BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3214050 · Received July 9, 2013

    Report

    Report Number
    2953200-2013-01289
    Event Type
    Death
    Date Received
    July 9, 2013
    Date of Event
    September 23, 2008
    Report Date
    June 13, 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 (DEATH, ENDOLEAK, DISSECTION, ANEURYSM RUPTURE, SURGICAL CONVERSION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY DISSECTED THORACIC AORTA). CONCLUSION: INHERENT RISK OF A PROCEDURE (DEATH, ENDOLEAK, DISSECTION, ANEURYSM RUPTURE, SURGICAL CONVERSION); DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY DISSECTED THORACIC AORTA).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: ENDOVASCULAR REPAIR OR MEDICAL TREATMENT OF ACUTE TYPE B AORTIC DISSECTION? A COMPARISON. EUROPEAN JOURNAL OF RADIOLOGY 73 (2010) 175¿180. ON AN UNKNOWN DATE UNKNOWN TALENT THORACIC STENT GRAFTS WERE IMPLANTED BETWEEN JULY 1996 TO APRIL 2008. INTRODUCTION: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE OUTCOME OF THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) TO THAT OF MEDICAL THERAPY IN PATIENTS WITH ACUTE TYPE B AORTIC DISSECTION (TBD). MATERIALS AND METHODS: FROM JULY 1996 TO APRIL 2008, 88 PATIENTS PRESENTING WITH ACUTE TBD UNDERWENT EITHER TEVAR (GROUP A, N = 38) OR MEDICAL THERAPY (GROUP B, N = 50). INDICATIONS FOR TEVAR WERE INTRACTABLE PAIN, AORTIC BRANCH COMPROMISE RESULTING IN END-ORGAN ISCHEMIA, RAPID AORTIC DILATATION AND RUPTURE. FOLLOW-UP WAS PERFORMED POST INTERVENTION, AT 3,6 AND 12 MONTHS AND YEARLY THEREAFTER AND INCLUDED CLINICAL EXAMINATIONS AND COMPUTED TOMOGRAPHY (CT), AS WELL AS AORTIC DIAMETER MEASUREMENTS AND ASSESSMENT OF THROMBOSIS. RESULTS: MEAN FOLLOW-UP WAS 33 MONTHS IN GROUP A AND 36 MONTHS IN GROUP B. THE OVERALL MORTALITY RATE WAS 23.7% IN GROUP A AND 24% IN GROUP B, WHERE 4 PATIENTS DIED OF LATE AORTIC RUPTURE. IN GROUP A, COMPLICATIONS INCLUDED 9 ENDOLEAKS AND 4 RETROGRADE TYPE A DISSECTIONS, 3 PATIENTS WERE CONVERTED TO OPEN SURGERY AND 2 NEEDED SECONDARY INTERVENTION. NONE OF THE PATIENTS DEVELOPED PARAPLEGIA. IN GROUP B, 4 PATIENTS WERE CONVERTED TO OPEN SURGERY AND 2 TO TEVAR. THE MAXIMAL AORTIC DIAMETER INCREASED IN BOTH GROUPS. REGARDING THE EXTENT OF THROMBOSIS, OUR ANALYSES SHOWED SLIGHTLY BETTER OVERALL RESULTS AFTER TEVAR, BUT THEY ALSO SHOWED A TENDENCY TOWARDS APPROXIMATION BETWEEN THE TWO GROUPS DURING FOLLOW-UP. CONCLUSION: TEVAR IS A FEASIBLE TREATMENT OPTION IN ACUTE TBD. HOWEVER, SEVERAL SERIOUS COMPLICATIONS MAY OCCUR DURING AND AFTER TEVAR AND IT SHOULD THEREFORE BE RESERVED TO PATIENTS WITH LIFE-THREATENING SYMPTOMS. THE FOLLOWING EVENTS WERE REPORTED IN THE JA. DISSECTION, SURGICAL CONVERSION, DEATH (CAUSE UNKNOWN), RUPTURE, ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313134 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention