BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4178940 · Received October 16, 2014

    Report

    Report Number
    2953200-2014-02102
    Event Type
    Injury
    Date Received
    October 16, 2014
    Date of Event
    March 19, 2012
    Report Date
    October 6, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. ROLE OF MULTIDETECTOR CT ANGIOGRAPHY AND CONTRAST-ENHANCED ULTRASOUND IN REDEFINING FOLLOW-UP PROTOCOLS AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. R. MOTTA, L. RUBALTELLI, R. VEZZARO, V. VIDA, P. MARCHESI, R. STRAMARE, A. ZANON, M. BATTISTEL, M. SOMMAVILLA, D. MIOTTO. RADIOL MED (2012) 117:1079¿1092 DOI 10.1007/S11547-012-0809-X ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A ABDOMINAL AORTIC ANEURYSM. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: OBESITY; METEORISM; HEAVY CALCIFICATION; TYPE 1 ENDOLEAKS; TYPE 2 ENDOLEAKS; TYPE 3 ENDOLEAKS; MIXED TYPE 1B -3 ENDOLEAKS; MIXED TYPE 2-3 ENDOLEAKS; TYPE 1 ENDOLEAK WITH AN ASSOCIATED TYPE 2 ENDOLEAK; TOTAL LIMB OCCLUSION SHORTLY AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR); WHICH WAS CAUSED BY DEFECTIVE GRAFT EXPANSION AND LIMB THROMBOTIC DEPOSITS; LIMB ISCHAEMIA; REST PAIN; CLAUDICATION; KINKING; INFOLDING OF GRAFT LIMB SKELETON WITH IN SITU OCCLUSIVE THROMBOSIS, WHICH WAS TREATED BY PERCUTANEOUS REVASCULARISATION WITH CATHETER-DIRECTED IN SITU THROMBOLYSIS AND SELF-EXPANDING STENTING; ENDOGRAFT PARTIAL THROMBOSIS; THIN THROMBOTIC FILM. ABSTRACT: PURPOSE. CONTRAST-ENHANCED ULTRASONOGRAPHY (CEUS) IS AN APPEALING ALTERNATIVE TO COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) FOR THE FOLLOW-UP OF PATIENTS WHO UNDERWENT ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR). WE SOUGHT TO EVALUATE THE ACCURACY OF CEUS COMPARED WITH A PARTICULARLY TAILORED PROTOCOL OF CTA PERFORMED WITH A 64-ROW MULTIDETECTOR CT. MATERIALS AND METHODS. THE STUDY PROSPECTIVELY ENROLLED 88 CONSECUTIVE PATIENTS FOR CEUS AND CTA IMAGING DURING FOLLOW-UP AFTER EVAR, YIELDING 142 PAIRED EXAMINATIONS. THE OUTCOME IS REPRESENTED BY THREE MAIN GOALS: IDENTIFICATION AND CHARACTERISATION OF ENDOLEAKS, EVALUATION OF GRAFT PATENCY AND MEASUREMENT OF ANEURYSM DIAMETER. TRIPLE-PHASE CTA WAS THE GOLD STANDARD. RESULTS. SENSITIVITY AND SPECIFICITY OF CEUS COMPARED WITH CTA IN ENDOLEAK AND GRAFT PATENCY EVALUATION WERE 91.89% AND 100% AND 72% AND 100%, RESPECTIVELY. A VERY HIGH CORRELATION BETWEEN CTA AND CEUS DIAMETER MEASUREMENTS WAS ESTABLISHED. CEUS DID NOT APPEAR SUPERIOR TO CTA IN ENDOLEAK DETECTION, PROBABLY BECAUSE A TAILORED CTA PROTOCOL WITH A DELAYED PHASE (180 S) ALLOWS DETECTION OF LOW-FLOW ENDOLEAKS. CONCLUSIONS. PATIENT MANAGEMENT WAS NOT DIFFERENT. "STAFOLLOWING" CEUS AND CTA RESULTS. CTA CANNOT YET BE COMPLETELY REPLACED, BUT SEVERAL LIMITATIONS (RADIATION EXPOSURE, CONTRAST AGENT) ENCOURAGE REDEFINING THE ROUTINE FOLLOW-UP IMAGING MODALITY. WE SUGGEST AN ALGORITHM OF SURVEILLANCE ALTERNATING CTA AND CEUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657435 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention