BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3211807 · Received July 8, 2013

    Report

    Report Number
    2953200-2013-01278
    Event Type
    Death
    Date Received
    July 8, 2013
    Date of Event
    June 11, 2010
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC IRELAND
    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

    DATE OF DEATH IS UNKNOWN. DATE OF EVENT IS UNKNOWN. (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH, ENDOLEAK, ISCHEMIA, PARALYSIS, RUPTURE, DISSECTION, OCCLUSION); (UNKNOWN CAUSE OF EVENT); FAILURE TO FOLLOW INSTRUCTIONS (TREATING A PATIENT WITH MARFAN¿S SYNDROME). CONCLUSION: (UNKNOWN CAUSE OF EVENT); KNOWN INHERENT RISK OF A PROCEDURE (DEATH, ENDOLEAK, ISCHEMIA, PARALYSIS, RUPTURE, DISSECTION, OCCLUSION); FAILURE TO FOLLOW INSTRUCTIONS (TREATING A PATIENT WITH MARFAN¿S SYNDROME).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: MIDTERM RESULTS AFTER ENDOVASCULAR TREATMENT OF ACUTE, COMPLICATED TYPE B AORTIC DISSECTION. MAREK P. EHRLICH, MD, JULIA DUMFARTH, MD, UNIVERSITY OF VIENNA, AND DEPARTMENT OF CARDIOLOGY, HOSPITAL RUDOFSTIFTUNG, VIENNA, AUSTRIA (ANN THORAC SURG 2010;90:1444¿9) ON AN UNKNOWN DATE BETWEEN JANUARY 2001 AND FEBRUARY 2010, AN UNKNOWN TALENT STENT GRAFT AND AN UNKNOWN VALIANT STENT GRAFT WERE IMPLANTED. DURING A RETROSPECTIVE STUDY OF 32 PATIENTS TREATED FOR EMERGENCY ENDOVASCULAR STENT GRAFTING FOR COMPLICATED ACUTE TYPE B AORTIC DISSECTION, THE FOLLOWING EVENTS WERE OBSERVED: PRE-OP DISSECTION, PRE-OP RUPTURE, INTENTIONAL VESSEL COVERAGE, RETROGRADE TYPE A DISSECTION, DEATH, BOWEL ISCHEMIA, PARAPARESIS/HEMIPARESIS, TYPE 1A ENDOLEAK (ACUTE), BYPASS, POST-OP RUPTURE, MISALIGNED STENT GRAFT, SPINAL CORD ISCHEMIA, SUBCLAVIAN STEAL SYNDROME, MULTI-ORGAN FAILURE, OBSTRUCTION OF TRUE LUMEN, HEMATOTHORAX. NO ADDITIONAL INFORMATION IS AVAILABLE. BACKGROUND. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE EFFICACY AND MIDTERM RESULTS OF ENDOVASCULAR TREATMENT OF ACUTE, COMPLICATED TYPE B AORTIC DISSECTION. METHODS. BETWEEN JANUARY 2001 AND FEBRUARY 2010, 32 PATIENTS (7 WOMEN, 25 MEN) WITH ACUTE, COMPLICATED TYPE B AORTIC DISSECTION (MEAN AGE, 56 YEARS; RANGE, 35 TO 83 YEARS), DEFINED ASEITHER AORTIC RUPTURE, MALPERFUSION, INTRACTABLE PAIN, OR UNCONTROLLED HYPERTENSION, UNDERWENT ENDOVASCULAR STENT GRAFT PLACEMENT WITH EITHER THE GORE EXCLUDER/TAG DEVICE (N =11), MEDTRONIC TALENT/ VALIANT DEVICE (N =16), BOLTON RELAY (N = 2), OR A COMBINATION OF THESE STENTS (N = 3). FOLLOW-UP WAS 94% COMPLETE AND AVERAGED 26 ± 23 MONTHS. RESULTS. TECHNICAL FEASIBILITY AND SUCCESS WITH DEPLOYMENT PROXIMAL TO THE ENTRY TEAR WAS 87%, REQUIRING PARTIAL OR TOTAL COVERAGE OF THE LEFT SUBCLAVIAN ARTERY (LSA) IN 9 PATIENTS (28%). HOSPITAL MORTALITY WAS 12% ± 11% (95% CONFIDENCE LIMIT) WITH 2 LATE DEATHS (17 AND 98 MONTHS AFTER IMPLANT). CAUSES OF HOSPITAL DEATH INCLUDED RUPTURE IN 2, RETROGRADE TYPE A DISSECTION IN 1, AND MULTIORGAN FAILURE IN 1 PATIENT. THREE PATIENTS (11%) EXPERIENCED NEW NEUROLOGIC COMPLICATIONS (2 PARAPARESIS AND 1 HEMIPARESIS). SIX PATIENTS WITH MALPERFUSION REQUIRED BRANCH VESSEL STENTING. FURTHERMORE, 2 HAD AN EARLY TYPE IA ENDOLEAK. ACTUARIAL SURVIVAL AT 1 AND 5 YEARS WAS 81% AND 76%, RESPECTIVELY. FREEDOM FROM TREATMENT FAILURE AT 1 AND 5 YEARS (INCLUDING REINTERVENTION, AORTIC RUPTURE, DEVICE-RELATED COMPLICATION, AND AORTIC RELATED DEATH) WAS 78% AND 61%, RESPECTIVELY. CONCLUSIONS. ENDOVASCULAR STENT-GRAFT PLACEMENT IN ACUTE, COMPLICATED TYPE B AORTIC DISSECTION PROVES TO BE A PROMISING ALTERNATIVE THERAPEUTIC TREATMENT MODALITY IN THIS RELATIVELY DIFFICULT PATIENT COHORT. REFINEMENTS, ESPECIALLY IN STENT DESIGN AND APPLICATION, MAY FURTHER IMPROVE THE PROGNOSIS OF PATIENTS IN THIS LIFE-THREATENING SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308894 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Death