BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH

    MDR report key: 2071846 · Received April 21, 2011

    Report

    Report Number
    MW5020382
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    September 1, 2010
    Report Date
    April 21, 2011
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HI! FOLKS, RE: LIFE-THREATENING HYPERTENSION RESPONSE TO AAA-STENT GRAFT. I WAS FORTUNATELY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM BY THE INSERTION OF A COOK ZENITH STENT GRAFT, WHICH WAS VERY EFFECTIVE AND REALLY EXTENDED MY LIFE. FOLLOWING THIS GREAT TREATMENT I DEVELOPED A SEVERE HYPERTENSION, 220/115, WHICH WAS CORRECTED EVENTUALLY BY THE USE OF AN ACE INHIBITOR AND EXERCISE. I HAVE FOUND ANOTHER PERSON WITH AN IDENTICAL BLOOD PRESSURE RESPONSE, BUT IN THIS CASE, IT WAS TO A MEDTRONIC STENT. RISK OF HYPERTENSION IS LISTED IN THE MEDTRONIC FINE PRINT FOR THE DEVICE, BUT IT IS HIDDEN IN A LIST OF ABOUT ANYTHING THAT MIGHT GO WRONG. CAN YOU HELP ME TO ENCOURAGE PEOPLE DELIVERING THESE DEVICES TO ROUTINELY CHECK FOR THIS RISK, WHICH IN SOME PATIENTS COULD BE A VERY DANGEROUS SEQUEL TO TREATMENT? MY STORY IS DETAILED IN MY BLOG AT (B)(6) UNDER THE SUBJECT OF HYPERTENSION. THE DEVICE IS GREAT, BUT THE HYPERTENSION IS 'FRIGHTENING' AND MEDICAL PERSONNEL REFUSED TO ACCEPT A LINK WITH THE STENT, WHICH I THINK IS VERY CLEAR NOW - SEE DATA IN MY BLOG. I DON'T WANT TO CAUSE TROUBLE FOR THE MANUFACTURERS OF THESE GREAT PRODUCTS, I JUST WANT APPROPRIATE FOLLOW-UP MEASURES TAKEN FOR THIS RISK FOR FUTURE PATIENTS. ALL HELP OR ADVICE WOULD BE MUCH APPRECIATED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA-STENT GRAFT MIH

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| S