BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3145841 · Received June 4, 2013

    Report

    Report Number
    2953200-2013-01055
    Event Type
    Death
    Date Received
    June 4, 2013
    Date of Event
    January 1, 1996
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (CVA/STROKE, DEATH, PARALYSIS, RENAL FAILURE, RUPTURE, DISSECTION, PERFORATION, ENDOLEAK, SURGICAL CO NVERSION, REMOVAL OF IMPLANT, ) PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVE ANEURYSM RUPTURE AND PRE-OPERATIVE DISSECTION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVE ANEURYSM RUPTURE AND PRE-OPERATIVE DISSECTION).

    Description of Event or Problem · 1

    THE EVENT WAS ENTERED INTO A STAGING RECORD FROM TECHNICAL SERVICES. JOURNAL ARTICLE: THORACIC ENDOVASCULAR AORTIC REPAIR IN 300 PATIENTS: LONG-TERM RESULTS DOMINIK WIEDEMANN, MD, STEPHANE MAHR, MD, AMIT VADEHRA, MS, MARIA SCHODER, MD, MARTIN FUNOVICS, MD, CHRISTIAN L¿OWE, MD, CHRISTINA PLANK, MD, JOHANNES LAMMER, MD, G¿UNTHER LAUFER, MD, MARIE-ELISABETH STELZM¿ULLER, MD, ALFRED KOCHER, MD, AND MAREK P. EHRLICH, M. DEPARTMENTS OF CARDIAC SURGERY AND INTERVENTIONAL RADIOLOGY, MEDICAL UNIVERSITY OF VIENNA, VIENNA, AUSTRIA. ANN THORAC SURG 2013;95:1577¿83 A TALENT STENT GRAFT SYSTEM WAS USED FOR THE TREATMENT OF 47 DTA (DESCENDING THORACIC AORTIC ANEURYSM; DIAMETER OF OVER 55 MM;), 20 PAU (PERFORATING AORTIC ULCER, FOCAL BULGE OF CONTRAST THROUGH AN INTIMAL CALCIFICATION OF THE AORTA), 39 TBD (TYPE B DISSECTION; COMPLICATED AND UNCOMPLICATED ACUTE, AND CHRONIC), AND 16 ATAT (ACUTE TRAUMATIC TRANSECTION) ON UNKNOWN DATES. BACKGROUND. THE AIM OF THIS ANALYSIS WAS TO ASSESS SHORT AND MID-TERM RESULTS OF PATIENTS UNDERGOING THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR 4 DIFFERENT INDICATIONS. METHODS. FROM 1996 TO 2010, 300 PATIENTS (80 FEMALE, 220 MALE, MEDIAN AGE 67 YEARS [20 TO 88]) UNDERWENT TEVAR AT OUR DEPARTMENT. AMONG THEM WERE 137 DESCENDING THORACIC ANEURYSMS (DTA), 80 TYPE B DISSECTIONS (60 ACUTE, 20 CHRONIC), 59 PERFORATING AORTIC ULCER (PAU), AND 24 TRAUMATIC AORTIC TRANSECTIONS (ATAT). HOSPITAL MORTALITY AND MID-TERM SURVIVAL AMONG DIFFERENT INDICATIONS FOR TEVAR WERE EVALUATED. RESULTS. OVERALL HOSPITAL MORTALITY IN OUR SERIES WAS 5% (N [ 15). SEVEN PATIENTS WITH DTA (5%), 4 PATIENTS WITH TYPE B DISSECTIONS (5%), 2 PATIENTS WITH PAU (3.4%), AND 2 ATAT (8%) PATIENTS DIED DURING THEIR HOSPITAL STAY. KAPLAN-MEIER SURVIVAL ANALYSIS REVEALED SIGNIFICANT DIFFERENCES IN SURVIVAL RATES ACCORDING TO THE VARIOUS INDICATIONS FOR TEVAR (P <(><<)> 0.001). OVERALL LONGTERM MORTALITY WAS 86%, 63%, AND 44% AT 1, 5, AND 10 YEARS. EARLY AND LATE ENDOLEAK RATE WAS 18% AND 8%, RESPECTIVELY. CONCLUSIONS. THE TEVAR HAS EVOLVED INTO A SAFE AND EFFECTIVE THERAPY FOR DIFFERENT AORTIC PATHOLOGY RESULTING IN PROMISING LONG-TERM RESULTS. NEVERTHELESS, THE INDICATION FOR TEVAR HAS DIRECT IMPACT ON THE SUCCESS OF THE PROCEDURE. PATIENTS WITH ACUTE TYPE B AORTIC DISSECTIONS AND ACUTE TRAUMATIC AORTIC LESIONS SEEM TO BENEFIT THE MOST FROM TEVAR. PATIENT MORPHOLOGY WAS REPORTED AS 6 PATIENTS WERE PREVIOUSLY TREATED FOR TYPE A DISSECTION; 26 PATIENTS HAD UNDERGONE ABDOMINAL AORTIC SURGERY. A CT REVEALED THAT 57 PATIENTS HAD SIGNS OF AORTIC RUPTURE PRIOR TO THE TEVAR PROCEDURE. THE PATIENTS WERE FOLLOWED BY CT ANGIOGRAPHY EXAMINATIONS WITHIN 3 DAYS OF THE PROCEDURE, AT 3, 6, AND 12 MONTHS, AND YEARLY THEREAFTER. INJURY OF THE INTIMA BY THE BARE SPRINGS OF THESTENT-GRAFT DEVICE IS SUSPECTED TO BE THE CAUSE FOR THIS COMPLICATION. THREE PATIENTS THAT WERE TREATED FOR AORTIC DISSECTION HAD INJURY TO THE INTIMA BY THE BARE SPRING. (BASED ON THIS EXPERIENCE, THE DEVELOPMENT OF SPECIALLY DESIGNED STENT GRAFTS FOR AORTIC DISSECTION IS WARRANTED)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246481 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Death| R