BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 5079653 · Received September 15, 2015

    Report

    Report Number
    2953200-2015-01566
    Event Type
    Injury
    Date Received
    September 15, 2015
    Date of Event
    April 22, 2014
    Report Date
    August 24, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT DATES OF THE EVENTS ARE UNKNOWN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; DEBRANCHING SOLUTIONS IN ENDOGRAFTING FOR COMPLEX THORACIC AORTIC DISSECTIONS ONUR SELCUK GOKSEL, KORAY GUVEN, CELALETTIN KARATEPE, EMRE GOK, BULENT ACUNAS, BAYER CINAR, UFUK ALPAGUT (ARQ BRAS CARDIOL. 2014; 1 03(2):154-160) A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF THORACIC ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED:DISSECTION BACKGROUND: CONVENTIONAL SURGICAL REPAIR OF THORACIC AORTIC DISSECTIONS IS A CHALLENGE DUE TO MORTALITY AND MORBIDITY RISKS. OBJECTIVES: WE ANALYZED OUR EXPERIENCE IN HYBRID AORTIC ARCH REPAIR FOR COMPLEX DISSECTIONS OF THE AORTIC ARCH. METHODS: BETWEEN 2009 AND 2013, 18 PATIENTS (THE MEAN AGE OF 67 +/- 8 YEARS-OLD) UNDERWENT HYBRID AORTIC ARCH REPAIR. THE PROCEDURAL STRATEGY WAS DETERMINED ON THE INDIVIDUAL PATIENT. RESULTS: THIRTEEN PATIENTS HAD TYPE I REPAIR USING TRIFURCATION AND ANOTHER PATIENT WITH BIFURCATION GRAFT. TWO PATIENTS HAD TYPE II REPAIR WITH REPLACEMENT OF THE ASCENDING AORTA. TWO PATIENTS RECEIVED EXTRA-ANATOMIC BYPASS GRAFTING TO LEFT CAROTID ARTERY ALLOWING COVERING OF ZONE 1. STENT GRAFT DEPLOYMENT RATE WAS 100%. NO PATIENTS EXPERIENCED STROKE. ONE PATIENT WITH TOTAL DEBRANCHING OF THE AORTIC ARCH FOLLOWING AN ACUTE DISSECTION OF THE PROXIMAL ARCH EXPIRED 3 MONTHS AFTER TEVAR DUE TO HEART FAILURE. THERE WERE NO EARLY TO MIDTERM ENDOLEAKS. THE MEDIAN FOLLOW-UP WAS 20 ᠸ MONTHS WITH PATENCY RATE OF 100%. CONCLUSION: VARIOUS DEBRANCHING SOLUTIONS FOR DIFFERENT COMPLEX SCENARIOS OF THE AORTIC ARCH SERVE AS LESS INVASIVE PROCEDURES THAN CONVENTIONAL OPEN SURGERY ENABLING SAFE AND EFFECTIVE TREATMENT OF THIS HIGHLY SELECTED SUBGROUP OF PATIENTS WITH COMPLEX AORTIC PATHOLOGIES. (ARQ BRAS CARDIOL. 2014; 103(2):154-160)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610603 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention