BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 3211525 · Received July 8, 2013

    Report

    Report Number
    2953200-2013-01274
    Event Type
    Death
    Date Received
    July 8, 2013
    Date of Event
    July 18, 2011
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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, CVA, OCCLUSION, DISSECTION, ISCHEMIA, PARALYSIS, RUPTURE); OTHER (UNKNOWN CAUSE OF EVENT). CONCLUSION: (UNKNOWN CAUSE OF EVENT); KNOWN INHERENT RISK OF A PROCEDURE (ENDOLEAK, DEATH, CVA, OCCLUSION, DISSECTION, ISCHEMIA, PARALYSIS, RUPTURE).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: THORACIC ENDOVASCULAR AORTIC REPAIR: EVOLUTION OF THERAPY, PATTERNS OF USE, AND RESULTS IN A 10-YEAR EXPERIENCE. NIMESH D. DESAI, MD, PHD, ALBERTO POCHETTINO, MD, WILSON Y.SZETO, MD, G. WILLIAM MOSER, MSN, PATRICK J. MOELLER, BSC, NISHTHA SODHI, MD, BENJAMIN JACKSON, MD, EDWARD WOO, MD, RONALD M. FAIRMAN, MD, AND JOSEPH BAVARIA, MD; (J THORAC CARDIOVASC SURG 2011;142:587-94) ON AN UNKNOWN DATE BETWEEN APRIL 1999 AND APRIL 2009, AN UNKNOWN TALENT STENT GRAFT AND AN UNKNOWN VALIANT STENT GRAFT WERE IMPLANTED. DURING A RETROSPECTIVE STUDY OF 502 PATIENTS TREATED FOR THORACIC ENDOVASCULAR AORTIC REPAIR, THE FOLLOWING EVENTS WERE OBSERVED: PRE-OP DISSECTION, INTENTIONAL VESSEL COVERAGE, TYPE A DISSECTION, ISCHEMIA, PRE-OP TRANSECTION, RENAL FAILURE, PARAPLEGIA, SPINAL CORD ISCHEMIA, STROKE, ACUTE TYPE I ENDOLEAK, TYPE II, TYPE III SEPARATION, POSITIONING DIFFICULTIES, DEATH, RENAL FAILURE, POST-OP RUPTURE, PRE-OPRUPTURE. NO ADDITIONAL INFORMATION IS AVAILABLE. OBJECTIVE: THE INTRODUCTION OF AORTIC STENT GRAFTING IN THE TREATMENT OF THORACIC AORTIC DISEASE HAS PIONEERED UNIQUE TREATMENT OPTIONS AND GAINED RAPID CLINICAL ADOPTION DESPITE A PAUCITY OF LONG-TERM OUTCOME DATA. THE PURPOSE OF THIS ANALYSIS IS TO EXAMINE ALL OPERATIONS PERFORMED USING THORACIC AORTIC STENT GRAFTS AT THE UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM. METHODS: A TOTAL OF 502 OPERATIONS INVOLVING THORACIC AORTIC STENT GRAFTING WERE PERFORMED BETWEEN APRIL 1999 AND APRIL 2009. PATIENTS WERE FOLLOWED IN A PROSPECTIVELY COLLECTED CLINICAL PERIOPERATIVE REGISTRY, AND LONG-TERM OUTCOMES WERE DETERMINED FROM ADMINISTRATIVE DATA SOURCES. AORTIC PATHOLOGIES INCLUDED AORTIC ANEURYSM, ACUTE AORTIC DISSECTION (TYPES A AND B), HYBRID ARCH REPAIRS, REINTERVENTIONS WITH ADDITIONAL STENTS, PSEUDOANEURYSM, CHRONIC TYPE B DISSECTION, TRAUMATIC TRANSECTION, PENETRATING AORTIC ULCER, AND OTHER UNIQUE INDICATIONS. RESULTS: PATIENTS¿ MEAN AGE AT THE TIME OF THORACIC ENDOVASCULAR AORTIC REPAIR WAS 70.1_12.4 YEARS, AND 51%OF THE PATIENTS WERE AGED MORE THAN 70 YEARS. SOME 41% OF PATIENTS WERE FEMALE, AND THE MAJORITY OF PATIENTS (87%) WERE HYPERTENSIVE. OVERALL 30-DAY MORTALITY WAS 10.1%. MULTIVARIABLE RISK FACTORS FOR 30-DAY MORTALITY INCLUDED URGENT/EMERGENCY, STANFORD TYPE A AORTIC DISSECTION, PERIOPERATIVE SPINAL ISCHEMIA, TYPE C AORTIC COVERAGE, HYBRID ARCH OPERATION, AORTIC TRANSECTION, CHRONIC RENAL FAILURE, AND AGE. NEUROLOGIC COMPLICATIONS INCLUDED PERMANENT COMPLETE OR INCOMPLETE PARAPLEGIA IN 17 PATIENTS (3.4%), REVERSIBLE SPINAL CORD ISCHEMIA IN 26 PATIENTS (5.1%), TRANSIENT STROKE IN 16 PATIENTS (3.2%), AND PERMANENT STROKE IN 23 PATIENTS (4.6%). GREATER EXTENT OF AORTIC COVERAGEWAS NOT ASSOCIATED WITH RISK OF SPINAL CORD ISCHEMIA. ACCESS COMPLICATIONS, STROKE, AND ENDOLEAKS DIMINISHED WITH INCREASED OPERATIVE EXPERIENCE OVER TIME. RISK FACTORS FOR LATE MORTALITY INCLUDED URGENT/EMERGENCY INDICATIONS, HYBRID PROCEDURES, TRAUMATIC AORTIC TRANSECTION, AGE, PERIOPERATIVE PARALYSIS, AND CHRONIC RENAL FAILURE. PATIENTS UNDERGOING STENT GRAFTING FOR TYPE B DISSECTION WERE MORE LIKELY TO SURVIVE THAN PATIENTS UNDERGOING STENT GRAFTING FOR ANEURYSMS OR OTHER INDICATIONS. CONCLUSIONS: THORACIC AORTIC STENT GRAFTING HAS EVOLVED TO BE A VIABLE OPTION TO COMPLEMENT, AUGMENT, OR EVEN REPLACE TRADITIONAL TREATMENTS FOR AORTIC DISEASE. THESE DATA ILLUSTRATE THE APPLICABILITY OF THIS EVOLVING TECHNOLOGY IN THE ESTABLISHMENT OF NEW TREATMENT PARADIGMS FOR COMPLEX AORTIC PATHOLOGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309849 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Death