BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2223883 · Received August 18, 2011

    Report

    Report Number
    9612164-2011-00948
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    June 3, 2011
    Report Date
    August 8, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (HAEMORRHAGE).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (HEMORRHAGE REQUIRING TRANSFUSION).

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RX DRUG ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LAD. APPROXIMATELY 6 MONTHS FOLLOWING INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED DUE TO ATRIAL FIBRILLATION. ATENOLOL WAS STOPPED AND AMIODARONE AND CARDIZEM WERE STARTED. THE INVESTIGATOR HAS INDICTED, THE EVENT WAS REMOTELY RELATED TO THE STUDY DEVICE APPROXIMATELY 1 MONTH LATER, THE PATIENT WAS HOSPITALIZED DUE TO SHORTNESS OF BREATH DUE TO COPD EXACERBATION, COLONOSCOPY WITH REMOVAL OF POLYPS WAS CARRIED OUT. THE INVESTIGATOR HAS INDICTED THAT THIS EVENT WAS NOT RELATED TO THE STUDY DEVICE. APPROXIMATELY 2 WEEKS LATER, THE PATIENT WAS HOSPITALIZED DUE TO ABDOMINAL PAIN AND BLEEDING. BOTH BRIGHT AND DARK BLOODY STOOLS WERE NOTED. THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF PRBC. IT WAS REPORTED THAT BLEEDING WAS MOST LIKELY SECONDARY TO RECENT COLON POLYPECTOMY AND CAUTERIZATION OF ULCERS. PROVOCATION OF BLEEDING WAS REPORTED TO BE DUE TO INSTRUMENTATION. ASA WAS HELD. INVESTIGATOR HAS INDICATED THAT EVENT WAS NOT RELATED TO THE STUDY STENT. ONE WEEK LATER, THE PATIENT WAS HOSPITALIZED DUE TO FATIGUE AND REPORTED DARK STOOLS, RECURRENT GI BLEED, OOZING GASTRIC AVM, SMALL ANTRAL ULCER, CHRONIC IRON DEFICIENCY AND B12 ANEMIA. CATHETERIZATION OF THE GASTRIC AVM, A BLOOD TRANSFUSION WITH 4 UNITS OF PRBC, CT OF THE BRAIN AND VIDEO SWALLOW TEST WERE CARRIED OUT. THE INVESTIGATOR HAS INDICATED THAT THIS EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    CLINICAL EVENTS COMMITTEE ADJUDICATED THAT THE PATIENT SUFFERED A GI BLEED APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE. THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF PACKED RED BLOOD CELLS.

    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 81 YR Hospitalization| R CLOPIDOGREL| ASPIRIN