAL INFRACTION). (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP MDR REPORT FOR ADDITIONAL PATIENT HISTORY DETAILS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    APPROXIMATELY 5 MONTHS POST THE INDEX PROCEDURE THE PATIENT WAS ADMITTED WITH RIGHT SIDE WEAKNESS, ISCHEMIC CVA WITH RIGHT SIDE HEMI PARESIS, PATIENT WAS DISCHARGED TO REHAB UNIT, CONTINUING WITH TREATMENT. APPROXIMATELY 9 MONTHS POST THE INDEX PROCEDURE THE PATIENT PRESENTED WITH NAUSEA, VOMITING, WEAKNESS AND WEIGHT LOSS. PATIENT WAS DIAGNOSED WITH RENAL FAILURE, DURING HOSPITALIZATION PATIENT WAS DIAGNOSED WITH A NEW NON-STEMI DEPRESSION MI. PATIENT WAS STARTED ON HEMODIALYSIS AND GIVEN IV MEDICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT SUFFERED A STROKE APPROXIMATELY 14 MONTHS POST THE INDEX PROCEDURE. THE INVESTIGATOR HAS INDICTED THIS EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE PATIENT RECOVERED WITH TREATMENT.

    Description of Event or Problem · 1

    PATIENT IS REPORTED TO HAVE SUFFERED A GI BLEED APPROXIMATELY 10 MONTHS POST INDEX PROCEDURE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT RECEIVED A BLOOD TRANSFUSION FOLLOWING PREVIOUSLY REPORTED GI BLEED.

    Description of Event or Problem · 1

    THE PATIENT HAD THREE ENDEAVOR SPRINT RX DRUG-ELUTING STENTS IMPLANTED: TWO IN THE PROX LEFT CIRCUMFLEX AND ONE IN THE MID RCA. APPROXIMATELY 5 MONTHS FROM THE INDEX PROCEDURE, THE PATIENT SUFFERED A CEREBROVASCULAR ACCIDENT WHICH REQUIRED HOSPITALIZATION AND THE PATIENT IS CONTINUING WITH TREATMENT. IT WAS NOT ASSESSED WHETHER THE EVENT WAS RELATED TO THE STUDY DEVICE. (REF MFR # 9612164-2011-00528 AND 9612164201100529).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization ASA AND WARFARIN