BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 5079620 · Received September 15, 2015

    Report

    Report Number
    2953200-2015-01565
    Event Type
    Injury
    Date Received
    September 15, 2015
    Date of Event
    April 21, 2015
    Report Date
    August 24, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT DATES OF THE EVENTS ARE UNKNOWN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; MODIFIED PETTICOAT TECHNIQUE WITH PRE-PLACEMENT OF A DISTAL BARE STENT IMPROVES EARLY AORTIC REMODELING AFTER COMPLICATED ACUTE STANFORD TYPE B AORTIC DISSECTION H. HE, K. YAO, W.P. NIE, Z. WANG, Q. LIANG, C. SHU, A. DARDIK (EUR J VASC ENDOVASC SURG (2015), 1-10) A TALENT TAA STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF THORACIC ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE NOTED: TYPE I ENDOLEAK, PARAPLEGIA, RENAL FAILURE, RUPTURE, DISSECTION, SURGICAL CONVERSION, TYPE A DISSECTION, TYPE III ENDOLEAK. OBJECTIVE: THIS STUDY EVALUATES THE SAFETY AND EFFICACY OF PRE-PLACEMENT OF A DISTAL BARE STENT AS AN ADJUNCT TO THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) IN THE SETTING OF COMPLICATED ACUTE STANFORD TYPE B AORTIC DISSECTION (CTBAD). METHODS: THE RECORDS OF ALL PATIENTS DIAGNOSED WITH CTBAD AT THE INSTITUTION BETWEEN 2010 AND 2013 WERE REVIEWED. INDICATIONS FOR THE PRE-PLACEMENT OF A DISTAL BARE STENT INCLUDED SYMPTOMATIC MALPERFUSION AND/OR RADIOLOGICAL EVIDENCE OF TRUE LUMEN COLLAPSE. COMPUTED TOMOGRAPHY ANGIOGRAPHY WAS PERFORMED POSTOPERATIVELY TO ASSESS AORTIC REMODELING. RESULTS: 148 PATIENTS WERE TREATED FOR CTBAD: 113 PATIENTS (76.4%) WERE TREATED WITH STANDARD TEVAR AND 35 (23.6%) WERE TREATED BY COMBINED PROXIMAL TEVAR WITH PRE-PLACEMENT OF AN ADJUNCTIVE DISTAL BARE STENT. PRIMARY TECHNICAL SUCCESS WAS 95.9%. THE 30 DAY MORTALITY RATE WAS 4.1% AND WAS NOT DIFFERENT BETWEEN GROUPS. THE 30 DAY MORBIDITY INCLUDED TRANSIENT RENAL FAILURE (10.1%), ENDOLEAK (7.4%), AND PARAPLEGIA (2.7%), AND WAS NOT DIFFERENT BETWEEN GROUPS. THE MEAN FOLLOW UP WAS 10 MONTHS (RANGE 2E12 MONTHS). NO LATE STENT COMPLICATIONS WERE OBSERVED; PATIENTS WITH AN ADJUNCTIVE BARE STENT HAD LESS DISTAL RE-DISSECTION (0% VS. 15%; P 1/4.01) AND FEWER ENDOVASCULAR RE-INTERVENTIONS (5.7% VS. 20.4%; P 1/4.04). AT 1 YEAR, PATIENTS TREATED WITH TEVAR AND AN ADJUNCTIVE DISTAL BARE STENT HAD INCREASED TRUE LUMEN VOLUME (166 VS. 110 ML; P 1/4.022), DECREASED FALSE LUMEN VOLUME (60 VS. 90 ML; P 1/4.043), AND INCREASED COMPLETE FALSE LUMEN THROMBOSIS IN THE THORACIC (76.5% VS. 29.5%; P <(><<)> .001) AND ABDOMINAL (20.6% VS. 3.8%; P 1/4.002) SEGMENTS. CONCLUSIONS: COMBINED PRE-PLACEMENT OF A DISTAL BARE STENT AS AN ADJUNCT TO PROXIMAL TEVAR TO TREAT CTBAD RESTRICTS OVERSIZING OF THE DISTAL STENT GRAFT, REDUCING THE POTENTIAL FOR DISTAL TRUE LUMEN COLLAPSE AND VISCERAL MALPERFUSION, AND IMPROVING REMODELING OF THE DISSECTED THORACIC AORTA. LONG-TERM FOLLOW UP AND PROSPECTIVE STUDIES ARE NEEDED TO ASSESS THE OVERALL EFFECTIVENESS OF THIS TREATMENT STRATEGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610547 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention