BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT STENT GRAFT

    MDR report key: 2493729 · Received March 16, 2012

    Report

    Report Number
    2953200-2012-00567
    Event Type
    Death
    Date Received
    March 16, 2012
    Report Date
    February 20, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT INFORMATION DOES NOT MATCH INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC. EXACT DATE OF DEATH IS UNKNOWN. (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, OCCLUSION, RENAL FAILURE, MI, DEATH, RUPTURE), (UNKNOWN CAUSE OF EVENT). EVALUATION CONCLUSION: (UNKNOWN CAUSE OF EVENT).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE, WHICH IS SUMMARIZED AS FOLLOWS: A COMPARATIVE STUDY OF THE BELL-BOTTOM TECHNIQUE VS HYPOGASTRIC EXCLUSION FOR THE TREATMENT OF ANEURYSMAL EXTENSION TO THE ILIAC BIFURCATION, PETER A. NAUGHTON, JOURNAL OF VASCULAR SURGERY 2011;10:121. AN ENDURANT AND TALENT STENT GRAFTS WERE IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT. ANEURYSM AND VESSEL MORPHOLOGY NOT REPORTED. ON AN UNKNOWN DATE BETWEEN (B)(6) 2004 AND (B)(6) 2009, AN UNKNOWN ENDURANT STENT GRAFT AND AN UNKNOWN TALENT STENT GRAFT WERE IMPLANTED. DURING A RETROSPECTIVE STUDY OF 185 PATIENTS TREATED FOR EVAR, 67 OF WHICH WERE MEDTRONIC, THE FOLLOWING ADVERSE EVENTS WERE NOTED: BUTTOCK CLAUDICATION (2.1%), LIMB OCCLUSION (1.1%), PELVIC ISCHEMIA (1.1%), HEMATOMA, WOUND PAIN, WOUND INFECTION, MYOCARDIAL INFARCTION (N=3), ACUTE RENAL FAILURE (N=2), NON-SPECIFIC BOWEL CONDITIONS (N=3), UTI (N=1), DEATH WITHIN 30 DAYS (N=2), AAA RUPTURE (N=2), TYPE 1 OR TYPE III ENDOLEAK (N=11). METHODS: PATIENTS WITH CIAA WHO UNDERWENT EVAR WERE IDENTIFIED IN TWO TEACHING HOSPITALS. BELL-BOTTOM TECHNIQUE (BBT; ILIAC LIMB >20 MM) OR INTERNAL ILIAC ARTERY EMBOLIZATION AND LIMB EXTENSION TO THE EXTERNAL ILIAC ARTERY (IIE _ EE) WERE USED. OUTCOME BETWEEN THESE TWO APPROACHES WAS COMPARED. RESULTS: WE IDENTIFIED 185 PATIENTS. INDICATION FOR EVAR INCLUDED ASYMPTOMATIC ABDOMINAL AORTIC ANEURYSM (AAA) IN 157, SYMPTOMATIC OR RUPTURED ANEURYSM IN 19, AND CIAA IN 9. MEAN AAA DIAMETER WAS 59 MM. AMONG 260 LARGE CIAAS THAT WERE TREATED, BBT WAS USED TO TREAT 166 CIAA LIMBS, AND 94 LIMBS UNDERWENT IIE _ EE. TOTAL REINTERVENTION RATES WERE 11% FOR BBT (N _ 19) AND 19.1% FOR IIE _ EE (N _ 18, P _ .149). RATES OF REINTERVENTION FOR TYPE IB OR III ENDOLEAK WERE 4% FOR BBT (N _ 7) AND 4% FOR IIE _ EE (N _ 4; P > .99). THE DIFFERENCE IN LIMB PATENCY RATES WAS NOT SIGNIFICANT. THE 30-DAY MORTALITY RATE WAS 1%. MEDIAN FOLLOW-UP WAS 22 MONTHS. COMPLICATIONS DID NOT DIFFER SIGNIFICANTLY BETWEEN THE TWO GROUPS; HOWEVER, THE COMBINED INCIDENCE OF PERIOPERATIVE COMPLICATIONS AND REINTERVENTIONS WAS HIGHER IN THE IIE _ EE GROUP (49% VS 22%, P _ .002).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R