BEUDAMED
    FDA Adverse Event Injury Summary report: N

    360 EXPRESS BALLOON

    MDR report key: 5866668 · Received August 10, 2016

    Report

    Report Number
    3004904811-2016-00059
    Event Type
    Injury
    Date Received
    August 10, 2016
    Report Date
    July 15, 2016
    Manufacturer
    MEDTRONIC
    Product Code
    GEI
    PMA / PMN Number
    K142364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A LITERATURE ABSTRACT FOR A HUMAN CLINICAL STUDY WAS REVIEWED. THERE IS NOT CURRENTLY A FULL ARTICLE FOR THIS ABSTRACT. PUBLICATION TYPE IS A CONFERENCE. THIS INCIDENT IS SPECIFIC TO 1 SUPERFICIAL MUCOSAL LACERATION THAT DID NOT REQUIRE INTERVENTION. GASTROINTESTINAL ENDOSCOPY. CONFERENCE: DIGESTIVE DISEASE WEEK, DDW 2016 ASGE SAN DIEGO, CA UNITED STATES. CONFERENCE START: 20160521 CONFERENCE END: 20160524. CONFERENCE PUBLICATION: (VAR.PAGINGS). 83 (5 SUPPL. 1) (PP AB555), 2016. DATE OF PUBLICATION: MAY 2016. INTRODUCTION: RADIOFREQUENCY ABLATION (RFA) FOR BARRETT'S ESOPHAGUS (BE) GENERALLY STARTS WITH BALLOON-BASED CIRCUMFERENTIAL RFA (C-RFA), FOLLOWED EVERY 3 MONTHS BY ADDITIONAL ABLATION UNTIL THE ENTIRE BE IS ERADICATED. C-RFA REQUIRES SIZING OF THE ESOPHAGEAL INNER DIAMETER (EID) AT MULTIPLE LEVELS TO SELECT AN ABLATION CATHETER WITH AN APPROPRIATE DIAMETER. A RECENT STUDY DEMONSTRATED THAT STANDARD C-RFA RESULTS IN A BE SURFACE REGRESSION OF 83% AT 3-MONTH FOLLOW-UP, WITH A MEDIAN PROCEDURE TIME OF 39 MIN. BY INCORPORATING THE SIZING AND ABLATION BALLOON INTO A SINGLE DEVICE, PROCEDURE TIME MAY BE SHORTENED AND THIS CATHETER MAY ADJUST FOR DIFFERENCES IN EID OVER THE LENGTH OF THE ABLATION ZONE. AIMS & METHODS: AIM WAS TO ASSESS EFFICACY AND SAFETY OF THE RECENTLY DEVELOPED BARRXTM 360 EXPRESS RFA BALLOON CATHETER (360 EXPRESS). PATIENTS WITH BE 2-10CM WITH LOW-GRADE DYSPLASIA (LGD), HIGH-GRADE DYSPLASIA (HGD) OR EARLY CANCER (EC) WERE INCLUDED. VISIBLE LESIONS WERE REMOVED BY ENDOSCOPIC RESECTION (ER) PRIOR TO RFA. C-RFA WAS PERFORMED USING THE 360 EXPRESS (2X12J/CM<SUP>2</SUP> WITH CLEANING OF THE ABLATION ZONE AND CATHETER IN BETWEEN). ADDITIONAL TREATMENT WAS SCHEDULED EVERY 3 MONTHS, UNTIL COMPLETE CLEARANCE OF BE. PRIMARY OUTCOME: PERCENTAGE OF VISUAL BE SURFACE REGRESSION AT 3 MONTHS GRADED BY TWO ENDOSCOPISTS. SECONDARY OUTCOMES: C-RFA PROCEDURE TIME USING THE 360 EXPRESS AND COMPLICATIONS RELATED TO THE 360 EXPRESS PROCEDURE. RESULTS: THIRTY PATIENTS (24 M, MEDIAN 66 YRS, MEDIAN BE C4M6) WERE INCLUDED. EIGHT PATIENTS UNDERWENT ER PRIOR TO RFA (EC, N=5; HGD, N=2; LGD, N=1). WORST HISTOLOGY PRIOR TO RFA: HGD, N=6; LGD, N=22; NO DYSPLASIA, N=2. MEDIAN BE REGRESSION AT 3 MONTHS WAS 90% (IQR 77-95). MEDIAN PROCEDURE TIME WAS 31 MIN (IQR 28-38). BY NOVEMBER 2015, 15/30 PATIENTS ACHIEVED COMPLETE ERADICATION OF DYSPLASIA AND INTESTINAL METAPLASIA. ALL PATIENTS UNDERWENT 1 C-RFA SESSION AND A MEDIAN OF 2 ADDITIONAL ABLATION SESSIONS. IN 1 PATIENT ADDITIONAL ER WAS PERFORMED. IN 2 PATIENTS TREATMENT WAS STOPPED (PRIMARY LUNG CANCER, WITHDRAWAL OF CONSENT). THIRTEEN PATIENTS ARE STILL UNDER TREATMENT. COMPLICATIONS WITH THE 360 EXPRESS OCCURRED IN 3/30 PATIENTS (ATRIAL FIBRILLATION; ADMISSION FOR NAUSEA AND DYSPHAGIA WITHOUT STENOSIS UPON ENDOSCOPY; DYSREGULATED DIABETES). IN 7 PATIENTS ESOPHAGEAL SCARRING WAS OBSERVED DURING THE 3 MONTHS ENDOSCOPY, WITHOUT AN ENDOSCOPICALLY OR CLINICALLY RELEVANT STENOSIS. TWO OF THESE PATIENTS DEVELOPED DYSPHAGIA AFTER ADDITIONAL ABLATION, REQUIRING DILATION. CONCLUSION: THE 360 EXPRESS MAY SHORTEN C-RFA PROCEDURE TIME, WHILE MAINTAINING EFFICACY WHEN COMPARED TO STANDARD C-RFA. NO SEVERE ADVERSE EVENTS RELATED TO USE OF THE DEVICE WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517481 360 EXPRESS BALLOON ELECTROSURGICAL COAGULATION SYSTEM GEI MEDTRONIC 64082

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention