BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 3211805 · Received July 8, 2013

    Report

    Report Number
    2953200-2013-01277
    Event Type
    Death
    Date Received
    July 8, 2013
    Date of Event
    April 1, 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
    SZ
    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 (ENDOLEAK, DEATH, OCCLUSION, DISSECTION, RUPTURE); (UNKNOWN CAUSE OF EVENT); FAILURE TO FOLLOW INSTRUCTIONS (COVERING THE INNOMINATE AND COMMON CAROTID ARTERY). CONCLUSION: (UNKNOWN CAUSE OF EVENT); OFF ¿LABEL, UNAPPROVED OR CONTRAINDICATED USE (COVERING THE INNOMINATE AND COMMON CAROTID ARTERY) KNOWN INHERENT RISK OF A PROCEDURE (ENDOLEAK, DEATH, OCCLUSION, DISSECTION, RUPTURE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: MIDTERM RESULTS OF THORACIC ENDOVASCULAR AORTIC REPAIR IN PATIENTS WITH ANEURYSMS INVOLVING THE DESCENDING AORTA ORIGINATING FROM CHRONIC TYPE B DISSECTIONS. MARTIN CZERNY, MD, S UZANNE ROEDLER, MD, SETAREH FAKHIMI, MD, MEDICAL UNIVERSITY OF VIENNA; AND DEPARTMENT OF CARDIOLOGY, KRANKENANSTALT RUDOLFSTIFTUNG, VIENNA, AUSTRIA (ANN THORAC SURG 2010;90:90¿4) ON AN UNKNOWN DATE BETWEEN 2004 AND 2009, AN UNKNOWN TALENT STENT GRAFT AND AN UNKNOWN VALIANT STENT GRAFT WERE IMPLANTED. DURING A RETROSPECTIVE STUDY OF 14 PATIENTS TREATED FOR ANEURYSMS INVOLVING THE DESCENDING AORTA ORIGINATING FROM CHRONIC TYPE B DISSECTIONS, THE FOLLOWING EVENTS WEREOBSERVED: PRE-OP DISSECTION, INTENTIONAL VESSEL COVERAGE, THROMBOSIS, TYPE 1A ENDOLEAK, DISSECTION, POST-OP RUPTURE, MI, DEATH (INSUFFICIENT INFO), STENT GRAFT CRIMPING (INFOLDING), UNKNOWN ENDOLEAK. NO ADDITIONAL INFORMATION IS AVAILABLE. BACKGROUND. MIDTERM RESULTS OF TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) IN PATIENTS WITH ANEURYSMS INVOLVING THE DESCENDING AORTA ORIGINATING FROM CHRONIC TYPE B DISSECTIONS ARE NOT KNOWN. METHODS. BETWEEN 2004 AND 2009, 14 PATIENTS WITH A MEDIAN AGE OF 63 YEARS (79% MALE) WITH THIS PATHOLOGY WERE TREATED. SEVEN PATIENTS UNDERWENT SUPRAAORTIC TRANSPOSITIONS IN VARIOUS EXTENTS PRIOR TO TEVAR IN ORDER TO GAIN A SUFFICIENT PROXIMAL LANDING ZONE. RESULTS. MEDIAN TIME FROM DISSECTION TO TREATMENT WAS 19 MONTHS (4 TO 84 MONTHS). ALL PATIENTS HAD AN UNEVENTFUL IN-HOSPITAL COURSE. THE MEDIAN COVERED LENGTH OF THE AORTIC ARCH AND DESCENDING AORTA WAS 190 MM (100 TO 250 MM). PRIMARY SUCCESS RATE DEFINED AS ABSENCE OF TYPE IA ENDOLEAKAGE WAS 86%. NO PATIENT, WHERE VISCERAL OR RENAL VESSELS ORIGINATED FROM THE FALSE OR FROM BOTHLUMINA SUSTAINED ISCHEMIC INJURY BY TEVAR. THE MEDIAN FOLLOW- UP PERIOD IS 34 MONTHS TO DATE (6 TO 64 MONTHS). AORTIC-RELATED MORBIDITY AND MORTALITY DURING FOLLOW-UP WAS LOW (14%). CONCLUSIONS. MIDTERM RESULTS OF TEVAR IN PATIENTS WITH ANEURYSMS INVOLVING THE DESCENDING AORTA ORIGINATING FROM CHRONIC TYPE B DISS ECTIONS ARE GOOD. THE SELFEXPANDING CAPABILITY OF THE STENT GRAFTS IS SUFFICIENTOVER TIME. HOWEVER, EXTENSIVE COVERAGE OF THE DESCENDING AORTA IS WARRANTED TO ACHIEVE SUCCESS. FURTHER STUDIES ARE NEEDED TO EXTEND OUR KNOWLEDGE IN THIS PARTICULAR SUBGROUP OF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308881 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Death