BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA

    MDR report key: 3689203 · Received March 19, 2014

    Report

    Report Number
    2953200-2014-00551
    Event Type
    Injury
    Date Received
    March 19, 2014
    Date of Event
    November 25, 2013
    Report Date
    March 4, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: ENDOVASCULAR REPAIR OF THE ASCENDING AORTA: WHEN AND HOW TO IMPLEMENT THE CURRENT TECHNOLOGY. OURANIA PREVENTZA, MD, MATTHEW J. HENRY, MD, BENJAMIN Y. C. CHEONG, MD, AND JOSEPH S. COSELLI, MD. ANN THORAC SURG 2014; ACCEPTED ON (B)(6) 2013 THE FOLLOWING EVENTS WERE OBSERVED IN THIS JOURNAL ARTICLE. ONE PATIENT REQUIRED A SELF-EXPANDING TALENT STENT GRAFT (MEDTRONIC, (B)(4)) AND THEN AN ADDITIONAL GORE TAG ENDOGRAFT TO SEAL AN INTRAOPERATIVE ENDOLEAK. A NON-ST ELEVATION MYOCARDIAL INFARCTION DEVELOPED IN 1 PATIENT POSTOPERATIVELY. THE PATIENT RECOVERED, BUT ACUTE-ON-CHRONIC ISCHEMIA OF THE RIGHT LOWER EXTREMITY REQUIRED EMBOLECTOMY OF THE RIGHT PROFUNDA FEMORIS AND SUPERFICIAL FEMORAL ARTERIES AND PATCH ANGIOPLASTY OF THE EXTERNAL ILIAC AND COMMON FEMORAL ARTERY. THERE IS NO FURTHER INFORMATION AVAILABLE. BACKGROUND. THE PURPOSE OF OUR STUDY WAS TO EXAMINE WHEN AND HOW TO IMPLEMENT THE CURRENT ENDOLUMINAL STENT GRAFT TECHNOLOGY TO TREAT ASCENDING AORTIC DISEASE. METHODS. DURING A 7-YEAR PERIOD (MARCH 2006 THROUGH JULY 2013), 7 CONSECUTIVE PATIENTS (MEDIAN AGE, 69 YEARS; RANGE, 61.5 TO 80.5 YEARS) WITH MULTIPLE COMORBIDITIES UNDERWENT ENDOLUMINAL REPAIR OF THE ASCENDING AORTA. SIX HAD AN ASCENDING AORTIC PSEUDOANEURYSM, AND 1 HAD IATROGENIC COARCTATION. THE MEDIAN NUMBER OF PRIOR STERNOTOMIES WAS 2 (RANGE, 1 TO 4). RESULTS. TECHNICAL SUCCESS WAS ACHIEVED IN ALL BUT 1 PATIENT, WITH 1 DEATH (14.3%) AT 30 DAYS. THE ENDOLUMINAL TECHNOLOGY USED INCLUDED THE GORE TAG (W.L. GORE AND ASSOCIATES, (B)(4)) THORACIC GRAFT (INCLUDING THE NEW C-TAG) IN 6 PATIENTS, THE TALENT STENT GRAFT (MEDTRONIC, (B)(4)) IN 1, AN EXCLUDER CUFF (W.L. GORE) IN 2, AND AN AMPLATZER OCCLUDER (AGA MEDICAL CORP, PLYMOUTH, MN) IN 1. MORE THAN 1 STENT WAS PLACED IN 4 PATIENTS. THREE PATIENTS REQUIRED INNOMINATE ARTERY STENTING, AND 1 REQUIRED ADDITIONAL LEFT COMMON CAROTID ARTERY STENTING. ONE PATIENT (14.3%) REQUIRED INTRAOPERATIVE CONVERSION TO OPEN SURGICAL REPAIR. MEDIAN FOLLOW-UP WAS 14.4 MONTHS (INTERQUARTILE [25TH TO 75TH PERCENTILE] RANGE, 5.5 TO 22.6 MONTHS) WITH 66.6% OVERALL SURVIVAL. NO AORTIC-RELATED DEATH WAS REPORTED DURING THE FOLLOW-UP PERIOD. CONCLUSIONS. STENT GRAFTING OF THE ASCENDING AORTA IS FEASIBLE BUT LIMITED AND IS RESERVED FOR HIGH-RISK INDIVIDUALS. TECHNICAL EXPERTISE IS ESSENTIAL, AND FOLLOW-UP IS MANDATORY. TECHNICAL POINTS, TIPS, AND CHALLENGES OF THE CURRENT ENDOVASCULAR TECHNOLOGY TO EFFECTIVELY TREAT THE ASCENDING AORTA ARE DESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162640 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention