Evolution G51183Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002511832), received between Jun 26, 2020 and May 16, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2024Migration; Migration

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN ESOPHAGEAL STENT PLACEMENT PROCEDURE TO TREAT AN ESOPHAGEAL MASS IN WHICH THE EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT- FULLY COVERED, G51183, WAS USED. THE STENT BECAME DISPLACED. THE STENT HAD TO BE RETRIEVED FROM THE PATIENT'S MOUTH USING FORCEPS. PATIENT/EVENT INFO - NOTES: GENERAL QUESTIONS: AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? WHILE REMOVING THE INTRODUCER WHEN UNPACKING OR PREPARING THE EVOLUTION WHILE INSERTING THE EVOLUTION IN THE PATIENT DURING STENT PLACEMENT WHILE REMOVING THE INTRODUCER **** THIS ONE**** DURING STENT REPOSITIONING/REMOVAL WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? N/A WHAT WAS THE POSITION OF THE ELEVATOR? N/A WAS IT OPENED OR CLOSED? DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? SAVARY .035 GUIDEWIRE, 250CM DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? YES HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? 30 SECONDS FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION COMPLETE AND HOW OFTEN? STRICTURE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331429 ↗
• MalfunctionJun 26, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "THE STENT WOULD OPEN, BUT WOULD NOT DEPLOY. ANOTHER G51183-EVO-FC-18-23-12-E WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY." PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? - NO. IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? - NO. IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? - NO. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? - NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? - NO. · PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. PATIENT/EVENT INFO - NOTES: IS THE PATIENT CONFIRMED COVID-19 POSITIVE? - PER DM, NO. (B)(4). RF (B)(6) 2020. GENERAL QUESTIONS: 1.1.1 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? - THE DEPLOYMENT STATE AT THE END. WHEN UNPACKING OR PREPARING THE EVOLUTION. WHILE INSERTING THE EVOLUTION IN THE PATIENT. DURING STENT PLACEMENT (THIS OPTION). WHILE REMOVING THE INTRODUCER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10199318 ↗