BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3214071 · Received July 9, 2013

    Report

    Report Number
    2953200-2013-01290
    Event Type
    Death
    Date Received
    July 9, 2013
    Date of Event
    April 19, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (DEATH, ENDOLEAK, DISSECTION, ANEURYSM RUPTURE, OCCLUSION, STROKE, MI, RENAL FAILURE, BLEEDING, FEVER); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY DISSECTED THORACIC AORTA). CONCLUSION: INHERENT RISK OF A PROCEDURE (DEATH, ENDOLEAK, DISSECTION, ANEURYSM RUPTURE, OCCLUSION, STROKE, MI, RENAL FAILURE, BLEEDING, FEVER); 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: COMPARISON OF LONG-TERM CLINICAL OUTCOME BETWEEN PATIENTS WITH CHRONIC VERSUS ACUTE TYPE B AORTIC DISSECTION TREATED BY IMPLANTATION OF A STENT GRAFT: A SINGLE-CENTER REPORT. PREFERENCE AND ADHERENCE 19 APRIL 2013. 2013:7 319¿327 ON AN UNKNOWN DATE UNKNOWN TALENT THORACIC STENT GRAFTS (PLI 10) WERE IMPLANTED BETWEEN MAY 2000 AND JUNE 2011. BACKGROUND: STENT GRAFTING FOR TREATMENT OF TYPE B AORTIC DISSECTION HAS BEEN EXTENSIVELY USED. HOWEVER, THE DIFFERENCE IN THE LONG-TERM CLINICAL OUTCOME BETWEEN PATIENTS WITH CHRONIC VERSUS ACUTE TYPE B AORTIC DISSECTION REMAINS UNKNOWN. THIS STUDY AIMED TO ANALYZE THE DIFFERENCE IN LONG-TERM CLINICAL OUTCOME AFTER ENDOVASCULAR REPAIR FOR PATIENTS WITH CHRONIC (GREATER THAN OR EQUAL TO 2 WEEKS) VERSUS ACUTE (LESS THAN 2 WEEKS) TYPE B AORTIC DISSECTION. METHODS: BETWEEN MAY 2000 AND JUNE 2011, A TOTAL OF 174 PATIENTS WITH TYPE B AORTIC DISSECTION (56 CHRONIC, 118 ACUTE) TREATED BY ENDOVASCULAR REPAIR WERE STUDIED PROSPECTIVELY. FOLLOW-UP THREE-DIMENSIONAL COMPUTED TOMOGRAPHY SCANNING AND AORTO ANGIOGRAPHY WERE SCHEDULED AT 3¿6 MONTHS AFTER THE INDEX PROCEDURE. PROPENSITY SCORE MATCHING WAS USED TO COMPARE THE DIFFERENCE IN THE ENDPOINT BETWEEN THE TWO GROUPS. RESULTS: THE PROCEDURE-RELATED EVENT RATE WAS 18.6% IN THE ACUTE GROUP AND 5.4% IN THE CHRONIC GROUP (P = 0.021), BUT THIS DIFFERENCE BECAME NON-SIGNIFICANT AFTER PROPENSITY SCORE MATCHING. AT THE END OF FOLLOW-UP (MEAN 2.49 YEARS), OVERALL AND AORTA-RELATED MORTALITY WAS 11.0% AND 7.6%, RESPECTIVELY, IN THE ACUTE GROUP, AND WAS NOT SIGNIFICANTLY DIFFERENT FROM THAT IN THE CHRONIC GROUP (3.6% AND 3.6%, P = 0.148 AND P = 0.506, RESPECTIVELY). BOTH FALSE AND TRUE LUMINA SHOWED SIGNIFICANT REMODELING OVER TIME, WITH .93% COMPLETE FALSE-LUMEN THROMBOSIS. UNTREATED TEAR AND TYPE I ENDOLEAK WERE PREDICTORS OF CLINICAL EVENTS DURING FOLLOW-UP. CONCLUSION: COMPARABLE LONG-TERM CLINICAL RESULTS WERE ACHIEVED IN PATIENTS WITH CHRONIC OR ACUTE TYPE B AORTIC DISSECTION AFTER IMPLANTATION OF A STENT GRAFT. THE FOLLOWING EVENTS WERE REPORTED: DISSECTION, DEATH, RUPTURE, TYPE I ENDOLEAK, OCCLUSION, STROKE, MI, RENAL FAILURE, BLEEDING, FEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312653 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention