BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4221041 · Received November 3, 2014

    Report

    Report Number
    2953200-2014-02270
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. IMPACT ON OUTCOMES BY MEASURING TORTUOSITY WITH REPORTING STANDARDS FOR THORACIC ENDOVASCULAR AORTIC REPAIR. CHUN-KU CHEN, I-PING LIANG, HSIAO-TING CHANG, WEI-YUAN CHEN, I-MING CHEN, MEI-HAN WU, MING-HUEI SHEU, AND CHUN-CHE SHIH. SOCIETY FOR VASCULAR SURGERY. 2014, 60:937-44. ON UNKNOWN DATES BETWEEN NOVEMBER 2006 TO MAY 2013, VALIANT AND TALENT STENT GRAFTS WERE IMPLANTED IN ZONE ZERO, ONE TWO, THREE AND FOUR FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: STROKE, ENDOLEAKS (I,III (UNKNOWN), SPINAL CORD INJURY, LIMB ISCHEMIA, RENAL FAILURE, SEPSIS, INFECTION, HEMATEMESIS, SUBARACHNOID HEMORRHAGE, CEREBELLAR INFARCTION, SEPSIS, MASSIVE INTRAMUSCULAR HEMORRHAGE, DEATH, RUPTURE. OBJECTIVE: IN THIS STUDY, WE ASSESSED THE ASSOCIATION BETWEEN THE TORTUOSITY OF THE THORACIC AORTA AS MEASURED BY THE REPORTING STANDARDS FOR THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR), DESCRIBED BY THE SOCIETY FOR VASCULAR SURGERY, AND MIDTERM OUTCOMES AFTER TEVAR FOR ATHEROSCLEROTIC ANEURYSMS. METHODS: WE ANALYZED 77 CONSECUTIVE PATIENTS WHO UNDERWENT TEVAR FOR ATHEROSCLEROTIC ANEURYSMS FROM NOVEMBER 2006 THROUGH MAY 2013 IN A SINGLE INSTITUTION. THE PREOPERATIVE AORTIC TORTUOSITY INDEX (TI) WAS CALCULATED BY COMPUTED TOMOGRAPHY AORTOGRAPHY, AND PATIENTS WERE DIVIDED INTO LOW-TORTUOSITY (TI # 1.29) AND HIGH-TORTUOSITY (TI > 1.29) GROUPS. THE RELATIONSHIPS BETWEEN TI AND THE OCCURRENCE OF ENDOLEAKS, COMPLICATIONS, AND SURVIVAL WERE ANALYZED. RESULTS: THE MEAN FOLLOW-UP PERIOD WAS 29 6 26 MONTHS. DURING THIS PERIOD, ENDOLEAKS OCCURRED IN 19 PATIENTS. PATIENTS IN THE HIGH-TORTUOSITY GROUP WERE AT GREATER RISK FOR ENDOLEAKS (ODDS RATIO, 9.95; 95% CONFIDENCE INTERVAL, 2.06-48.1; P [.004) AND STROKE (ODDS RATIO, 13.2; 95% CONFIDENCE INTERVAL, 1.03-169; P [ .047) THAN THOSE IN THE LOW-TORTUOSITY GROUP. THE OVERALL SURVIVAL AT 1, 3, AND 5 YEARS WAS 73%, 69%, AND 63%, RESPECTIVELY, FOR THE HIGH-TORTUOSITY GROUP AND 92%, 92%, AND 86%, RESPECTIVELY, FOR THE LOW TORTUOSITY GROUP. CONCLUSIONS: OUR FINDINGS DEMONSTRATED THAT HIGH TORTUOSITY OF THE THORACIC AORTA IS ASSOCIATED WITH HIGHER RATES OF ENDOLEAKS AND LOWER SURVIVAL IN PATIENTS UNDERGOING TEVAR FOR ATHEROSCLEROTIC ANEURYSMS. PATIENTS WITH ANEURYSMS IN A HIGHLY TORTUOUS AORTA MAY THEREFORE NEED GREATER ATTENTION IN PREOPERATIVE PLANNING, PERIOPERATIVE PROCEDURES, AND FOLLOW-UP EXAMINATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702829 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR