BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT OCCLUDER

    MDR report key: 5217205 · Received November 11, 2015

    Report

    Report Number
    2953200-2015-01968
    Event Type
    Injury
    Date Received
    November 11, 2015
    Date of Event
    December 5, 2014
    Report Date
    October 19, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS IN THE PRESENCE OF A TRANSPLANTED KIDNEY DANIEL SILVERBERG ¿ TAL YALON ¿ MOSHE HALAK (CARDIOVASC INTERVENT RADIOL (2015) 38:833¿839) DOI 10.1007/S00270-014-1027-6. A TALENT OCCLUDER STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. IT WAS REPORTED ONE PATIENT SUFFERED A RUPTURED LEFT EXTERNAL ILIAC ARTERY DURING DELIVERY OF AN OCCLUDER DEVICE. AFTER PERFORMING THE AAA REPAIR WITH AN AORTOUNIILIAC DEVICE THROUGH THE RIGHT ILIAC ARTERIES, WE ATTEMPTED TO PLACE A 12-FRENCH SHEATH INTO THE LEFT EXTERNAL ILIAC ARTERY IN ORDER TO POSITION A TALENT OCCLUDER DEVICE IN THE LEFT COMMON ILIAC ARTERY. THE EXTERNAL ILIAC WAS SEVERELY DISEASED, AND RUPTURE OF THE ARTERY OCCURRED DURING THE INSERTION OF THE SHEATH. TEMPORARY CONTROL WAS OBTAINED WITH AN OCCLUSION BALLOON, FOLLOWED BY LIGATION OF THE RUPTURED ARTERY THROUGH A RETROPERITONEAL INCISION. WE THEN PERFORMED A PLANNED CROSSOVER FEMORAL BYPASS. THE TRANSPLANTED KIDNEY WAS PRESERVED IN ALL CASES, BASED ON COMPLETION ANGIOGRAM PERFORMED AT THE END OF THE CASE. PURPOSE TO PRESENT OUR EXPERIENCE PERFORMING ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS IN KIDNEY TRANSPLANTED PATIENTS. METHODS A RETROSPECTIVE REVIEW OF ALL PATIENTS WHO UNDERWENT ENDOVASCULAR ANEURYSM REPAIR (EVAR) FOR ABDOMINAL AORTIC ANEURYSMS (AAA) PERFORMED AT OUR INSTITUTION FROM 2007 TO 2014. WE IDENTIFIED ALL PATIENTS WHO HAD PREVIOUSLY UNDERGONE A KIDNEY TRANSPLANT. DATA COLLECTED INCLUDED: COMORBIDITIES, PREOPERATIVE IMAGING MODALITIES, INDICATION FOR SURGERY, STENT GRAFT CONFIGURATIONS, PRE- AND POSTOPERATIVE RENAL FUNCTION, PERIOPERATIVE COMPLICATIONS, AND SURVIVAL RATES. RESULTS A TOTAL OF 267 EVARS WERE PERFORMED. SIX (2 %) HAD A TRANSPLANTED KIDNEY. MEAN AGE WAS 74 (RANGE, 64¿82) YEARS; FIVE WERE MA LES. MEAN TIME FROM TRANSPLANTATION TO EVAR WAS 7.5 (RANGE, 2¿12) YEARS. FIVE UNDERWENT PREOPERATIVE PLANNING WITH NONCONTRAST MODALITIES ONLY. DEVICES USED INCLUDED BIFURCATED (N = 3), AORTOUNIILIAC (N = 2), AND TUBE (N = 1) STENT GRAFTS. TECHNICAL SUCCESS WAS ACHIEVED IN ALL PATIENTS. NONE EXPERIENCED DETERIORATION IN RENAL FUNCTION. MEDIAN FOLLOW-UP WAS 39 (RANGE, 6¿51) MONTHS. FOUR PATIENTS WERE ALIVE AT THE TIME OF THE STUDY. TWO PATIENTS EXPIRED DURING THE PERIOD OF FOLLOW-UP FROM UNRELATED CAUSES. CONCLUSIONS EVAR IS AN EFFECTIVE MODALITY FOR THE MANAGEMENT OF AAAS IN THE COEXISTENCE OF A TRANSPLANTED KIDNEY. IT CAN BE PERFORMED WITH MINIMAL MORBIDITY AND MORTALITY WITHOUT HARMING THE TRANSPLANTED KIDNEY. SPECIAL CONSIDERATION SHOULD BE GIVEN TO DEVICE CONFIGURATION TO MINIMIZE DAMAGE TO THE RENAL GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746924 TALENT OCCLUDER SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention