BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 6766336 · Received August 4, 2017

    Report

    Report Number
    2953200-2017-01234
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    July 9, 2016
    Report Date
    July 12, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE TITLE; POSTOPERATIVE STROKE AFTER DEBRANCHING WITH THORACIC ENDOVASCULAR AORTIC REPAIR AKIHIRO YOSHITAKE, TAKASHI HACHIYA, KAZUMA OKAMOTO, HIROTO KITAHARA, SHINJI KAWAGUCHI, SEISHI NAKATSUKA, MASANORI INOUE, MASAHIRO JINZAKI, AND HIDEYUKI SHIMIZU, TOKYO, JAPAN ANN VASC SURG 2016; 36: 132¿138 HTTP://DX.DOI.ORG/10.1016/J.AVSG.2016.02.039 .

    Description of Event or Problem · 1

    THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: OPEN CONVERSION, DEATH, STROKE, RENAL FAILURE, SPINAL CORD ISCHEMIA, TYPE I ENDOLEAK, TYPE III ENDOLEAK. OBJECTIVES: THIS STUDY AIMED TO ANALYZE THE PERIOPERATIVE STROKE RATE, STROKE LESIONS, OUTCOME, RISK FACTORS,AND STROKE PREVENTION FOLLOWING DEBRANCHING WITH THORACIC ENDOVASCULAR AORTIC REPAIR(TEVAR). DESIGN: RETROSPECTIVE STUDY. METHODS: BETWEEN FEBRUARY 2011 AND FEBRUARY 2015, 74 CONSECUTIVE PATIENTS UNDERWENT DEBRANCHING WITH TEVAR AT OUR INSTITUTION. OF THESE, THE TEVAR PROXIMAL LANDING ZONE WAS ¿¿ZONE 0¿¿ IN 23 PATIENTS, ¿¿ZONE 1¿¿ IN 28, AND ¿¿ZONE 2¿¿ IN 23. LEFT SUBCLAVIAN ARTERY (LSA) OCCLUSION WITH COIL EMBOLIZATION, BALLOON OCCLUSION, OR VASCULAR PLUGGING WAS PERFORMED IN 27 PATIENTS. MEAN FOLLOW-UP TIME WAS 19.2 MONTHS (RANGE 2E52 MONTHS). RESULTS: THE IN-HOSPITAL MORTALITY RATE WAS 4.1%. STROKE DEVELOPED IN 7 PATIENTS (9.5%), ZONE 0 IN 4 PATIENTS, ZONE 1 IN 2, AND ZONE 2 IN 1. SIX OF THESE PATIENTS HAD STROKE LESIONS ARISING FROM THE VERTEBRAL/BASILAR ARTERY. UNIVARIATE ANALYSIS REVEALED A SIGNIFICANT INCREASE IN THE RISK OF POSTOPERATIVE STROKE IN PATIENTS WITH INTRALUMINAL ATHEROMA (P ¼ 0.001), THOSE WHO UNDERWENT PRIOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY OR CORONARY ARTERY BYPASS GRAFT (P = 0.002), AND THOSE WITH A LONG OPERATIVE DURATION (P = 0.001). ADDITIONALLY, LSA OCCLUSION SIGNIFICANTLY DECREASED THE INCIDENCE OF STROKE (P = 0.041). THE POSTSURGICAL 1- AND 2-YEAR CUMULATIVE SURVIVAL RATES WERE 87.3% AND 77.0%, RESPECTIVELY, IN THOSE WITHOUT STROKE, AND 68.6% AND 22.9%, RESPECTIVELY, IN THOSE WITH STROKE (P = 0.012). CONCLUSIONS: STROKE AFTER DEBRANCHING WITH TEVAR WAS ASSOCIATED WITH A HIGH MORTALITY. TO PREVENT STROKE, CAREFUL PATIENT SELECTION AND PROTECTION OF THE VERTEBRAL ARTERY ARE IMPORTANT. PROPHYLACTIC LSA OCCLUSION AT THE TIME OF STENT-GRAFT DEPLOYMENT MIGHT REDUCE THE RISK OF PERIOPERATIVE STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547630 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention