BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2000406 · Received February 18, 2011

    Report

    Report Number
    2953200-2011-00462
    Event Type
    Death
    Date Received
    February 18, 2011
    Report Date
    January 24, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: RESULTS: (LOT NUMBER, IMPLANT AND EVENT DATES WERE NOT PROVIDED), (CVA, DEATH, OCCLUSION, PARALYSIS). CONCLUSION: (LOT NUMBER, IMPLANT AND EVENT DATES WERE NOT PROVIDED). "LATE OUTCOMES FOLLOWING OPEN AND ENDOVASCULAR REPAIR OF BLUNT AORTIC INJURY" JOURNAL ARTICLE J VASCULAR SURGERY 2010. NONE OF THE EVENTS IN THE ARTICLE MATCH EVENT INFORMATION ALREADY KNOWN TO MEDTRONIC. THE PHYSICIAN WAS CONTACTED AND REQUESTED TO PROVIDE SPECIFIC INFORMATION RELATED TO EACH EVENT RELATED TO ANEURX DEVICES, SUCH AS THE LOT NUMBER, IMPLANT DATE, AND EXPLANT DATE. THE PHYSICIAN REPLIED THAT THE INFORMATION MAY BE AVAILABLE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: "LATE OUTCOMES FOLLOWING OPEN AND ENDOVASCULAR REPAIR OF BLUNT AORTIC INJURY." JOURNAL ARTICLE J VASCULAR SURGERY 2010. THIS JOURNAL ARTICLE REPORTED THE FOLLOWING INFORMATION: PREVIOUS STUDIES HAVE FOCUSED ON EARLY OUTCOMES OF OPEN (DESCENDING THORACIC AORTIC REPAIR (DTAR) AND ENDOVASCULAR (THORACIC ENDOVASCULAR ANEURYSM REPAIR (TEVAR) REPAIR OF BLUNT AORTIC INJURY (BLUNT THORACIC AORTIC INJURY (BTAI). LATE RESULTS REMAINS ILL-DEFINED AND ARE THE FOCUS OF THIS STUDY. METHODS: ONE HUNDRED NINE PATIENTS (1992-2010) UNDERWENT REPAIR FOR BTAI. MEAN AGE WAS (B)(6) (73.4% MALE). DTAR WAS PERFORMED IN 90, WITH LEFT HEART BYPASS (85) OR HYPOTHERMIC ARREST (5). TEVAR WAS USED IN 19 OF 45 PATIENTS TREATED SINCE 2002. A STRATEGY OF SELECTIVE DELAYED REPAIR HAS BEEN USED SINCE 1997, WITH 54 OF 75 PATIENTS TREATED WITH DELAYED REPAIR IN THIS INTERVAL. THE PRIMARY OUTCOME WAS VITAL STATUS (100% FOLLOW-UP; MEAN, 103.9 MONTHS). RESULTS: MEAN INJURY SEVERITY SCORE WAS 39.5. THIRTY-DAY MORTALITY WAS 4.6% (N=5). EARLY MORBIDITY INCLUDED PERMANENT SPINAL CORD ISCHEMIA (SCI, 1.8%), STROKE (2.8%), AND NEED FOR PERMANENT DIALYSIS (1.8%). ENDOGRAFT COLLAPSE OCCURRED IN ONE PATIENT, NECESSITATING REINTERVENTION. FREEDOM FROM AORTIC REINTERVENTION AT 4 YEARS WAS HIGHER AFTER OPEN REPAIR (DTAR 100% VS TEVAR 94%, P = 0.03). CONCLUSIONS: WITH CAREFUL SELECTION, OPEN OR ENDOVASCULAR REPAIR OF BTAI HAS EXCELLENT EARLY AND LATE RESULTS. ALTHOUGH TEVAR HAS AN INCREASED RISK FOR REINTERVENTION, FACTORS OTHER THAN TREATMENT STRATEGY IMPACT LATE SURVIVAL. THESE DATA SUPPORT THE GROWING ROLE OF AN ENDOLUMINAL APPROACH FOR BTAI IN ANATOMICALLY APPROPRIATE PATIENTS. THE MEAN AGE OF THE ENTIRE COHORT WAS (B)(6) YEARS (73.4 MALE). DEMOGRAPHICS AND COMORBIDITIES FOR THE ENTIRE COHORT ARE LISTED IN THE TABLE. FOR THOSE PATIENTS UNDERGOING TEVAR, TECHNICAL SUCCESS WAS ACHIEVED IN ALL. DEVICES UTILIZED INCLUDED TAG (WL GORE, (B)(4); N=13) , TALENT (MEDTRONIC, (B)(4); N = 3), ANEURX (MEDTRONIC, N = 1), AND TX2 (COOK, (B)(4), N=2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death| R