BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2100749 · Received May 18, 2011

    Report

    Report Number
    2953200-2011-01019
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: CVA, HYPERTENSION. LACK OF INFORMATION. CONCLUSION: LACK OF INFORMATION.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 3 MONTHS AGO. VESSEL AND ANEURYSM MORPHOLOGY WAS UNKNOWN. PRIOR TO SURGERY, THE PATIENT REPORTED HEALTHY BLOOD PRESSURE MOST OFTEN ON THE LOWER END OF NORMAL. AFTER THE STENT GRAFT PLACEMENT, THE PATIENT'S BLOOD PRESSURE WAS AROUND 220/118. THE PATIENT WAS HOSPITALIZED ABOUT 4 WEEKS POST-OP FOR STROKE LIKE SYMPTOMS (SLURRED SPEECH, CONFUSION, SEVERE HEADACHE, ETC.). THE PATIENT WAS PLACED ON BLOOD PRESSURE MEDS AND NOW AVERAGES A BLOOD PRESSURE OF 165/90. THE PATIENT STILL CONTINUES TO HAVE HEADACHES ON OCCASION AND WAS MOST RECENTLY HOSPITALIZED FOR CHEST PAIN AND SHORTNESS OF BREATH. PER THE PATIENT HEART TESTS CHECKED OUT OKAY, BUT FURTHER IMAGING HAS NOT BEEN PERFORMED TO CHECK THE PLACEMENT OF THE STENT GRAFT. THE PATIENT WAS NOW FOUND TO HAVE BLOCKED CAROTIDS BUT SURGERY HAS BEEN POSTPONED DUE TO THE ISSUES WITH BLOOD PRESSURE. THERE IS NO ADDITIONAL INFORMATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention