BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA UNK

    MDR report key: 9489568 · Received December 18, 2019

    Report

    Report Number
    9612164-2019-05227
    Event Type
    Death
    Date Received
    December 18, 2019
    Date of Event
    June 26, 2019
    Report Date
    December 18, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; HOMEMADE FENESTRATED STENT-GRAFTS FOR COMPLETE ENDOVASCULAR REPAIR OF AORTIC ARCH DISSECTIONS LUDOVIC CANAUD, BARIS ATA OZDEMIR, CHASSIN-TRUBERT, JULIEN SFEIR, PIERRE ALRIC AND THOMAS GANDET JOURNAL OF ENDOVASCULAR THERAPY 2019 26(5) HTTPS://DOI.ORG/10.1177/1526602819858578. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE THORACIC ENDOVASCULAR ANEURYSM REPAIR OF AORTIC ARCH DISSECTIONS. THE FOLLOWING EVENTS WERE REPORTED- DEATH: WITHIN 30 DAYS OF INDEX PROCEDURE IN TWO PATIENTS WITH RUPTURED DISSECTED AORTIC ARCH ANEURYSMS AND THREE LATE DEATHS (ONE OF NON-AORTIC CAUSE) MEDICAL HISTORY: HYPERTENSION, DYSLIPIDEMIA, DIABETES MELLITUS, COPD 6, CORONARY ARTERY DISEASES AND LVEF 40% ABSTRACT PURPOSE: TO EVALUATE OUTCOMES OF HOMEMADE FENESTRATED STENT-GRAFTS FOR COMPLETE ENDOVASCULAR AORTIC REPAIR OF AORTIC ARCH DISSECTIONS. MATERIALS AND METHODS: FROM JULY 2014 THROUGH SEPTEMBER 2018, 35 PATIENTS (MEAN AGE 66±11 YEARS; 25 MEN) UNDERWENT HOMEMADE FENESTRATED STENT-GRAFT REPAIR OF ACUTE (N=16) OR CHRONIC (N=10) COMPLICATED TYPE B AORTIC DISSECTIONS (N=16) AND DISSECTING AORTIC ARCH ANEURYSMS SUBSEQUENT TO SURGICAL TREATMENT OF ACUTE TYPE A DISSECTIONS (N=9). NINETEEN (54%) PROCEDURES WERE EMERGENT. RESULTS: ZONE 2 SINGLE-FENESTRATED STENT-GRAFTS WERE USED IN 25 CASES; THE REMAINING 10 WERE DOUBLE-FENESTRATED STENT-GRAFTS DEPLOYED IN ZONE 0. MEDIAN TIME FOR STENT-GRAFT MODIFICATION WAS 18 MINUTES (RANGE 16¿20). TECHNICAL SUCCESS WAS ACHIEVED IN ALL CASES. AN IMMEDIATE DISTAL TYPE I ENDOLEAK WAS TREATED INTRAOPERATIVELY. AMONG THE DOUBLE-FENESTRATED STENT-GRAFT CASES, THE LEFT SUBCLAVIAN ARTERY FENESTRATION COULD NOT BE CANNULATED IN 2 PATIENTS AND REVASCULARIZATION WAS REQUIRED. PARTIAL COVERAGE OF THE LEFT COMMON CAROTID ARTERY NECESSITATED PLACEMENT OF A COVERED STENT IN 3 CASES. ONE (3%) PATIENT HAD A STROKE WITHOUT PERMANENT SEQUELAE. TWO TYPE II ENDOLEAKS REQUIRED ADDITIONAL COVERED STENT PLACEMENT AT 5 AND 7 DAYS POSTOPERATIVELY, RESPECTIVELY. THE 30-DAY MORTALITY WAS 6% (2 PATIENTS WITH RUPTURED AORTIC ARCH ANEURYSM). DURING A MEAN FOLLOW-UP OF 17.6±13 MONTHS, THERE WAS NO AORTIC RUPTURE OR RETROGRADE DISSECTION. ONE LATE TYPE I ENDOLEAK WAS TREATED WITH ADDITIONAL PROXIMAL FENESTRATED STENT-GRAFT PLACEMENT. ONE TYPE II ENDOLEAK IS CURRENTLY UNDER OBSERVATION. ONE ADDITIONAL PATIENT DIED (UNRELATED TO THE AORTA); OVERALL MORTALITY WAS 9%. ALL SUPRA-AORTIC TRUNKS WERE PATENT. CONCLUSION: THE USE OF HOMEMADE FENESTRATED STENT-GRAFTS FOR ENDOVASCULAR REPAIR OF AORTIC ARCH DISSECTIONS IS FEASIBLE AND EFFECTIVE FOR TOTAL ENDOVASCULAR AORTIC ARCH REPAIR. DURABILITY CONCERNS WILL NEED TO BE ASSESSED IN ADDITIONAL STUDIES WITH LONG-TERM FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285581 VALIANT CAPTIVIA UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death