BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 8486141 · Received April 5, 2019

    Report

    Report Number
    2953200-2019-00449
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    October 4, 2018
    Report Date
    April 5, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AUTHORS: JOSEPH L. MCDEVITT RAVI N. SRINIVASA JOSEPH J. GEMMETE ANTHONY N. HAGE JOURNAL DETAILS: CARDIOVASC INTERVENT RADIOL 2019, 42:205¿212 DOI: HTTPS://DOI.ORG/10.1007/S00270-018-2090-1. 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 A JOURNAL ARTICLE ENTITLED; APPROACH, TECHNICAL SUCCESS, COMPLICATIONS, AND STENT PATENCY OF SHARP RECANALIZATION FOR THE TREATMENT OF CHRONIC VENOUS OCCLUSIVE DISEASE: EXPERIENCE IN 123 PATIENTS   OUT OF A PATIENT GROUP OF 123, ONE PATIENT RECEIVED AN ENDURANT STENT GRAFT SYSTEM AND ONE PATIENT RECEIVED AN ANEURX STENT GRAFT SYSTEM, FOR THE ENDOVASCULAR TREATMENT OF CHRONIC VENOUS OCCLUSIONS.   THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: OCCLUSION (LOSS OF STENT GRAFT PATENCY) NOTED ON FOLLOW-UP IMAGING. ABSTRACT PURPOSE: TO REPORT THE TECHNICAL SUCCESS AND COMPLICATIONS FOLLOWING SHARP RECANALIZATION OF CHRONIC VENOUS OCCLUSIONS. MATERIALS AND METHODS: A TOTAL OF 123 PATIENTS, INCLUDING 75 (61.0%) MEN AND 48 (39.0%) WOMEN, WITH MEAN AGE OF 50.5 ± 17.5 YEARS (RANGE 19¿90 YEARS), UNDERWENT SHARP RECANALIZATION OF CHRONIC VENOUS OCCLUSIONS. THE ETIOLOGIES OF OCCLUSION WERE CHRONIC DEEP VENOUS THROMBOSIS (N = 43;35.0%), PRIOR CENTRAL VENOUS ACCESS (N = 39; 31.7%), INDWELLING CARDIAC LEADS (N = 21; 17.1%), AND OCCLUDED VENOUS STENTS (N = 20; 16.3%). THE SITES OF VENOUS OCCLUSION INCLUDED 59/123 (48.0%) THORACIC CENTRAL VEINS, 37 (30.1%) NON-THORACIC CENTRAL VEINS, AND 27 (22.0%) PERIPHERAL VEINS. MEDIAN LENGTH OF OCCLUSION WAS 3.2 ± 1.4 CM (RANGE 1.3¿10.9 CM). RESULTS: SHARP RECANALIZATION WAS MOST COMMONLY ATTEMPTED WITH TRANSSEPTAL NEEDLES IN 108/123 (87.8%), WITH A MEAN NUMBER OF 1.2 ± 0.4 CROSSING DEVICES PER PATIENT (RANGE 1¿4 DEVICES). TARGETING DEVICES INCLUDED A LOOP SNARE (N = 92; 74.8%), PARTIALLY DEPLOYED WALLSTENT (N = 21; 17.1%), PARTIALLY DEPLOYED AMPLATZER VASCULAR PLUG (N = 8; 6.5%), AND AN ANGIOPLASTY BALLOON (N = 3;2.4%). TECHNICAL SUCCESS WAS ACHIEVED IN 111 (90.2%) PATIENTS. THERE WERE 3 (2.4%) SEVERE, 1 (0.8%) MODERATE, AND 7 (5.7%) MINOR ADVERSE EVENTS. SEVERE ADVERSE EVENTS INCLUDED 1 CASE EACH OF PERICARDIAL TAMPONADE, HEMOTHORAX, AND INFERIOR VENA CAVA FILTER OCCLUSION. 88 (71.5%) PATIENTS HAD VENOUS STENTS PLACED; AT THE LAST FOLLOW-UP EXAMINATION, 68/86 (79.0%) STENTS WERE PATENT. CONCLUSION: SHARP RECANALIZATION HAS A HIGH TECHNICAL SUCCESS AND LOW RATE OF ADVERSE EVENTS IN THE RECANALIZATION OF CHRONIC VENOUS OCCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281517 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other