BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 4103228 · Received September 19, 2014

    Report

    Report Number
    2953200-2014-01879
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    January 23, 2013
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    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: FIVE-YEAR RESULTS FOR ENDOVASCULAR REPAIR OF ACUTE COMPLICATED TYPE B AORTIC DISSECTION. JENNIFER M. HANNA, MD, MBA,A NICHOLAS D. ANDERSEN, MD,A ASVIN M. GANAPATHI, MD, RICHARD L. MCCANN, MD,B AND G. CHAD HUGHES, MD. (J VASC SURG 2013;-:1-11.) TALENT TAA AND VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM. THE REPORTED COMPLICATIONS REQUIRING EITHER EMERGENT OR ELECTIVE INTERVENTION ARE: TYPE I ENDOLEAK (PROXIMAL AND DISTAL), OCCLUSION, CVA/STROKE, PARALYSIS, RENAL FAILURE, KINK, TYPE II ENDOLEAK, SURGICAL CONVERSION, MI, TYPE A DISSECTION, AND NON-DEVICE RELATED DEATH. INTRODUCTION: DESPITE A CURRENT LACK OF U.S. FOOD AND DRUG ADMINISTRATION APPROVAL FOR THE INDICATION, THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) HAS REPLACED OPEN SURGICAL MANAGEMENT FOR ACUTE COMPLICATED TYPE B AORTIC DISSECTION DUE TO PROMISING SHORT- AND MIDTERM DATA. HOWEVER, LONG-TERM RESULTS, WITH A VIEW TOWARD DURABILITY AND NEED FOR SECONDARY PROCEDURES, ARE LIMITED. AS SUCH, THE OBJECTIVE OF THE PRESENT STUDY IS TO REPORT LONG-TERM OUTCOMES OF TEVAR FOR ACUTE (#2 WEEKS FROM SYMPTOM ONSET) COMPLICATED TYPE B DISSECTION. METHODS: BETWEEN JULY 2005 AND SEPTEMBER 2012, 50 CONSECUTIVE PATIENTS UNDERWENT TEVAR FOR MANAGEMENT OF ACUTE COMPLICATED TYPE B DISSECTION AT A SINGLE REFERRAL INSTITUTION. PATIENT RECORDS WERE RETROSPECTIVELY REVIEWED FROM A PROSPECTIVELY MAINTAINED CLINICAL DATABASE. RESULTS: INDICATIONS FOR INTERVENTION INCLUDED RUPTURE IN 10 (20%), MALPERFUSION IN 24 (48%), AND/OR REFRACTORY PAIN/IMPENDING RUPTURE IN 17 (34%). ONE PATIENT (2%) HAD BOTH RUPTURE AND MALPERFUSION INDICATIONS. TEN (20%) PATIENTS REQUIRED ONE OR MORE ADJUNCTIVE PROCEDURES, IN ADDITION TO TEVAR, TO TREAT MALPERFUSION SYNDROMES. IN-HOSPITAL AND 30-DAY RATES OF DEATH WERE BOTH 0%; 30-DAY/IN-HOSPITAL RATES OF STROKE, PERMANENT PARAPLEGIA/PARAPARESIS, AND NEW-ONSET DIALYSIS WERE 2% (N [ 1), 2% (N [ 1), AND 4% (N [ 2), RESPECTIVELY. MEDIAN FOLLOW-UP WAS 33.8 MONTHS [INTERQUARTILE RANGE, 12.3-56.6 MONTHS]. OVERALL SURVIVAL AT 5 AND 7 YEARS WAS 84%, WITH NO DEATHS ATTRIBUTABLE TO AORTIC PATHOLOGY. THIRTEEN (26%) PATIENTS REQUIRED A TOTAL OF 17 REINTERVENTIONS OVER THE STUDY PERIOD FOR TYPE I ENDOLEAK (N [ 5), METACHRONOUS AORTIC PATHOLOGY (N [ 5), PERSISTENT FALSE LUMEN PRESSURIZATION VIA DISTAL FENESTRATIONS (N [ 4), TYPE II ENDOLEAK (N [ 2), OR RETROGRADE ACUTE TYPE A AORTIC DISSECTION (N [ 1). MEDIAN TIME TO FIRST REINTERVENTION WAS 4.5 MONTHS (RANGE, 0 DAYS-40.3 MONTHS). OF THE 17 TOTAL REINTERVENTIONS, SIX (35%) WERE PERFORMED USING OPEN TECHNIQUES AND 11 (65%) WITH ENDOVASCULAR OR HYBRID METHODS; THERE WAS NO DIFFERENCE IN SURVIVAL BETWEEN PATIENTS WHO DID OR DID NOT REQUIRE REINTERVENTION. CONCLUSIONS: THIS STUDY CONFIRMS THE EXCELLENT SHORT-TERM OUTCOMES OF TEVAR FOR ACUTE COMPLICATED TYPE B DISSECTION AND DEMONSTRATES THE RESULTS TO BE DURABLE AND SUSTAINED OVER LONG-TERM FOLLOW-UP. ALTHOUGH AORTIC REINTERVENTIONS WERE REQUIRED IN ONE-QUARTER OF PATIENTS, NO AORTIC-RELATED DEATHS WERE OBSERVED. THESE DATA SUPPORT THE USE OF TEVAR FOR ACUTE COMPLICATED TYPE B AORTIC DISSECTION BUT ALSO HIGHLIGHT THE IMPORTANCE OF LIFE-LONG AORTIC SURVEILLANCE BY AN EXPERIENCED AORTIC REFERRAL CENTER IN ORDER TO IDENTIFY AND TREAT COMPLICATIONS OF THE UNDERLYING DISEASE PROCESS AND TREATMENT, AS WELL AS NEW AORTIC PATHOLOGIES, AS THEY ARISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582167 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention