BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4085107 · Received September 12, 2014

    Report

    Report Number
    2953200-2014-01810
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    April 1, 2011
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: AORTIC ARCH REDO SURGERY FOR ENDOGRAFT MIGRATION AND PREMATURE THROMBOSIS OF DEBRANCHING GRAFT. YIHUA LIU, PABLO MAUREIRA, THIERY FOLLIGUET, JEAN-PIERRE VILLEMOT. THORAC CARDIOVASC SURG REP 2013;2:53¿56. IN (B)(6) 2011, A (B)(6) MAN MET WITH A TRAFFIC ACCIDENT THAT RESULTED IN A POLYTRAUMA, SPECIFICALLY LEFT DIAPHRAGMATIC RUPTURE WITH INTESTINAL HERNIA, INTRATHORACIC SPLEEN RUPTURE, HEPATIC AND PANCREATIC CONTUSION, MULTIPLE FRACTURE, AND AORTIC ISTHMUS RUPTURE. AFTER GENERAL AND ORTHOPEDIC EMERGENCY OPERATION IN A LOCAL HOSPITAL, THE PATIENT WAS TRANSFERRED TO OUR CENTER FOR THE MANAGEMENT OF TRAUMATIC RUPTURE OF THE AORTIC ISTHMUS. AFTER PRECISE SIZING, WE DECIDED TO IMPLANT AN ENDOVASCULAR STENT GRAFT (MEDTRONIC VALIANT, MEDTRONIC INC., MINNEAPOLIS, UNITED STATES, 24 MM _ 10 CM) THROUGH FEMORAL ARTERY IN HYBRID OPERATING ROOM. TO ACHIEVE A SAFE LANDING ZONE (> 20 MM), WE HAVE PLANNED TO OCCLUDE THE LEFT SUBCLAVIAN ARTERY. HOWEVER, DURING DEPLOYMENT OF THE ENDOVASCULAR GRAFT, THE STENT GRAFT MIGRATED CRANIALLY INTO THE ZONE ¿0,¿ WHICH WAS CONFIRMED BY PERIOPERATIVE ANGIOGRAPHY; FORTUNATELY, THE SUPRA-AORTIC VESSELS WERE PERMEABLE BECAUSE OF A TYPE I ENDOLEAK. WE IMMEDIATELY CONVERTED TO OPEN SURGERY TO TRANSPOSE THE SUPRA-AORTIC VESSELS WITH A BIFURCATED VASCULAR GRAFT (INTERGARD-K 14/7, MAQUET GETINGEGROUP, RASTATT, GERMANY). THE OPERATION WAS PERFORMED VIA STERNOTOMY WITHOUT CARDIOPULMONARY BYPASS (CPB). THE STENT GRAFT WAS NOT RETRIEVED BECAUSE THE DISTAL EXTREMITY COVERED WELL THE RUPTURED PORTION. AFTER TRANSPOSITION PROCEDURE, THE PROXIMAL END OF ENDOGRAFT WAS SEALED BY BALLOON INFLATION. THE RECOVERY WAS UNEVENTFUL. THE PATIENT PRESENTED NO NEUROLOGICAL DEFICITS, OR DIFFICULTY IN MOVING THE LEFT UPPER ARM. DURING FOLLOW-UP, THE PATIENT DID WELL IN ORDINARY LIFE AS WELL AS IN HIS STUDIES. THE CONTROL IMAGING EXAMS IN 6 MONTHS AND 1 YEAR WERE NORMAL. HOWEVER, 15 MONTHS LATER, HE MANIFESTED SEVERAL PERIODS OF HORIZONTAL DIPLOPIA AND ONE EPISODE OF TRANSIENT PARESIA OF THE RIGHT ARM. THE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THREATENING THROMBOSIS IN THE DEBRANCHING GRAFT. THE PATIENT WAS IMMEDIATELY HOSPITALIZED FOR AN EMERGENT REDO SURGERY. IN THIS REDO SURGERY, WE REMOVED THE THROMBOSED DEBRANCHING GRAFT AS WELL AS PART OF ASCENDING AORTA AND STENT GRAFT; WE RECONSTRUCTED THE AORTIC ARCH WITH A POLYESTER VASCULAR GRAFT (INTERGARD 26) AND TWO DACRON (POLYETHYLENE TEREPHTHALATE) GRAFTS (8 MM). THE REDO OPERATION WAS UNEVENTFUL AND THE RECOVERY WAS FAVORABLE. THE PATIENT WAS TRANSFERRED TO THE ORDINARY WARD ON THE THIRD DAY AND DISCHARGED ON THE EIGHTH DAY. THE CTA AND ECHO-DOPPLER BEFORE DISCHARGE SHOWED PERMEABLE VASCULAR PROSTHESIS WITHOUT COMPLICATIONS. TO DATE, THE PATIENT IS WELL AND WILL BE FOLLOWED REGULARLY IN THE OUTPATIENT CLINIC. ABSTRACT: BACKGROUND THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) HAS BECOME THE TREATMENT OF CHOICE IN THE MANAGEMENT OF THE AORTIC ARCH AND DESCENDING AORTA DISEASES. THROMBOSIS IS A COMMON REASON FOR VASCULAR GRAFT FAILURE, BUT THERE IS NO CONSENSUS ON THE ANTICOAGULATION MANAGEMENT AFTER PLACEMENT OF VASCULAR GRAFT. CASE DESCRIPTION A (B)(6) PATIENT WITH TRAUMATIC RUPTURE OF AORTIC ISTHMUS UNDERWENT REDO OPEN SURGERY FOR TWO SUCCESSIVE COMPLICATIONS: STENT-GRAFT MIGRATION AND PREMATURE DEBRANCHING PROSTHESIS THROMBOSIS. CONCLUSION OPEN SURGERY REMAINS AN EFFICIENT APPROACH WHEN TEVAR IS CONTRAINDICATED OR FAILED. POSTOPERATIVELY PHARMACOLOGICAL PROPHYLAXIS AGAINST VASCULAR GRAFTS¿ THROMBOSIS SHOULD BE EMPHASIZED. THE EXACT DATE OF THE EVENT IS UNKNOWN. THE MONTH AND YEAR ARE VALID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565719 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR Required Intervention