BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 5653377 · Received May 13, 2016

    Report

    Report Number
    2953200-2016-01016
    Event Type
    Injury
    Date Received
    May 13, 2016
    Date of Event
    August 19, 2002
    Report Date
    April 28, 2016
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATES OF THE EVENTS ARE UNKNOWN. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; TRANSRENAL VERSUS INFRARENAL ENDOGRAFT FIXATION: INFLUENCE ON TYPE I ENDOLEAKS. SHAMES M1, BETROS F, DENNIEN B, GRAY-WEALE A, LIPPEY E, THURSBY P, LUSBY R. ANN VASC SURG. 2002 SEP;16(5):556-61. EPUB 2002 AUG 19. ANEURX AND TALENT STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM. THE FOLLOWING INFORMATION IS REVIEWED IN THIS JOURNAL ARTICLE: TYPE I ENDOLEAK, MIGRATION, OCCLUSION, PULMONARY EMBOLISM, HEMATOMA, POST-OPERATIVE ANEURYSM RUPTURE, AND TYPE II ENDOLEAK. ABSTRACT THE PURPOSE OF THIS STUDY WAS TO COMPARE THE RATE OF PROXIMAL TYPE I ENDOLEAKS IN PATIENTS UNDERGOING ENDOLUMINAL REPAIR OF INFRARENAL ABDOMINAL AORTIC ANEURYSMS WITH ENDOGRAFTS HAVING EITHER TRANSRENAL OR INFRARENAL FIXATION. FROM SEPTEMBER 1998 TO MAY 2000, 42 PATIENTS RECEIVED ENDOLUMINAL AORTIC GRAFTS FOR THE TREATMENT OF INFRARENAL ABDOMINAL AORTIC ANEURYSMS. PATIENTS RECEIVED EITHER TRANSRENAL OR INFRARENAL DEVICES, BASED ON THE SURGEON'S PREFERENCE. ALL PATIENTS HAD INFRARENAL AORTIC NECK LENGTHS MEASURING AT LEAST 1.5 CM AND PROXIMAL NECK ANGULATION OF <(><<)>60 DEGREES. THE ENDOLUMINAL GRAFTS WERE OVERSIZED BY 10-20% RELATIVE TO THE DIAMETER OF THE INFRARENAL AORTA. THE PRESENCE OF ENDOLEAKS WAS DETERMINED AT THE INITIAL PROCEDURE BY CONTRAST ANGIOGRAPHY AND DURING SUBSEQUENT FOLLOW-UP AT 1 MONTH AND 3 MONTHS BY CT SCAN OR DUPLEX ULTRASOUND. NO SIGNIFICANT DIFFERENCES IN THE RATE OF PROXIMAL TYPE I ENDOLEAKS CAN BE DEMONSTRATED BETWEEN TRANSRENAL AND INFRARENAL DEVICE TYPES IN THIS SMALL COHORT. PROPER PATIENT SELECTION IS MORE IMPORTANT THAN TYPE OF PROXIMAL FIXATION IN PREVENTING ENDOLEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309261 ANEURX STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention