BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4173570 · Received October 15, 2014

    Report

    Report Number
    2953200-2014-02077
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; APPLICATION OF PROTECTIVE STENTS IN ENDOVASCULAR REPAIR OF ACUTE COMPLICATED STANFORD TYPE B AORTIC DISSECTIONS. LIU JF, JIANG WL, LU HT, LI YL, ZHANG TH, YAMAKAWA T. J ENDOVASC THER. 2013 APR;20(2):210-8. DOI: 10.1583/1545-1550-20.2.210. A VALIANT STENT GRAFT SYSTEMS WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC REPAIR. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENT WAS OBSERVED: NUMBNESS OR MYASTHENIA (ISCHEMIA), RENAL FAILURE. PURPOSE: TO DESCRIBE THE USE OF PROTECTIVE STENTS IN THE ENDOVASCULAR REPAIR OF ACUTE COMPLICATED STANFORD TYPE B AORTIC DISSECTIONS. METHODS: FROM 2009 TO 2011, 33 PATIENTS (27 MEN; MEAN AGE 47 YEARS, RANGE 31-73) WITH ACUTE COMPLICATED STANFORD TYPE B AORTIC DISSECTION UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) ASSISTED BY PROTECTIVE STENTS. IN ALL CASES, THE PROXIMAL AND DISTAL LANDING ZONES DIFFERED IN SIZE BY >5 MM, AND THE PRIMARY ENTRY TEAR WAS IN THE PROXIMAL DESCENDING AORTA. A BARE SELF-EXPANDING STENT (PROTECTIVE STENT) WAS DEPLOYED INITIALLY AT THE INTENDED DISTAL LANDING SITE OF THE PRIMARY STENT-GRAFT IN THE TRUE LUMEN. THE INTENTION WAS THAT THE BARE STENT WOULD PREVENT EXCESSIVE DILATION OF THE DISTAL END OF THE STENT-GRAFT IN THE VICINITY OF THE ENTRY TEAR, THUS AVOIDING INTIMAL RUPTURE. RESULTS: SUCCESSFUL STENT DEPLOYMENT AND SEALING OF THE ENTRY TEAR WAS ACHIEVED IN ALL PATIENTS. THE MEDIAN DIAMETER AND LENGTH OF THE PROTECTIVE BARE STENTS WAS 20.3 MM (RANGE 18-24) AND 72.7 MM (RANGE 60-80), RESPECTIVELY, WHILE THE CORRESPONDING DIMENSIONS OF THE COVERED STENT-GRAFTS WERE 32.8 MM (RANGE 26-40) AND 157.4 MM (RANGE 120-200 MM), RESPECTIVELY. THERE WAS NO STENT TWISTING, MIGRATION, OF RUPTURE OF THE FALSE OR TRUE LUMEN. COMPUTED TOMOGRAPHY 1 WEEK POSTOPERATIVELY DEMONSTRATED CLOSURE OF THE PRIMARY ENTRY TEAR WITH THROMBOSIS OF THE FALSE LUMEN IN ALL CASES. NO PATIENTS WERE LOST TO FOLLOW-UP, WHICH HAS RANGED FROM 3 MONTHS TO 3 YEARS. NO LATE ENDOLEAKS OR STENT COMPLICATIONS, SUCH AS ANGULATION, DISLODGMENT, PERSISTENT LEAKS, BRANCH OBSTRUCTION, OR STENT-GRAFT MIGRATION, HAVE BEEN OBSERVED, AND THERE HAS BEEN NO CHRONIC PROGRESSIVE TRUE OR FALSE LUMEN DILATATION, RECURRENCES, OR DEATHS. CONCLUSION: ADJUNCTIVE USE OF A PROTECTIVE STENT WHEN TREATING ACUTE STANFORD TYPE B AORTIC DISSECTIONS IN WHICH THE DIAMETERS OF THE PROXIMAL AND DISTAL LANDING ZONES DIFFER BY >5 MM IS FEASIBLE AND SAFE AND PROVIDES GOOD SHORT-TERM OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654677 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention