BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 4770043 · Received May 13, 2015

    Report

    Report Number
    9612164-2015-00684
    Event Type
    Injury
    Date Received
    May 13, 2015
    Date of Event
    July 21, 2014
    Report Date
    May 4, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; HYBRID REPAIR OF TYPE A ACUTE AORTIC DISSECTIONS WITH THE LUPIAE TECHNIQUE: TEN-YEAR RESULTS. GIAMPIERO ESPOSITO, MD, GIANGIUSEPPE CAPPABIANCA, MD, SAMUELE BICHI, MD, ANTONIO CRICCO, MD, GIOVANNI ALBANO, MD, AND ANGELO ANZUINI, MD (J THORAC CARDIOVASC SURG 2015;149:S99-104) A VALIANT STENT GRAFT SYSTEMWAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF THORACIC ANEURYSM REPAIR. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, TYPE I ENDOLEAK. OBJECTIVES: REPLACING THE ASCENDING AORTA AND THE ARCH IN PATIENTS WITH TYPE A ACUTE AORTIC DISSECTION ACHIEVES GOOD SHORT-TERM RESULTS, BUT SEVERAL PATIENTS ARE LEFT WITH DISTAL INTIMAL TEARS OR A PATENT FALSE LUMEN IN THE DESCENDING AORTA. IN THIS SERIES, WE REPORT THE 10-YEAR EXPERIENCE WITH THE LUPIAE TECHNIQUE, A HYBRID AORTIC REPAIR TECHNIQUE FOR PATIENTS WITH TYPE A ACUTE AORTIC DISSECTION. METHODS: FROM 2003 TO 2013, 89 PATIENTS WITH TYPE A ACUTE AORTIC DISSECTIONS UNDERWENT REPLACEMENT OF THE ASCENDING AORTA, THE ARCH, AND THE REROUTING OF THE NECK VESSELS ON THE ASCENDING AORTA, CREATING A PROXIMAL DACRON LANDING ZONE FOR A COMPLETION WITH THORACIC ENDOVASCULAR AORTIC REPAIR IF NECESSARY. RESULTS: IN-HOSPITAL MORTALITY WAS 8.9%. IN 16 PATIENTS, THE FALSE LUMEN HEALED SPONTANEOUSLY, WHEREAS THE REMAINING 65 PATIENTS UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR. ONE PATIENT DIED AFTER THORACIC ENDOVASCULAR AORTIC REPAIR. EIGHTY PATIENTS WERE FOLLOWED UP. COMPLETE THROMBOSIS OF THE FALSE LUMEN WAS OBTAINED IN 93.8% OF PATIENTS. THE MEDIAN FOLLOW-UP WAS 46 _ 35 MONTHS. OVERALL 8-YEAR SURVIVAL WAS 93.7% _ 5%, 100% FOR PATIENTS WITH SPONTANEOUSLY HEALED RESIDUAL FALSE LUMEN AFTER JUST TYPE A ACUTE AORTIC DISSECTION REPAIR AND 92.3%_ 7.7%FOR PATIENTS WHO UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR AFTER TYPE A ACUTE AORTIC DISSECTION REPAIR. IN 10 YEARS, 1 PATIENT UNDERWENT A REOPERATION ON THE DISTAL AORTA (1.25%). CONCLUSIONS: THE AVAILABILITY OF A DACRON LANDING ZONE ON THE DISTAL ASCENDING AORTA AFTER TYPE A ACUTE AORTIC DISSECTION REPAIR ALLOWS THE EXCLUSION, WITH A THORACIC ENDOVASCULAR AORTIC REPAIR, OF ANY RESIDUAL INTIMAL TEAR REFILLING A PATENT FALSE LUMEN. THIS APPROACH SEEMS TO BE ASSOCIATED WITH A HIGH PROBABILITY OF FALSE LUMEN THROMBOSIS AND LOW RATES OF REOPERATIONS ON THE DISTAL AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313663 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention