BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 4770041 · Received May 13, 2015

    Report

    Report Number
    9612164-2015-00682
    Event Type
    Injury
    Date Received
    May 13, 2015
    Date of Event
    May 26, 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
    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; THE CHIMNEY TECHNIQUE FOR PRESERVING THE LEFT SUBCLAVIAN ARTERY IN THORACIC ENDOVASCULAR AORTIC REPAIR. YUGUO XUE, LIZHONG SUN, JUN ZHENG, XIAOYONG HUANG, XI GUO, TIEZHENG LIA AND LIANJUN HUANG. (EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 47 (2015) 623¿629. ADVANCE ACCESS PUBLICATION 9 JULY 2014) A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF THORACIC TYPE B AORTIC DISSECTION, PENETRATING AORTIC ULCER, AORTIC ARCH ANEURYSM, AORTIC ARCH PSEUDOANEURYSM, AND A PROXIMAL TYPE I ENDOLEAK AFTER A PREVIOUS ENDO VASCULAR REPAIR FOR AORTIC DISSECTION. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, TYPE IA ENDOLEAK, TYPE I ENDOLEAK, STROKE, RADIAL ARTERIAL OCCLUSION, CHEST AND BACK PAIN POSSIBLY ARISING FROM ACUTE SPINAL CORD ISCHEMIA, ABRUPT HAEMOPTYSIS, RUPTURE PSEUDOANEURYSM. CEREBRAL INFARCTION, DIZZINESS, NAUSEA, BLOOD PRESSURE ELEVATION, UNCONSCIOUSNESS, PULSE DIMINUTION, STENOSIS. OBJECTIVES: THE OBJECTIVE OF THE PRESENT STUDY WAS TO EVALUATE SHORT- AND MID-TERM OUTCOMES OF THE LEFT SUBCLAVIAN ARTERY (LSA) CHIMNEY STENT IMPLANTATION (LSACSI) DURING THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR), AND TO SUMMARIZE OUR EXPERIENCE WITH THIS TECHNIQUE. METHODS: FROM (B)(6) 2010 TO (B)(6) 2012, 59 PATIENTS (49 MEN; MEAN AGE OF 57.4 ± 13.3 YEARS, RANGE FROM 26 TO 83 YEARS) WHO UNDERWENT TEVAR AND LSACSI WERE ENROLLED. PATIENTS SUFFERED FROM STANFORD TYPE B AORTIC DISSECTION (N = 27), PENETRATING AORTIC ULCER (N = 18), AORTIC ARCH ANEURYSM (N = 9), PSEUDOANEURYSM OF THE AORTIC ARCH (N = 4) AND PROXIMAL TYPE I ENDOLEAK AFTER TEVAR OF AORTIC DISSECTION (N = 1). ELECTIVE SETTINGS WERE PERFORMED IN 72% AND EMERGENT IN 38% OF ALL PATIENTS. FOLLOW-UP WAS PERFORMED AT POSTOPERATIVE 3 MONTHS, 6 MONTHS AND YEARLY THEREAFTER. RESULTS: THE TECHNICAL SUCCESS RATE WAS 98.3% (58/59), AND 69 THORACIC STENT GRAFTS WERE USED. SIXTY-TWO CHIMNEY STENTS, INCLUDING 55 UNCOVERED AND 7 COVERED STENTS, WERE IMPLANTED IN 59 LSAS. THE OVERALL IMMEDIATE ENDOLEAK RATE WAS 15.3% (9/59); TYPE I ENDOLEAK WAS OBSERVED IN 5 PATIENTS AND TYPE II IN 4 PATIENTS. THE DIFFERENCE IN THE IMMEDIATE ENDOLEAK RATE RELATED TO THE ANATOMY BETWEEN THE OUTER AND THE INNER CURVATURE WAS STATISTICALLY SIGNIFICANT (35 VS 4%, P = 0.018). CHIMNEY STENT COMPRESSION WAS OBSERVED IN 3 PATIENTS AND ANOTHER STENT WAS DEPLOYED INSIDE THE FIRST ONE. PERIOPERATIVE COMPLICATIONS INCLUDED STROKE (3.4%, 2/59) AND LEFT UPPER LIMB ISCHAEMIA (1.7%, 1/59). THE MEDIAN FOLLOW-UP PERIOD WAS 16.5 (RANGE 1¿39 MONTHS). THE MORTALITY RATE DURING FOLLOW-UP WAS 5.4% (3/56). COMPLICATIONS DURING FOLLOW-UP INCLUDED ENDOLEAK [OVERALL, N = 8 (14.3%, 8/56); TYPE I, N = 5; TYPE II, N = 3], RETROGRADE TYPE A AORTIC DISSECTION (N = 1), COLLAPSE (N = 3, 5.4%) OR OCCLUSION (N = 2, 3.6%) OF THE CHIMNEY STENT. CONCLUSIONS: SHORT- AND MID-TERM RESULTS SHOWED THAT IT IS FEASIBLE TO PRESERVE THE PATENCY OF THE LSA IN TEVAR WITH THE CHIMNEY TECHNIQUE FOR THORACIC AORTIC PATHOLOGIES CLOSE TO THE LSA. HOWEVER, TEVAR COMBINED WITH LSACSI WAS NOT ADVOCATED FOR LESIONS LOCATED AT THE OUTER CURVE OF THE AORTIC ARCH DUE TO A HIGH POSSIBILITY OF ENDOLEAK. RELEVANT MEDICAL HISTORY: HYPERTENSION, CORONARY HEART DISEASE, DIABETES, CEREBROVASCULAR DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311958 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention