BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 7281608 · Received February 20, 2018

    Report

    Report Number
    2953200-2018-00245
    Event Type
    Malfunction
    Date Received
    February 20, 2018
    Date of Event
    April 30, 2017
    Report Date
    February 20, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; RESTRICTIVE BARE STENT PREVENTS DISTAL STENT GRAFT-INDUCED NEW ENTRY IN ENDOVASCULAR REPAIR OF TYPE B AORTIC DISSECTION YANG ZHAO, MD, PHD, HENGHUI YIN, MD, PHD, YITIAN CHEN, MD, MIAN WANG, MD, PHD, LIANG ZHENG, MD, ZILUN LI, MD, PHD, AND GUANGQI CHANG, MD, GUANGDONG, CHINA COPYRIGHT 2017 BY THE SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC. HTTP://DX.DOI.ORG/10.1016/J.JVS.2017.04.066. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF THORACIC TYPE B AORTIC DISSECTION. THE FOLL OWING ADVERSE EVENTS WERE OBSERVED: DEATH, TYPE I ENDOLEAK, PROXIMAL <(>&<)> DISTAL STENT GRAFT-INDUCED NEW ENTRY (SINE), FALSE LUMEN THROMBOSIS OBJECTIVE: DISTAL STENT GRAFT-INDUCED NEW ENTRY (SINE) CAN OCCUR AFTER THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) OF TYPE B AORTIC DISSECTION. THIS STUDY INVESTIGATED THE MECHANISM OF DISTAL SINE AND ITS PREVENTION USING A RESTRICTIVE BARE STENT (RBS) TECHNIQUE. METHODS: FROM JANUARY 2013 TO DECEMBER 2014, 68 CONSECUTIVE TYPE B AORTIC DISSECTION PATIENTS RECEIVED ENDOVASCULAR REPAIR AT OUR CENTER. THE RBS TECHNIQUE WAS USED WITH DISTAL OVERSIZING (BETWEEN THE DIAMETER OF THE THORACIC STENT GRAFT AND THE DESCENDING AORTA TRUE LUMEN DIAMETER AT THE LEVEL OF THE INTENDED DISTAL EDGE OF THE THORACIC STENT GRAFT) >20%. RESULTS: TWENTY-THREE PATIENTS RECEIVED TEVAR WITH A SINGLE THORACIC STENT GRAFT (TEVAR GROUP, N ¼ 23); THE REST RECEIVED TEVAR COMBINED WITH THE RBS TECHNIQUE (TEVAR Þ RBS GROUP, N ¼ 45). FOUR DISTAL SINES OCCURRED IN THE TEVAR GROUP. DISTAL OVERSIZING (69.7% 6 35.5% VS 31.2% 6 24.5%; P ¼ .005) AND EXPANSION MISMATCH RATIO (132.2% 6 16.9% VS 106.5% 6 11.6%; P <(><<)> .05) WERE SIGNIFICANTLY HIGHER IN THE SINE PATIENTS. COMPARED WITH STANDARD TEVAR, TEVAR Þ RBS WAS ASSOCIATED WITH SIGNIFICANTLY LOWER DISTAL OVERSIZING (TEVAR VS TEVAR Þ RBS GROUP, 59.8% 6 24.7% VS 16.7% 6 7.6%; P <(><<)> .05), LOWER EXPANSION MISMATCH RATIO (113.8% 6 14.6% VS 103.8% 6 11.7%; P ¼ .012), AND LOWER DISTAL SINE RATE (4/23 [17.4%] VS 0/45 [0%]; P ¼ .011). COMPARED WITH THE TEVAR GROUP, THE FALSE LUMEN WAS REDUCED SIGNIFICANTLY AT THE LEVEL OF THE RBS DISTAL EDGE (P ¼ .029). CONCLUSIONS: EXCESSIVE DISTAL OVERSIZING AND DISTAL EXPANSION MISMATCH RATIO MAY CONTRIBUTE TO THE OCCURRENCE OF DISTAL SINE. THE RBS TECHNIQUE REDUCED THE INCIDENCE OF DISTAL SINE. BASED ON OUR MIDTERM AND LONG-TERM OBSERVATIONS, IMPLANTATION OF AN RBS MAY IMPROVE AORTIC REMODELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125281 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR