BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX - UNK

    MDR report key: 6796564 · Received August 16, 2017

    Report

    Report Number
    2953200-2017-01285
    Event Type
    Injury
    Date Received
    August 16, 2017
    Date of Event
    July 1, 2017
    Report Date
    July 21, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUED FROM BLOCK : OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE OF DEVICE OUTSIDE OF IFU INDICATION (IMPLANTING STENT GRAFT IN IVC) TITLE: ENDOVASCULAR ILIOCAVAL STENT RECONSTRUCTION FOR INFERIOR VENA CAVA FILTER¿ASSOCIATED ILIOCAVAL THROMBOSIS: APPROACH, TECHNICAL SUCCESS, SAFETY, AND TWO-YEAR OUTCOMES IN 120 PATIENTS AUTHORS: JEFFREY FORRIS BEECHAM CHICK, MD, MPH, DABR, ALEXANDRIA JO, MD, J. MATTHEW MEADOWS, MD, STEVEN D. ABRAMOWITZ, MD, MINHAJ S. KHAJA, MD, MBA, KYLE J. COOPER, MD, AND DAVID M. WILLIAMS, MD, FSIR J VASC INTERV RADIOL 2017; 28:933¿939 HTTP://DX.DOI.ORG/10.1016/J.JVIR.2017.04.017.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ENDOVASCULAR ILIOCAVAL STENT RECONSTRUCTION FOR INFERIOR VENA CAVA FILTER¿ASSOCIATED ILIOCAVAL THROMBOSIS: APPROACH, TECHNICAL SUCCESS, SAFETY, AND TWO-YEAR OUTCOMES IN 120 PATIENTS JEFFREY FORRIS BEECHAM CHICK, MD, MPH, DABR, ALEXANDRIA JO, MD, J. MATTHEW MEADOWS, MD, STEVEN D. ABRAMOWITZ, MD, MINHAJ S. KHAJA, MD, MBA, KYLE J. COOPER, MD, AND DAVID M. WILLIAMS, MD, FSIR J VASC INTERV RADIOL 2017; 28:933¿939 HTTP://DX.DOI.ORG/10.1016/J.JVIR.2017.04.017 THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: SELF-LIMITING ACCESS-SITE HEMATOMAS, BLOOD LOSS, LOWER EXTREMITY SWELLING, PAIN, PERSISTENT LEG ULCERS, SHORTNESS OF BREATH, AND PULMONARY EMBOLISM. ABSTRACT PURPOSE: TO REPORT TECHNICAL SUCCESS, OUTCOMES, AND PATENCY OF ILIOCAVAL STENT RECONSTRUCTION FOR INFERIOR VENA CAVA (IVC) FILTER¿BEARING ILIOCAVAL THROMBOSIS. MATERIALS AND METHODS: A TOTAL OF 120 PATIENTS WITH 123 IVC FILTERS AND SYMPTOMATIC ILIOCAVAL THROMBOSIS UNDERWENT STENT RECONSTRUCTION. MEAN PATIENT AGE WAS 55 YEARS (RANGE, 19-88 Y). FILTERS INCLUDED 70 (57%) RETRIEVABLE AND 53 (43%) PERMANENT FILTERS. SYMPTOMS INCLUDED LOWER EXTREMITY SWELLING OR PAIN (N = 93), ULCERS (N = 8), PHLEGMASIA (N = 7), BACK PAIN (N = 5), SHORTNESS OF BREATH (N = 4), WORSENING RENAL FUNCTION (N = 2), AND STENOSIS IDENTIFIED DURING TRANSLUMBAR CATHETER PLACEMENT (N = 1). CLINICAL SUCCESS WAS DEFINED AS DECREASE IN CLINICAL, ETIOLOGY, ANATOMY, AND PATHOPHYSIOLOGY (CEAP) SCORE OF AT LEAST 1; RESOLUTION OF PRESENTING SYMPTOMS; OR NORMALIZATION OF RENAL FUNCTION IN PATIENTS WITH JUXTARENAL OR SUPRARENAL THROMBOSIS ON PRESENTATION. TECHNICAL ASPECTS OF RECONSTRUCTION, TECHNICAL SUCCESS, COMPLICATIONS, 6-MONTH CLINICAL RESPONSE, AND 6-, 12-, AND 24-MONTH PRIMARY, PRIMARY-ASSISTED, AND SE CONDARY STENT PATENCY RATES WERE RECORDED. RESULTS: STENT RECONSTRUCTION WAS TECHNICALLY SUCCESSFUL IN ALL 120 PATIENTS, 63 OFWHOM (53%) UNDERWENT THROMBOLYSIS. THIRTY FILTERS (24%) WERE RETRIEVED, AND 93 (76%) WERE EXCLUDED WITH STENT PLACEMENT ACROSS THE INDWELLING FILTER. SIX MINOR AND 2 MAJOR COMPLICATIONS OCCURRED. CLINICAL SUCCESS WAS ACHIEVED IN 115 PATIENTS (96%) AT 6 MONTHS. SIX-, 12-, AND 24-MONTH PRIMARY ILIOCAVAL STENT PATENCY RATES WERE 96.4%, 94.8%, AND 87.2%, RESPECTIVELY. TWENTY-FOUR MONTH PRIMARY-ASSISTED AND SECONDARY PATENCY RATES WERE 90.3% AND 94.2%, RESPECTIVELY. CONCLUSIONS: ILIOCAVAL STENT RECONSTRUCTION IS AN EFFECTIVE TREATMENT FOR FILTER-ASSOCIATED THROMBOSIS WITH 100% TECHNICAL SUCCESS AND 96% CLINICAL SUCCESS AT 6 MONTHS. TECHNICAL AND CLINICAL OUTCOMES IN PATIENTS WHO UNDERWENT FILTER RETRIEVAL VERSUS FILTER EXCLUSION WERE SIMILAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576830 ANEURX - UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention