BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 2781554 · Received October 10, 2012

    Report

    Report Number
    2953200-2012-01943
    Event Type
    Death
    Date Received
    October 10, 2012
    Report Date
    September 12, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH, ENDOLEAK, MI, RENAL FAILURE), (UNKNOWN CAUSE). CONCLUSION: (UNKNOWN CAUSE).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: EVENT RECEIVED FROM A JOURNAL ARTICLE; LONG-TERM RESULTS WITH THE TALENT THORACIC STENT GRAFT IN THE VALOR TRIAL, PAUL J FOLEY, J.JVS.2012.04.071 ON AN UNKNOWN DATE BETWEEN (B)(6) 2003 AND (B)(6) 2005, AN UNKNOWN TALENT TAA STENT GRAFT WAS IMPLANTED. DURING A RETROSPECTIVE STUDY OF 195 PATIENTS TREATED FOR TAA COMPLICATIONS, THE FOLLOWING 5-YEAR ADVERSE EVENTS WERE OBSERVED: DEATH (ANEURYSM RELATED), DEATH, DEATH (UNKNOWN), STROKE, MI, RUPTURE, DISSECTION (TYPE A), RENAL FAILURE, SEPSIS, RESPIRATORY FAILURE, CONGESTIVE HEART FAILURE, MULTI-ORGAN FAILURE, COPD, BOWEL ISCHEMIA, INFECTION, BLOOD LOSS, HEMOPTYSIS, TYPE I ENDOLEAK, TYPE III SEPARATION ENDOLEAK, TYPE II ENDOLEAK, TYPE IV ENDOLEAK, ENDOLEAK UNKNOWN, SURGICAL CONVERSION, MIGRATION, STENT GRAFT KINKING, ANEURYSM EXPANSION, PARAPLEGIA, SPINAL CORD ISCHEMIA, PARAPARESIS. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. METHODS: THE EVALUATION OF THE MEDTRONIC VASCULAR TALENT THORACIC STENT GRAFT SYSTEM FOR THE TREATMENT OF THORACIC AORTIC ANEURYSMS (VALOR) TRIAL WAS A PROSPECTIVE, NONRANDOMIZED, MULTICENTER, PIVOTAL STUDY CONDUCTED AT 38 U.S. SITES. BETWEEN (B)(6) 2003 AND (B)(6) 2005, VALOR ENROLLED 195 PATIENTS WHO WERE LOW OR MODERATE RISK (0, 1, AND 2) PER THE MODIFIED SOCIETY FOR VASCULAR SURGERY AND AMERICAN ASSOCIATION FOR VASCULAR SURGERY CRITERIA. THE PATIENTS HAD FUSIFORM THORACIC AORTIC ANEURYSMS (TAA) AND/OR FOCAL SACCULAR TAA/PENETRATING ATHEROSCLEROTIC ULCERS. STANDARD FOLLOW-UP INTERVAL EXAMINATIONS WERE CONDUCTED AT 1 MONTH, 6 MONTHS, 1 YEAR, AND ANNUALLY THEREAFTER. RESULTS: OVER THE 5-YEAR FOLLOW-UP, (B)(4) DEATHS OCCURRED ((B)(4)). FREEDOM FROM ALL-CAUSE MORTALITY WAS (B)(4) AT 1 YEAR AND 58.5% AT 5 YEARS. MOST DEATHS WERE DUE TO CARDIAC, PULMONARY OR CANCER-RELATED CAUSES. FREEDOM FROM ANEURYSM-RELATED MORTALITY (ARM) WAS (B)(4) AT 1 YEAR AND (B)(4) AT 5 YEARS. THERE WAS ONLY 1 CASE OF ARM AFTER THE FIRST YEAR OF FOLLOW-UP. OVER THE 5-YEAR FOLLOW-UP PERIOD, FOUR PATIENTS WERE CONVERTED TO OPEN SURGERY AND FOUR PATIENTS EXPERIENCED ANEURYSM RUPTURE. THE 5-YEAR FREEDOM FROM ANEURYSM RUPTURE WAS (B)(4) AND THE 5-YEAR FREEDOM FROM CONVERSION TO SURGERY WAS (B)(4). THE INCIDENCE OF STENT GRAFT MIGRATION (>10 MM) WAS <(><<)>(B)(4) IN EACH YEAR OF FOLLOW-UP. THE RATE OF TYPE I ENDOLEAK WAS (B)(4) AT 1 MONTH, (B)(4) FROM 1 MONTH TO 1 YEAR, AND (B)(4) DURING YEAR 5. THE RATE OF TYPE III ENDOLEAK WAS 1.3% AT 1 MONTH, (B)(4) FROM 1 MONTH TO 1 YEAR, AND (B)(4) DURING YEAR 5. THROUGH 5 YEARS, (B)(4) PATIENTS ((B)(4)) UNDERWENT 31 ADDITIONAL ENDOVASCULAR PROCEDURES ON THE ORIGINAL TARGET LESION. THE 5-YEAR FREEDOM FROM SECONDARY ENDOVASCULAR PROCEDURES WAS (B)(4). CONCLUSIONS: THROUGH 5-YEAR FOLLOW-UP IN PATIENTS WHO WERE CANDIDATES FOR OPEN SURGICAL REPAIR, TEVAR USING THE TALENT THORACIC STENT GRAFT SYSTEM HAS DEMONSTRATED SUSTAINED PROTECTION FROM ARM, ANEURYSM RUPTURE, AND CONVERSION TO SURGERY, AND DURABLE STENT GRAFT PERFORMANCE. CLOSE PATIENT FOLLOW-UP REMAINS ESSENTIAL AFTER TEVAR. EXACT DATE OF DEATH AND OR EVENTS UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R