BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT AAA

    MDR report key: 3408605 · Received October 14, 2013

    Report

    Report Number
    2953200-2013-01993
    Event Type
    Death
    Date Received
    October 14, 2013
    Date of Event
    March 6, 2013
    Report Date
    September 16, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, ENDOTENSION, RUPTURE, FISTULAE, REMOVAL OF IMPLANT, MYOCARDIAL INFARCTION (MI), PNEUMONIA, ACUTE RENAL FAILURE, BLEEDING COMPLICATIONS, HEMATOMA/ SEROMA, STROKE/PARESIS, SPINAL CORD INJURY, MULTISYSTEM ORGAN FAILURE (MSOF), DEATH AND AMPUTATIONS). (UNKNOWN CAUSE OF EVENTS, EVENTS IN THE LITERATURE REVIEW ARE KNOWN TO BE CONSISTENT WITH THE DEVICE PERFORMANCE). EVALUATION CONCLUSION: (UNKNOWN CAUSE OF EVENTS, EVENTS IN THE LITERATURE REVIEW ARE KNOWN TO BE CONSISTENT WITH THE DEVICE PERFORMANCE).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED OUTCOMES AFTER LATE EXPLANTATION OF AORTIC ENDOGRAFTS DEPEND ON INDICATION FOR EXPLANTATION. SHIPRA ARYA, DAWN M. COLEMAN, JORDAN KNEPPER, PETER K. HENKE, GILBERT R. UPCHURCH,3 JOHN E. RECTENWALD, ENRIQUE CRIADO, JONATHAN L. ELIASON, AND KATHERINE A. GALLAGHER. ANN VASC SURG 2013 27: 865¿873 THE FOLLOWING EVENTS WERE OBSERVED: PROXIMAL AND DISTAL TYPE I ENDOLEAK, TYPE II ENDOLEAK, TYPE III ENDOLEAK (UNKNOWN TYPE), ENDOTENSION, RUPTURE, INFECTION, FISTULAE, REMOVAL OF IMPLANT. POSTOPERATIVE VARIABLES ANALYZED INCLUDED SURGICAL SITE INFECTIONS (SUPERFICIAL/ DEEP), MYOCARDIAL INFARCTION (MI), PNEUMONIA, URINARY TRACT INFECTIONS, ACUTE RENAL FAILURE (PER RIFLE CRITERIA), VENTILATOR DEPENDENCE, NEED FOR TRACHEOSTOMY, BLEEDING COMPLICATIONS, HEMATOMA/ SEROMA, NEED FOR RE-EXPLORATION, DISSEMINATED INTRAVASCULAR COAGULOPATHY (DIC), STROKE/PARESIS, SPINAL CORD INJURY, MULTISYSTEM ORGAN FAILURE (MSOF), AND AMPUTATIONS. IN ADDITION, INTENSIVE CARE UNIT (ICU) LENGTH OF STAY, OVERALL HOSPITAL LENGTH OF STAY (LOS), MORTALITY, AND DISCHARGE TO A SKILLED NURSING FACILITY WERE RECORDED. MAJOR MORBIDITY WAS DEFINED AS ANY POSTOPERATIVE COMPLICATIONS RESULTING IN PROLONGED LENGTH OF STAY, DIC, MSOF, NEED FOR REEXPLORATION, DIALYSIS-DEPENDENT RENAL FAILURE, VENTILATOR DEPENDENCE, MI REQUIRING REVASCULARIZATION, LIMB LOSS, STROKE, OR SPINAL CORD INJURY. BACKGROUND: WITH THE GROWING PREVALENCE OF ENDOVASCULAR REPAIR FOR ABDOMINAL AORTIC ANEURYSM (AAA), THE NUMBER OF PATIENTS REQUIRING GRAFT EXPLANTATION IS INCREASING. THEREFORE, KNOWLEDGE RELATED TO OUTCOMES AFTER EXPLANTATION MAY LEAD TO IMPROVEMENT IN SURGICAL OPTIONS. IN THIS STUDY WE COMPARE OUR EXPERIENCE WITH EXPLANTATION OF AORTIC ENDOGRAFTS, BASED ON INDICATION. METHODS: THE MEDICAL RECORDS OF ALL AORTIC PROCEDURES PERFORMED AT OUR CENTER WERE QUERIED DURING THE PERIOD FROM 2002 TO 2012. RELEVANT DATA FROM PATIENTS NEEDING EXPLANTATION OF AORTIC ENDOGRAFTS WERE ANALYZED USING FISHER¿S EXACT TEST, T-TEST, AND KAPLAN-MEIER ANALYSIS. RESULTS: THIRTY-NINE PATIENTS UNDERWENT AORTIC ENDOGRAFT EXPLANTATION (64.1% MEN). MEAN AGE WAS 71.9 YEARS WITH A MEAN ANEURYSM SIZE OF 6.8 CM (RANGE 3.5E10.7 CM). HYPERTENSION (97.4%), HYPERLIPIDEMIA (76.9%), AND HISTORY OF SMOKING (82%) WERE THE MOST PREVALENT RISK FACTORS. MEAN TIME TO EXPLANT WAS 41.7 MONTHS (RANGE 2.2E118.4 MONTHS). THE PRIMARY EXPLANT INDICATION WAS ENDOLEAK IN 27 (69.2%) AND INFECTION IN 12 (30.8%) PATIENTS. THE ENDOLEAK GROUP CONSISTED OF 13 TYPE I, 8 TYPE II, 1 TYPE III, 4 ENDOTENSION, 1 RUPTURE, AND 4 PATIENTS WITH MULTIPLE ENDOLEAKS. SEVEN PATIENTS WERE SYMPTOMATIC, WHEREAS 2 HAD RUPTURED ANEURYSMS. HALF OF THE PATIENTS IN THE INFECTION GROUP REQUIRED SUPRACELIAC CLAMPING FOR EXPLANTATION. OPERATIVE BLOOD LOSS (P ¼ 0.08) AND NEED FOR TRANSFUSION (P ¼ 0.005) WERE SIGNIFICANTLY HIGHER IN THE INFECTION GROUP. THIRTY-DAY MORBIDITY WAS 51.8% FOR THE ENDOLEAK GROUP AND 83% FOR THE INFECTION GROUP (P ¼ 0.08). THERE WERE ONLY 2 DEATHS IN THE COHORT WITHIN 30 DAYS, BOTH IN THE INFECTION GROUP. TWENTY-SEVEN PATIENTS WERE ALIVE AT A MEAN FOLLOW-UP OF 1.9 YEARS (RANGE 0.1E8.4 YEARS). CONCLUSIONS: ENDOGRAFT EXPLANTATION IS A CHALLENGING OPERATION WITH HIGH MORBIDITY AND MORTALITY. FURTHERMORE, PATIENTS WITH AN INFECTIOUS ETIOLOGY HAVE SIGNIFICANTLY WORSE OUTCOMES THAN THOSE REQUIRING EXPLANTATION FOR ENDOLEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525513 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Death