BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELIANT BALLOON

    MDR report key: 3623194 · Received February 11, 2014

    Report

    Report Number
    2953200-2014-00218
    Event Type
    Death
    Date Received
    February 11, 2014
    Date of Event
    October 16, 2012
    Report Date
    January 17, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS UNKNOWN. (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (DEATH, CONVERSION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; SHORT AND ANGULATED PROXIMAL AORTIC NECK). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; SHORT AND ANGULATED PROXIMAL AORTIC NECK). KNOWN INHERENT RISK OF A PROCEDURE (DEATH, CONVERSION).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. LONG-TERM EXPERIENCE WITH ENDOVASCULAR THERAPY OF THE DESCENDING THORACIC AORTA. JAN RAUPACH, JAN VOJACEK, MIROSLAV LOJIK, JAN HARRER, VENDELIN CHOVANEC, ALEXANDER FERKO, PETR HOFFMANN, PAVEL RY¿KA, ONDREJ RENC, ANTONIN KRAJINA. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, CONVERSION. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. BACKGROUND: TO REVIEW SINGLE CENTRE EXPERIENCE OF ENDOVASCULAR TREATMENT OF DESCENDING THORACIC AORTA. METHODS: BETWEEN (B)(6) 1999 AND (B)(6) 2012, 72 PATIENTS WERE TREATED OVERALL (53 MEN, 19 WOMEN, MEAN AGE 60.1 YEARS) FOR DEGENERATIVE ANEURYSMS (N = 5), RUPTURED ANEURYSMS (N = 4), AORTIC ULCERS (N = 8), INFECTED ANEURYSMS (N = 4), TYPE B AORTIC DISSECTIONS (N = 23), AND TRAUMATIC AORTIC INJURIES (N = 28). RESULTS: THE TECHNICAL SUCCESS RATE WAS 98.6%, 30-DAY MORTALITY WAS 8.3%, 1-YEAR MORTALITY WAS 13.8%, AND OVERALL MORTALITY WAS 22.2%. MORTALITY CAUSED BY THE TREATMENT OF AORTIC DISEASES WAS 6.9%. PERMANENT STROKE OCCURRED IN 1 PATIENT, AND PARAPLEGIA DEVELOPED IN 1 PATIENT. IN A GROUP OF 23 PATIENTS WHOSE LEFT SUBCLAVIAN ARTERY (LSA) WAS COVERED, CLAUDICATION OF THE LEFT UPPER EXTREMITY DEVELOPED IN 2 CASES. CONCLUSIONS: ENDOVASCULAR THERAPY OFFERS A VERY EFFECTIVE AND LESS INVASIVE ALTERNATIVE TO THE SURGICAL APPROACH FOR A WIDE RANGE OF THE THORACIC AORTIC DISEASE. THE MAIN ADVANTAGE OF USING TEVAR SEEMS TO BE IN ACUTE CONDITIONS WHEN A STENT GRAFT STABILIZES THE AORTA AND PREVENTS FURTHER BLEEDING AND ORGAN ISCHEMIA. REGULAR FOLLOW-UP IS MANDATORY FOR EARLY RECOGNITION OF SPECIFIC TEVAR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90272 RELIANT BALLOON CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Death