BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3213250 · Received July 9, 2013

    Report

    Report Number
    2953200-2013-01283
    Event Type
    Death
    Date Received
    July 9, 2013
    Date of Event
    January 1, 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
    UK
    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, INFECTION, MI, PARALYSIS, RENAL FAILURE, RUPTURE, DISSECTION, ISCHEMIA, OCCLUSION); (UNKNOWN CAUSE OF EVENT); FAILURE TO FOLLOW INSTRUCTIONS (COVERING THE INNOMINATE AND COMMON CAROTID ARTERY, TREATING AN INFECTED ANEURYSM). CONCLUSION: (UNKNOWN CAUSE OF EVENT); KNOWN INHERENT RISK OF A PROCEDURE (ENDOLEAK, DEATH, CVA, INFECTION, MI, PARALYSIS, RENAL FAILURE, RUPTURE, DISSECTION, ISCHEMIA, OCCLUSION); OFF ¿LABEL, UNAPPROVED OR CONTRAINDICATED USE (COVERING THE INNOMINATE AND COMMON CAROTID ARTERY, TREATING AN INFECTED ANEURYSM).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: ENDOVASCULAR TREATMENT OF ACUTE AORTIC SYNDROME. RACHEL E. CLOUGH, MB, BS, BS, MRCS, KEVIN MANI, MD, PHD, FRCS; LONDON, UNITED KINGDOM; AND UPPSALA, SWEDEN (J VASC SURG 201 1;54:1580-7.) ON AN UNKNOWN DATE BETWEEN AUGUST 1997 AND SEPTEMBER 2009, AN UNKNOWN ANEURX STENT GRAFT, AN UNKNOWN TALENT STENT GRAFT AND AN UNKNOWN VALIANT STENT GRAFT WERE IMPLANTED. DURING A RETROSPECTIVE STUDY OF 110 PATIENTS TREATED FOR ACUTE THORACIC AORTIC PATHOLOGY, THE FOLLOWING EVENTS WERE OBSERVED: INTENTIONAL VESSEL COVERAGE, PRE-OP DISSECTION, PRE-OP RUPTURE, INFECTION, PRE-OP TRANSECTION, DISSECTION, PAIN, END ORGAN ISCHEMIA, UNKNOWN ENDOLEAK, STROKE, PARAPLEGIA, DEATH, BYPASS, ILIAC RUPTURE, POST-OP RUPTURE, MI, TYPE I ENDOLEAK, INFOLDING, CONVERSION TO OPEN REPAIR, FISTULA, RENAL DISEASE. NO ADDITIONAL INFORMATION IS AVAILABLE. BACKGROUND: THE TERM ACUTE AORTIC SYNDROME (AAS) ENCOMPASSES A RANGE OF CONDITIONS THAT HAVE A RISK OF IMMINENT AORTIC RUPTURE AND WHERE DELAYS IN TREATMENT RESULT IN INCREASED MORTALITY. ENDOVASCULAR TREATMENT OFFERS AN ATTRACTIVE ALTERNATIVE TO OPEN SURGERY BUT LITTLE IS KNOWN ABOUT THE DURABILITY OF THE REPAIR AND THE FACTORS THAT PREDICT MORTALITY. METHODS: PROSPECTIVE DATA WERE COLLECTED FOR A COHORT OF 110 CONSECUTIVE PATIENTS WITH ENDOVASCULAR TREATMENT FOR AAS. PATIENT ANDPROCEDURAL CHARACTERISTICS WERE RELATED TO SHORT- AND MIDTERM OUTCOME USING MULTIVARIATE LOGISTIC REGRESSION ANALYSIS. RESULTS: THERE WERE 75 MEN AND 35 WOMEN WITH A MEDIAN AGE OF 68 (RANGE 57-76) YEARS. THE PATHOLOGIES TREATED WERE ACUTE DISSECTION (35), SYMPTOMATIC ANEURYSM (32), INFECTED ANEURYSM (18), TRANSECTION (12), CHRONIC DISSECTION (9), PENETRATING ULCER (3), AND INTRAMURAL HEMATOMA (1). THIRTY-DAY MORTALITY WAS 12.7% AND THIS WAS ASSOCIATED WITH HYPOTENSION (ODDS RATIO [OR], 5.25), USE OF GENERAL ANESTHETIC (OR, 5.23), LONG PROCEDURE DURATION (OR, 2.03), AND INCREASING AGE (OR, 1.07). THE CAUSES OF DEATH WERE AORTIC RUPTURE (4), MYOCARDIALINFARCTION (4), STROKE (3), AND MULTISYSTEM ORGAN FAILURE (3). THE STROKE AND PARAPLEGIA RATES WERE 7.3% AND 6.4%, RESPECTIVELY. THE 1-YEAR SURVIVAL WAS 81% AND THE 5-YEAR SURVIVAL 63%. SECONDARY PROCEDURES WERE REQUIRED IN 13 (11.8%) PATIENTS. FACTORS ASSOCIATEDWITH DEATH AT 1 YEAR WERE PRESENCE OF AN AORTIC FISTULA (OR, 9.78), PERIOPERATIVE STROKE (OR, 5.87), AND USE OF GENERAL ANESTHETIC (OR, 3.76); AND AT 5 YEARS WERE AORTIC FISTULA (OR, 12.31) AND INCREASING AGE (OR, 1.06). CONCLUSIONS: ACUTE AORTIC SYNDROME CARRIES SIGNIFICANT EARLY AND LATE MORTALITY. EMERGENCY ENDOVASCULAR REPAIR OFFERS A MINIMALLY INVASIVE TREATMENT OPTION ASSOCIATED WITH ACCEPTABLE SHORT AND MIDTERM RESULTS. CONTINUED SURVEILLANCE IS IMPORTANT AS SECONDARY PROCEDURES AND AORTIC-RELATED DEATHS CONTINUE TO OCCUR THROUGHOUT THE FOLLOW-UP PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314389 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Death