BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 3723031 · Received April 2, 2014

    Report

    Report Number
    2953200-2014-00619
    Event Type
    Death
    Date Received
    April 2, 2014
    Date of Event
    September 9, 2013
    Report Date
    March 7, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE (IMPLANTING THE DEVICE FOR THE TREATMENT OF BLUNT FORCE TRAUMA).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE: OUTCOMES OF ENDOVASCULAR REPAIR FOR PATIENTS WITH BLUNT TRAUMATIC AORTIC INJURY. ALI AZIZZADEH, MD, HUNTER M. RAY, BS, JOSEPH J. DUBOSE, MD, KRISTOFER M. CHARLTON-OUW, MD, CHARLES C. MILLER, PHD, SHEILA M. COOGAN, MD, HAZIM J. SAFI, MD, AND ANTHONY L. ESTRERA, MD. J TRAUMA ACUTE CARE SURG. 2014;76: 510Y516, ACCEPTED: SEPTEMBER 9, 2013. THE FOLLOWING ADVERSE EVENTS WERE REPORTED IN THE SOURCE LITERATURE. STROKE, PARAPLEGIA, RUPTURE, MIGRATION, ENDOLEAK, OPEN CONVERSION, AND ALL-CAUSE MORTALITY. THERE IS NO FURTHER INFORMATION AVAILABLE. BACKGROUND: TRAUMATIC AORTIC INJURY (TAI) REMAINS A LEADING CAUSE OF DEATH AFTER BLUNT FORCE. THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) HAS BEEN WIDELY ADOPTED AS AN ALTERNATIVE TO OPEN REPAIR FOR THE TREATMENT OF TAI. ALTHOUGH SIGNIFICANT SHORT-TERM BENEFITS HAVE BEEN DEMONSTRATED FOR PATIENTS UNDERGOING TEVAR, LONGER-TERM FOLLOW-UP DATA ARE LACKING. METHODS: TRAUMA REGISTRY DATAWERE ANALYZED. FOLLOW-UP DATAWERE GATHERED FROM A COMBINATION OF MEDICAL RECORDS, IMAGING, TELEPHONE INTERVIEWS, AND SOCIAL SECURITY DEATH INDEX. PRIMARY OUTCOMES WERE IN-HOSPITAL MORTALITY, STROKE, AND PARAPLEGIA. SECONDARY OUTCOMES INCLUDED DEVICE-RELATED ADVERSE EVENTS (RUPTURE, MIGRATION, OR ENDOLEAK), SECONDARY PROCEDURES, OPEN CONVERSION, AND ALL-CAUSE MORTALITY. RESULTS: BETWEEN SEPTEMBER 2005 AND JULY 2012, 82 CONSECUTIVE PATIENTS (57 MALES, MEAN [SD] AGE, 39.5 [20] YEARS; MEAN [SD] INJURY SEVERITY SCORE [ISS], 34 [9.5]) UNDERWENT TEVAR FOR TAI. A TOTAL OF 87 DEVICESWERE IMPLANTED: TAG (N = 36), CTAG (N = 12) (WL GORE, FLAGSTAFF, AZ); TALENT (N = 29), VALIANT (N = 5) (MEDTRONIC, SANTA ROSA, CA); TX2 (N = 2) (COOK, BLOOMINGTON, IN); AND OTHER (N = 3). LEFT SUBCLAVIAN ARTERY COVERAGE WAS REQUIRED IN 32 PATIENTS (39%). TECHNICAL SUCCESS RATE WAS 100%. RATES OF IN-HOSPITAL MORTALITY, STROKE, AND PARAPLEGIA WERE 5.0%, 2.4%, AND 0%, RESPECTIVELY. MEDIAN FOLLOW-UP TIME WAS 2.3 YEARS (RANGE, 0Y7 YEARS). THE AVAILABILITY OF FOLLOW-UP DATA WAS AS FOLLOWS: SOCIAL SECURITY DEATH INDEX (100%), TELEPHONE INTERVIEW (68%), CLINIC VISIT (61%), AND IMAGING (82%). THE INCIDENCE OF DEVICE-RELATED ADVERSE EVENTS WAS 2.4%. THERE WERE FOUR SECONDARY PROCEDURES: TWO PATIENTS UNDERWENT A CAROTID-SUBCLAVIAN BYPASS, AND TWO HAD AN OPEN CONVERSION FOR DEVICE-RELATED COMPLICATIONS. SURVIVAL WAS 95% AT 30 DAYS, 88% AT 1 YEAR, 87% AT 2 YEARS, AND 82% AT 5 YEARS. CONCLUSION: AT MIDTERM FOLLOW-UP, TEVAR IS AN EFFECTIVE AND DURABLE OPTION FOR THE TREATMENT OF TAI IN PROPERLY SELECTED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198178 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Death| R