BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 4930259 · Received July 21, 2015

    Report

    Report Number
    2953200-2015-01085
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    February 9, 2015
    Report Date
    June 30, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    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; ENDOVASCULAR REPAIR OF STANFORD B AORTIC DISSECTION USING TWO STENT GRAFTS WITH DIFFERENT SIZES. XIAOYONG HUANG, MD, LIANJUN HUANG, MD, LIZHONG SUN, MD, SHANGDONG XU, MD, YUGUO XUE, MD, QINGLONG ZENG, MD, XI GUO, MD, AND MINGLIANG PENG, MD, BEIJING, CHINA VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENTS FOR THE ENDOVASCULAR TREATMENT OF STANFORD B AORTIC DISSECTION. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: ENDOLEAKS, STENT GRAFT MIGRATION, PARAPLEGIA, MAL-PERFUSION, ACUTE SPINAL CORD ISCHEMIA, MAL-POSITION OF THE STENT GRAFT. OBJECTIVE: THE OBJECTIVE OF THIS STUDY WAS TO INTRODUCE A NOVEL STRATEGY FOR THORACIC ENDOVASCULAR AORTIC REPAIR OF STANFORD B AORTIC DISSECTION USING TWO-STENT GRAFT IMPLANTATION (TSI), IN WHICH THE PROXIMAL STENT AND DISTAL STENT WITH DIFFERENT SIZES ARE SEQUENTIALLY DEPLOYED, AND TO SUMMARIZE OUR EXPERIENCE WITH THIS TECHNIQUE. METHODS: A RETROSPECTIVE STUDY WAS CONDUCTED OF 72 CONSECUTIVE PATIENTS (61 MEN; MEAN AGE, 55 6 7 YEARS; RANGE, 41-67 YEARS) WITH STANFORD TYPE B AORTIC DISSECTION WHO UNDERWENT TSI TREATMENT BETWEEN JANUARY 2012 AND MAY 2013. AMONG ALL PATIENTS, 43 (59.7%) INVOLVED THE INFRARENAL AORTA AND 29 (40.3%) INVOLVED THE WHOLE THORACIC AND ABDOMINAL AORTA; MEAN AORTIC INVOLVEMENT LENGTH WAS 226 6 13 MM (RANGE, 182-312 MM). EIGHT CASES WERE FOR ACUTE DISSECTION (WITHIN 2 WEEKS FROM ONSET OF SYMPTOMS), 11 CASES WERE FOR CHRONIC DISSECTION (>3 MONTHS AFTER INITIAL DISSECTION), AND 53 CASES WERE FOR SUBACUTE DISSECTION (BETWEEN 2 WEEKS AND 3 MONTHS). TWENTY-TWO CASES (30.6%) WERE UNCOMPLICATED TYPE AND 50 CASES (69.4%) WERE COMPLICATED TYPE. FOLLOW-UP WAS PERFORMED POSTOPERATIVELY AT 1 MONTH, 6 MONTHS, AND YEARLY THEREAFTER. TECHNIQUE SUCCESS, AORTA MORPHOLOGY, AND PROCEDURE-RELATED COMPLICATIONS WERE EVALUATED. RESULTS: TECHNICAL SUCCESS WAS ACHIEVED IN 100%; 72 PAIRS OF STENT GRAFTS (144 THORACIC STENT GRAFTS) AND 10 LEFT SUBCLAVIAN ARTERY CHIMNEY STENTS WERE USED. THE MEAN AORTIC LENGTH COVERAGE BY THE STENT GRAFTS WAS 197.6 6 20.3 MM, AND MEAN TAPER DIAMETER SPAN WAS 7.5 6 1.8 MM. ALL PATIENTS WERE FOLLOWED UP FROM 6 TO 16 MONTHS (MEAN, 10 6 4 MONTHS); 95.8% (69 OF 72) HAD A THROMBOSED FALSE LUMEN IN THE AORTIC COVERAGE, AND THE TRUE LUMEN EXPANDED ON AVERAGE 57% 6 11% (23%-100%). NO SIGNIFICANT CHANGES WERE FOUND IN AORTIC DIAMETERS OF THE PROXIMAL AND DISTAL ENDS OF THE TWO STENT GRAFTS AND THE ANGLES BETWEEN CENTERLINES OF THE DISTAL END OF THE STENT AND THE AORTA DURING FOLLOW-UP. PROCEDURE-RELATED COMPLICATIONS INCLUDED TRANSIENT PARAPLEGIA (COVERAGE OF THE LEFT SUBCLAVIAN ARTERY WITHOUT REVASCULARIZATION AND EXTENSIVE COVERAGE OF AORTA >220 MM) DUE TO ACUTE SPINAL CORD ISCHEMIA (N [ 1) AND MALAPPOSITION OF THE DISTAL STENT (PRIMARY TEAR CLOSED, TRUE LUMEN EXPANSION LED TO OVERSIZE RATE INSUFFICIENT IN DISTAL STENT DIAMETER; N [ 1). NO DEATH OR MALPERFUSION COMPLICATIONS WERE OBSERVED DURING THE PERIOPERATIVE PERIOD AND FOLLOW-UP. CONCLUSIONS: SHORT-TERM OUTCOMES SHOWED TSI TO BE A FLEXIBLE AND EFFECTIVE APPROACH TO ACCURATELY REPAIR STANFORD B AORTIC DISSECTION THAT COULD POTENTIALLY ADDRESS THE LIMITATIONS OF CURRENTLY AVAILABLE STENT GRAFTS. FURTHER PROSPECTIVE CLINICAL STUDIES ARE WARRANTED TO EVALUATE ITS LONG-TERM EFFICACY. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471646 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention