BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 16475071 · Received March 2, 2023

    Report

    Report Number
    2029214-2023-00391
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    June 28, 2020
    Report Date
    April 14, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEE FOR LITERATURE ARTICLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    AYSEGÜL IDIL SOYLU, FATIH UZUNKAYA, ÜMIT BELET, HÜSEYIN AKAN; JOURNAL OF EXPERIMENTAL AND CLINICAL MEDICINE; 2021: 38(S1): 56-60; TRANSARTERIAL EMBOLIZATION OF ACUTE GASTROINTESTINAL BLEEDING; DOI: 10.52142/OMUJECM.38.SI.GASTRO.8 MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE THAT PATIENTS POTENTIALLY TREATED WITH ECHELON 10 CATHETERS HAD COMPLICATIONS. THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFICACY AND OUTCOME OF TRANSARTERIAL EMBOLIZATION (TAE) IN ACUTE GASTROINTESTINAL BLEEDING (AGIB) PATIENTS. THE DATA OF 30 PATIENTS WHO UNDERWENT TAE WITH COMPLAINT OF AGIB BETWEEN JANUARY 2007- MAY 2020 WAS COLLECTED RETROSPECTIVELY. FIVE OF THEM WERE FEMALE AND THE MEAN AGE WAS 56.5 YEARS. THERE WAS NO HEMORRHAGIC LESION DETECTED BY DSA IN SEVEN PATIENTS. TWENTY-THREE LESIONS WERE DETECTED AND EMBOLIZED. PROCEDURE: FOLLOWING THE MONITORIZATION OF PATIENT, A 5F INTRODUCER SHEATH WAS PLACED INTO COMMON FEMORAL ARTERY. CELIAC TRUNK, SUPERIOR MESENTERIC ARTERY (SMA) AND INFERIOR MESENTERIC ARTERY (IMA) WERE CATHETERIZED BY 5F SIMMONS-2 OR COBRA CATHETER SELECTIVELY. A 3F RENEGADE MICROCATHETER OR ECHELON 10 MICROCATHETER WAS USED FOR EMBOLIZATION ACCORDING TO THE DETECTED LESION AND THE NATURE OF THE EMBOLIZING AGENT TO BE USED. LL EMBOLIZATION PROCEDURES WERE DONE UNDER FLUOROSCOPY IN ORDER TO PREVENT OFF- TARGET EMBOLIZATION. N-BUTYL-2-CYANOACRYLATE, POLYVINYL ALCOHOL (PVA) PARTICLES, MICROSPHERE AND DETACHABLE COILS WERE USED AS EMBOLIZING AGENTS. RESULTS: WHEN PATIENTS WERE EVALUATED ACCORDING TO THE ETIOLOGY OF BLEEDING; IT WAS DUE TO GASTRODUODENAL ULCER IN SEVEN PATIENTS, GASTRIC CARCINOMA IN EIGHT PATIENTS, IATROGENIC BLEEDING IN THREE PATIENTS, PANCREATIC CANCER IN TWO PATIENTS, SECONDARY TO OTHER TUMORS IN FIVE PATIENTS, DIVERTICULITIS IN THREE PATIENTS, PANCREATITIS IN ONE PATIENT AND AMYLOID-RELATED BLEEDING IN ONE PATIENT. IDENTIFIED 8 PSEUDOANEURYSM, 10 TUMOR VASCULARITY, FIVE CONTRAST EXTRAVASATION AND SEVEN VASOSPASMS. EIGHT GASTRODUODENAL ARTERY, FIVE LEFT GASTRIC ARTERY, SIX SMA BRANCHES, ONE SPLENIC ARTERY, ONE RIGHT GASTRIC ARTERY, ONE LEFT GASTROEPIPLOIC ARTERY AND ONE INFERIOR PANCREATICODUODENAL ARTERY WERE EMBOLIZED. EMBOLIZATION COULD NOT BE PERFORMED IN ONE PATIENT BECAUSE CATHETERIZATION COULD NOT BE ACHIEVED SECONDARY TO TORTUOSITY AND VASOSPASM ALTHOUGH ANGIOGRAPHY REVEALED A BLEEDING FOCUS IN THE RIGHT GASTRIC ARTERY. IN ONE PATIENT, FRONT-BACK DOOR TECHNIQUE WAS USED TO CUT THE RETROGRADE FLOW AND BOTH THE INFERIOR PANCREATICODUODENAL ARTERY AND THE LEFT GASTRIC ARTERY WERE EMBOLIZED. TAE TECHNICAL SUCCESS WAS 90.9% AND RECURRENT BLEEDING OCCURRED ONLY IN TWO PATIENTS. NONE OF THE PATIENTS EXPERIENCED INTESTINAL ISCHEMIA OR DUODENAL STENOSIS DURING THE POSTPROCEDURAL PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946431 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention