BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 5704598 · Received June 7, 2016

    Report

    Report Number
    2953200-2016-01169
    Event Type
    Injury
    Date Received
    June 7, 2016
    Date of Event
    December 29, 2014
    Report Date
    May 13, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; PATHOLOGY-SPECIFIC LATE OUTCOME AFTER ENDOVASCULAR REPAIR OF THORACIC AORTA: A SINGLE-CENTRE EXPERIENCE CLÉMENCE DUFOUR, DELPHINE GAMONDES, ADELINE MANSUY, JACQUES ROBIN, LOÏC BOUSSEL AND PHILIPPE DOUEK (EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 48 (2015) 923¿930) DOI:10.1093/EJCTS/EZV054 TALENT TAA AND VALIANT STENT GRAFTS WERE IMPLANTED IN THE PATIENT BETWEEN 1999 AND 2007 FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC DISSECTION, TRAUMATIC AORTIC INJURIES, THORACIC AORTA ANEURYSM, PSEUDO-ANEURYSM, AND PENETRATING ULCER. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: INACCURATE DELIVERY, UNINTENTIONAL COVERAGE OF THE SUBCLAVIAN ARTERY, TYPE I ENDOLEAK, TYPE III ENDOLEAK, UNKNOWN ENDOLEAK, MIGRATION, PERIPROSTHETIC ECTASIA, AORTO-OESOPHAGEAL FISTULA, INFECTION, PARAPLEGIA, CEREBROVASCULAR ACCIDENT, SURGICAL AORTIC REPLACEMENT, INTIMO-MEDIAL EROSIONS, FALSE LUMEN PERFUSION, HAEMORRHAGIC SHOCK, MESENTERIC ISCHAEMIA, ANEURYSM RUPTURE, DISSECTION. ABSTRACT OBJECTIVES: ENDOVASCULAR TREATMENT OF THORACIC AORTIC LESIONS APPEARS TO BE ADVANTAGEOUS. HOWEVER, LONG-TERM OUTCOMES REMAIN POORLY REPORTED. THIS RETROSPECTIVE STUDY REPORTED 6-YEAR OUTCOMES OF THORACIC ENDOVASCULAR AORTIC REPAIR. METHODS: A TOTAL OF 74 PATIENTS UNDERWENT ENDOVASCULAR THORACIC AORTA TREATMENTS BETWEEN 1999 AND 2007; 13 HAD THORACIC AORTIC DISSECTIONS, 19 HAD TRAUMATIC AORTIC INJURIES, 35 HAD ANEURYSMS, 6 HAD PSEUDOANEURYSMS AND 1 HAD A PENETRATING ULCER. THE MEAN FOLLOW-UP WAS 66 MONTHS AFTER 30 PERIOPERATIVE DAYS. YEARLY FOLLOW-UPS INCLUDED COMPUTED TOMOGRAPHY ANGIOGRAPHY OR MAGNETIC RESONANCE ANGIOGRAPHY. PATIENT DEMOGRAPHICS, MORTALITY, COMPLICATIONS AND REINTERVENTIONS WERE ANALYSED. RESULTS: THE EARLY 30-DAY MORTALITY AND THE OVERALL LATE MORTALITY WERE 9.5 (7/74) AND 37.8% (28/74), RESPECTIVELY. LATE MORTALITY WAS HIGHER IN PATIENTS WITH ANEURYSMS THAN IN THE OTHER GROUPS (20/35; 57% VS 8/39; 20.5%; P = 0.002). AORTIC-RELATED MORTALITY OCCURRED IN 5/35 (14%) PATIENTS WITH ANEURYSMS, BUT NOT IN OTHER GROUPS (P = 0.02). NO RELATIONSHIPS AMONG LATE COMPLICATIONS WERE FOUND FOR TRAUMATIC AORTIC INJURIES. THE MOST COMMON COMPLICATION WAS AN ENDOLEAK (21/74, 28.4%), WHICH OCCURRED MORE FREQUENTLY WITH ANEURYSMS THAN OTHER DISORDERS (18/35, 51.4% VS 3/39, 7.7%; P <(><<)> 0.001). ENDOLEAKS ALSO OCCURRED MOST FREQUENTLY IN AORTIC-RELATED DEATHS (16/69 VS 5/5; P = 0.001). TYPE 1 ENDOLEAKS OCCURRED SIGNIFICANTLY MORE OFTEN WITH ANEURYSMS (13/35) THAN WITH OTHER DISORDERS (P = 0.004). REINTERVENTION WAS REQUIRED IN 9 PATIENTS (12%); 8 WITH ATHEROSCLEROTIC ANEURYSMS (8/35; 23%). A FALSE LUMEN WAS THROMBOSED IN 54% OF DISSECTIONS (7/13), AND SHRANK IN 39% (5/13). CONCLUSIONS: LONG-TERM OUTCOMES DEPENDED ON AORTIC PATHOLOGY. AORTIC ANEURYSMS WERE THE MOST COMPLICATED AND CAUSED THE HIGHEST MORTALITY, PROBABLY DUE TO ATHEROSCLEROTIC DISEASE EVOLUTION. PATIENTS WITH TRAUMATIC AORTIC INJURIES APPEARED TO HAVE THE BEST LONG-TERM OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356913 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention