BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 7111858 · Received December 13, 2017

    Report

    Report Number
    2953200-2017-01964
    Event Type
    Death
    Date Received
    December 13, 2017
    Date of Event
    October 10, 2008
    Report Date
    December 13, 2017
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE NECK ANGULATION AND LENGTH MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; DEVICE-SPECIFIC OUTCOMES FOLLOWING ENDOVASCULAR AORTIC ANEURYSM REPAIR L. WALES, M. DUNCKLEY, N. BOHM, T. KWOK, M. BRATBY, R. MORGAN, M. THOMPSON, I. LOFTUS (2008 EUROPEAN SOCIETY FOR VASCULAR SURGERY) 1078-5884/$34 ª 2008 EUROPEAN SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER LTD. ALL RIGHTS RESERVED. DOI:10.1016/J.EJVS.2008.08.014. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    TALENT STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF INFRA-RENAL ABDOMINAL ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED; REINTERVENTION, LIMB OCCLUSION, PROCEDURE RELATED DEATH, TYPE I ENDOLEAK, TYPE III ENDOLEAK, ANEURYSM RUPTURE, RETROPERITONEAL HAEMORRHAGE, MYOCARDIAL INFARCTION, PNEUMONIA, RENAL IMPAIRMENT, SEPSIS, PERIPHERAL ARTERIAL, WOUND DEBRIDEMENT/DRAINAGE, GASTRO-INTESTINAL HAEMORRHAGE, GASTRO-INTESTINAL BLEED, ISCHAEMIC BLEED, MULTI-ORGAN FAILURE, MALIGNANCY, MESENTERIC ISCHAEMIA, UNCLASSIFIED DEATH. ABSTRACT OBJECTIVE: TO COMPARE ANEURYSM MORPHOLOGY, INITIAL OUTCOMES AND MID-TERM RESULTS IN PATIENTS RECEIVING TALENT OR ZENITH GRAFTS FOR ELECTIVE ENDOVASCULAR ANEURYSM REPAIR(EVR). METHODS: OVER A 6-YEAR TIME PERIOD ENDING IN 2007, 286 PATIENTS UNDERWENT ELECTIVE EVR OF INFRA-RENAL ABDOMINAL AORTIC ANEURYSMS USING TALENT OR ZENITH DEVICES. PATIENT DEMOGRAPHICS, ANEURYSM MORPHOLOGY AND INITIAL OUTCOMES (PRIMARY-ASSISTED TECHNICAL SUCCESS RATES, 30-DAY LIMB OCCLUSION, RE-INTERVENTION AND MORTALITY) WERE COMPARED USING CHI-SQUARED TESTS OR STUDENT¿S T-TESTS. KAPLANEMEIER CURVES WERE CALCULATED TO COMPARE CUMULATIVE RATES OF FREEDOM FROM TYPE I OR III ENDOLEAK, RE-INTERVENTION, ENDOGRAFT PATENCY AND OVERALL SURVIVAL OVER MIDTERM FOLLOW-UP. RESULTS: ADVERSE ANEURYSM MORPHOLOGY WAS MORE COMMON IN PATIENTS RECEIVING ZENITH STENT GRAFTS, WITH A GREATER PROPORTION OF SHORTER NECK LENGTHS (<(><<)>10 MM, 12.9% VS 0%; P <(><<)> 0.001) AND SEVERE NECK ANGULATION (>60 DEGREES, 25.0% VS 10.3%; PZ0.002). EQUIVALENT PRIMARY-ASSISTED TECHNICAL SUCCESS RATES WERE ACHIEVED WITH BOTH TALENT AND ZENITH GRAFTS (94.0% VS 96.1%;PZ0.41). A SIGNIFICANT NUMBER OF ADJUNCTIVE PROCEDURES WERE REQUIRED IN BOTH GROUPS TO OBTAIN A PROXIMAL ENDOGRAFT SEAL, WITH RELATIVELY MORE PROCEDURES PERFORMED IN THE TALENT GROUP (28.6% VS 12.4%; PZ0.003). EARLY OUTCOMES WERE SIMILAR FOR 30-DAY RE-INTERVENTION (5.3% VS 3.9%; PZ0.91), 30-DAY LIMB OCCLUSION (1.5% VS 2.6%; PZ0.51), 30-DAY MORBIDITY (6.8% VS 11.8%; PZ0.15) AND 30-DAY MORTALITY (4.5% VS 3.9%; PZ0.80). THE CUMULATIVE INCIDENCE OF FREEDOM FROM RE-INTERVENTION WAS 88.3 +/- 2.9%, 86.1 +/- 3.3% AND 84.1 +/- 3.9% AT 1, 2 AND 3 YEARS RESPECTIVELY. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN TALENT AND ZENITH GROUPS FOR RE-INTERVENTION, TYPE I OR III ENDOLEAK OR LIMB OCCLUSION RATES OVER THE SAME TIME PERIOD. OVERALL PATIENT SURVIVAL WAS 88.4 +/- 2.85% AT 1 YEAR, 83.7 +/- 4.0% AT 2 YEARS AND 78.9 +/- 5.5% AT 3 YEARS. CONCLUSIONS: EQUIVALENT PRIMARY-ASSISTED TECHNICAL SUCCESS RATES CAN BE ACHIEVED USING EITHER TALENT OR ZENITH ENDOGRAFTS FOR ENDOVASCULAR ANEURYSM REPAIR, BUT OPERATING TEAMS SHOULD BE PREPARED TO PERFORM ADDITIONAL ADJUNCTIVE PROCEDURES TO OBTAIN A PRIMARY PROXIMAL SEAL WITH EITHER STENT. THE ZENITH ENDOGRAFT PERFORMED WELL IN THE CONTEXT OF LESS FAVOURABLE PRE-OPERATIVE ANEURYSM MORPHOLOGY. BOTH TALENT AND ZENITH ENDOGRAFTS APPEARED EQUALLY DURABLE IN THE MEDIUM TERM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894235 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death