BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3625375 · Received February 12, 2014

    Report

    Report Number
    2953200-2014-00244
    Event Type
    Death
    Date Received
    February 12, 2014
    Date of Event
    May 18, 2012
    Report Date
    January 17, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: OCCLUSION, VASCULAR BYPASS/CONVERSION, RENAL FAILURE, INFECTION, CVA/STOKE, DEATH. UNKNOWN CAUSE OF EVENTS. USE OF THE DEVICE IN A PATIENT FOR TRAUMATIC AORTIC INJURY. CONCLUSION: UNKNOWN CAUSE OF EVENTS. USE OF THE DEVICE IN A PATIENT FOR TRAUMATIC AORTIC INJURY.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: AN OUTCOME ANALYSIS OF ENDOVASCULAR VERSUS OPEN REPAIR OF BLUNT TRAUMATIC AORTIC INJURIES ALI AZIZZADEH, MD, KRISTOFER M. CHARLTON-OUW, MD, ZHONGXUE CHEN, PHD, MOHAMMAD H. RAHBAR, PHD, ANTHONY L. ESTRERA, MD, HAMMAD AMER, MD, SHEILA M. COOGAN, MD, AND HAZIM J. SAFI, MD HTTP://DX.DOI.ORG/10.1016/J.JVS.2012.05.110 THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, STROKE, INFECTION, RENAL, OCCLUSION, VASCULAR BYPASS/CONVERSION. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. BACKGROUND: AORTIC INJURY IS THE SECOND MOST COMMON CAUSE OF DEATH AFTER BLUNT TRAUMA. THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) HAS BEEN RAPIDLY ADOPTED AS AN ALTERNATIVE TO THE TRADITIONAL OPEN REPAIR (OR) FOR TREATMENT OF TRAUMATIC AORTIC INJURY (TAI). THIS PARADIGM SHIFT HAS IMPROVED THE OUTCOMES IN THESE PATIENTS. THIS STUDY EVALUATED THE OUTCOMES OF TEVAR COMPARED WITH OR FOR PATIENTS WITH TAI. METHODS: WE ANALYZED PROSPECTIVELY COLLECTED DATA FROM THE INSTITUTIONAL TRAUMA REGISTRY BETWEEN APRIL 2002 AND JUNE 2010. THESE DATA WERE SUPPLEMENTED WITH A RETROSPECTIVE REVIEW OF HOSPITAL FINANCIAL ACCOUNTS. THE PRIMARY OUTCOME WAS THE PRESENCE OR ABSENCE OF ANY COMPLICATION, INCLUDING IN-HOSPITAL DEATH. SECONDARY OUTCOMES INCLUDED FIXED, VARIABLE, AND TOTAL HOSPITAL COSTS AND INTENSIVE CARE UNIT (ICU), PREOPERATIVE, POSTOPERATIVE AND TOTAL HOSPITAL LENGTH OF STAY (LOS). RESULTS: AMONGST 106 CONSECUTIVE PATIENTS (74 MEN; MEAN AGE, 36.4 YEARS), 56 UNDERWENT OR AND 50 UNDERWENT TEVAR FOR TREATMENT OF TAI. THE PROPORTION OF PATIENTS WHO UNDERWENT TEVAR COMPARED WITH OR INCREASED FROM 0% TO 100% DURING THE STUDY PERIOD. THE TEVAR PATIENTS WERE SIGNIFICANTLY OLDER THAN THE OR PATIENTS (41.1 VS 32.2 YEARS, P =.012). FOR PATIENTS WHO UNDERWENT TEVAR, THE ESTIMATED ODDS RATIO (95% CONFIDENCE INTERVAL) OF COMPLICATIONS, INCLUDING IN-HOSPITAL MORTALITY WAS 0.33 (0.11-0.97; P = .045) COMPARED WITH THE OR GROUP. THE AVERAGE NUMBER OF COMPLICATIONS, INCLUDING IN-HOSPITAL DEATH, WAS HIGHER IN THE OR GROUP THAN IN THE TEVAR GROUP (ADJUSTED MEANS, 1.29 VS 0.94). THE O.R. GROUP HAD A HIGHER PROPORTION OF PATIENTS WITH COMPLICATIONS, INCLUDING IN-HOSPITAL DEATH, COMPARED WITH THE TEVAR GROUP (69.6% VS 48%). ALTHOUGH, THE MEAN ADJUSTED VARIABLE COSTS WERE HIGHER FOR TEVAR THAN FOR OR (P = .017), THE MEAN ADJUSTED FIXED AND TOTAL COSTS WERE NOT SIGNIFICANTLY DIFFERENT. OWING TO A POLICY OF DELAYED SELECTIVE MANAGEMENT, THE ADJUSTED PREOPERATIVE LOS WAS SIGNIFICANTLY HIGHER FOR TEVAR (9.8 VS 3.0 DAYS, P = .022). THE DIFFERENCE IN THE ICU OR TOTAL HOSPITAL LOS WAS NOT SIGNIFICANT. ALTHOUGH THE PROPORTION OF UNINSURED PATIENTS WAS SIMILAR IN BOTH GROUPS, THE COHORT (N = 106) HAD A SIGNIFICANTLY HIGHER PROPORTION OF UNINSURED PATIENTS (29% VS 5%) COMPARED WITH THE GENERAL VASCULAR SURGICAL POPULATION AT OUR INSTITUTION (0.29 VS 0.051, 95% CONFIDENCE INTERVAL FOR DIFFERENCE IN PROPORTIONS, 0.22-0.40; P <(><<)> .0001). CONCLUSIONS: COMPARED WITH TEVAR, PATIENTS WHO UNDERWENT OR HAD THREE TIMES HIGHER ODDS TO FACE A COMPLICATION OR IN-HOSPITAL DEATH. THE MEAN TOTAL COST OF TEVAR WAS NOT SIGNIFICANTLY DIFFERENT THAN OR. THE FINDINGS SUPPORT THE USE OF TEVAR OVER OR FOR PATIENTS WITH TAI. ( J VASC SURG 2013;57:108-15.) THE EXACT DATE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92449 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Death| R