Evolution G48038Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10827002480381), received between May 6, 2016 and May 12, 2026 — classified as 9 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (22 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Material Deformation; Material Twisted/Bent

  UPON NORMAL OPENING OF THE PACKAGE, THE STENT WAS INTRODUCED ALONG THE WIRE GUIDE. HOWEVER, UPON REACHING THE STENOSIS AREA, RESISTANCE WAS ENCOUNTERED JUST AS IT WAS ABOUT TO REACH THE TURNING POINT, MAKING IT DIFFICULT TO ADVANCE THE STENT DELIVERY SYSTEM. AFTER SEVERAL ATTEMPTS, IT WAS UNSUCCESSFUL. UPON RETRACTION OF THE STENT DELIVERY SYSTEM, TWO KINKS WERE OBSERVED ON THE STENT SHEATH. CONCERNED ABOUT POTENTIAL ACCIDENTS IF THE STENT WAS CONTINUED TO BE USED, A NEW STENT WAS SUBSTITUTED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ARE THERE ANY CLINICAL IMAGING/VIDEOS AVAILABLE? NO. WAS THE PRODUCT INSPECTED FOR DAMAGE BEFORE USE? (KINKS ETC) NO. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? 0.035'' WIRE GUIDE. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY? NO. WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? NO. WAS AN ASSESSMENT CARRIED OUT TO DETERMINE THE NECESSITY FOR PRE-DILATION? NO DILATION. WAS RESISTANCE ENCOUNTERED WHEN ADVANCI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152445 ↗
• MalfunctionApr 3, 2026Break; Activation Failure

  DURING EXPANSION, SOMETHING CRACKED IN THE HANDLE AND THE PROSTHESIS DID NOT OPEN. AFTER STARTING TO EXPAND THE STENT USING THE TRIGGER, A CRACKING SOUND WAS HEARD AND THE STENT STOPPED RESPONDING TO THE TRIGGER. IS THE COMPLAINT DEVICE AVAILABLE FOR RETURN TO CIRL? IF SO, PLEASE PROVIDE TRACKING NUMBER DETAILS. YES, DHL (B)(4). ARE THERE ANY IMAGES/VIDEOS OF THE COMPLAINT DEVICE/PROCEDURE AVAILABLE? NO. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? PENTAX 4.2 MM. WHAT WAS THE TARGET LOCATION? SIGMOID COLON. WHAT WAS THE DIAMETER OF THE WIRE GUIDE USED? COOK MEDICAL-METII-35-480. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? YES. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? NO. WAS PRE-DILATION/POST-DILATION PERFORMED? NO. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? (IF RESISTANCE WAS FELT HOW DID THE PHYSICIAN DEAL WITH THE RESISTANCE ENCOUNTERED?) NO RESISTANCE. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? (IF RESISTANCE WAS FELT HOW DID THE PHYSICIAN DEAL WITH THE RESISTANCE ENCOUNTERED?) NONE. WAS A STENT PREVIOUSLY PLACED AT THE SAME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779596 ↗
• MalfunctionNov 13, 2025Activation Failure; Activation Failure

  THE HANDLE/GUN SYSTEM WAS VERY HARD AND GOT JAMMED, HENCE THE STENT COULD NOT BE USED. ADDITIONAL INFORMATION RECEIVED ON 05NOV2025. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? NO. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? COLONOSCOPE TO BE USED NOT ENDOSCOPE, (MAKE ¿ OLYMPUS). WHAT WAS THE TARGET LOCATION? COLON. WHAT WAS THE DIAMETER OF THE WIRE GUIDE USED? 0.035 X 480 CM (METII-35-480). DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? NO. IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE (E.G., CHOLEDOCHOJEJUNOSTOMY) N/A. WAS PRE-DILATION/POST-DILATION PERFORMED? N/A. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? YES. WAS THERE RESISTANCE FELT PASSING WIRE GUIDE THROUGH STRICTURE? NO. WAS THERE RESISTANCE FELT PASSING THE EVOLUTION THROUGH STRICTURE? NO. WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? NO. IF ADDITIONAL INTERVENTION WAS PERFORMED, WAS IT DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? NO ADDITIONAL PROCEDURE WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23551204 ↗
• MalfunctionJun 6, 2025Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  AFTER STENT DEPLOYMENT, USER DETECTED THE PROXIMAL END OF STENT STILL INSIDE SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. 1. WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? NO ELEVATOR. 3. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? ALL STENT. 4. WHAT WAS THE TARGET LOCATION? RECTOSIGMOID JUNCTION. 5. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE (E.G., CHOLODOCHJEJUNOSTOMY) NO. 6. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? NO. 7. IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED. N/A. 8. WAS THE DIRECTIONAL BUTTON PRESSED DURING USE? NO. 9. WAS THE YELLOW MARKER KEPT IN VIEW DURING DEPLOYMENT? YES. 10. WAS FINAL STENT PLACEMENT CONFIRMED USING ENDOSCOPY/FLUOROSCOPY? (IF YES, WHAT WAS USED?) STENT WAS NOT DEPLOYED SUCCESSFULLY. 11. DID THE STENT OPEN S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157935 ↗
• MalfunctionJan 13, 2025Material Twisted/Bent; Material Twisted/Bent

  USER DETECTED THE STENT CANNOT BE DEPLOYED ANYMORE AFTER 50% OF STENT WAS ALREADY RELEASED. AND THE RETRACTION WIRE IS ALREADY PULLED OUT. USER PULLED THE DELIVERY SYSTEM AND STENT TOGETHER FROM PATIENT. USER CHANGED TO BOSTON SCIENTIFIC STENT TO COMPLETE THE PROCEDURE. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137553 ↗
• MalfunctionDec 11, 2024Dent in Material; Activation Failure; Dent in Material; Activation Failure

  THE COLONOSCOPE WAS INTUBATED THROUGH THE GUIDE WIRE CATHETER. AFTER THE GUIDE WIRE PASSED THROUGH THE STENOSIS, THE STENT WAS IMPLANTED ALONG THE GUIDE WIRE TO CROSS THE STENOSIS. THE STENT COULD NOT BE RELEASED AFTER 2 CENTIMETERS. THE GUN WAS FIRED FROM BEHIND. EVEN AFTER THE HANDLE IS BROKEN, IT CANNOT BE PUSHED AND PULLED TO RELEASE. AFTER REPLACING THE BRACKET, THE BRACKET CAN BE RELEASED NORMALLY. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE." 1. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? DURING STENT PLACEMENT EVOLUTION 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS 260 COLONOSCOPY WITH 3.7MM WORKING CHANNEL DIAMETER 260 3.7MM 3. WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? NONE ELEVATOR 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? METII-35-480 5. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? NO. 6. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901531 ↗
• MalfunctionDec 3, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IN THE INTERVENTIONAL DEPARTMENT, THE CATHETER WAS INSERTED THROUGH A WIREGUIDE CATHETER, AND THE STENT WAS ADVANCED ALONG THE WIRE GUIDE TO CROSS THE STENOSIS, AFTER THE STENOSIS WAS CROSSED, THE STENT CANNOT BE RELEASED ANYMORE AFTER 2 CM OF STENT ALREADY RELEASED, AND IT COULD NOT BE PUSHED OR PULLED TO RELEASE THE STENT AFTER THE HANDLE WAS DISASSEMBLED, AND USER CHANGED TO ANOTHER STENT WHICH CAN BE DEPLOYED NORMALLY. PATIENT OUTCOME: "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE." 1. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? (WHEN UNPACKING OR PREPARING THE EVOLUTION, WHILE INSERTING THE EVOLUTION IN THE PATIENT, DURING STENT PLACEMENT, WHILE REMOVING THE INTRODUCER, OR DURING STENT REPOSITIONING/REMOVAL) DURING STENT PLACEMENT EVOLUTION, EVOLUTION 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? UNDER DSA IN INTERVENTIONAL DEPARTMENT, PLACE STENT THROUGH WIRE GUIDE DSA 3. WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? N/A (NO ENDOSCOPE) 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832710 ↗
• MalfunctionMay 8, 2024Activation, Positioning or Separation Problem; Material Twisted/Bent; Activation, Positioning or Separation Problem; Material Twisted/Bent

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 20-DEC-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267852 ↗
• MalfunctionJan 30, 2024Material Twisted/Bent; Material Twisted/Bent

  USER DETECTED THE STENT CANNOT BE RELEASED. USER CANNOT CONFIRM IF THE ISSUE WAS CAUSED BY THE SHEATH OR STENT. USER HAS MANY YEARS EXPERIENCE USING THE DEVICE, AND IT MAY NOT RELATED TO USER'S TECHNIQUE. PATIENT OUTCOME: "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607365 ↗
• MalfunctionApr 21, 2023Activation, Positioning or Separation Problem; Material Twisted/Bent; Activation Failure; Activation, Positioning or Separation Problem; Material Twisted/Bent; Activation Failure

  SUPPLEMENT FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 29-MAY-2023 AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782761 ↗
• MalfunctionMay 25, 2022Break; Use of Device Problem; Break; Use of Device Problem

  COMPLAINT CALLED IN BY DM ON28APR2022--DID 28APR2022. AS REPORTED TO CUSTOMER RELATIONS: "THIS WAS USER ERROR. WHEN THEY WENT TO DEPLOY THE STENT, THE ASSISTANT PUSHED THE BUTTON TO RECAPTURE INSTEAD OF PUSHING IT TO DEPLOY. BY DOING THAT, PART OF THE CATHETER (BY THE HANDLE) SEPARATED. THEY NOTICED THE SEPARATION WHEN THEY REALIZED THEY NEEDED TO PUSH THE BUTTON IN THE OTHER DIRECTION AND THE DEVICE WOULDN'T DEPLOY. THEY WERE ABLE TO REMOVE THE COOK DEVICE WITHOUT ISSUE. THEY ENDED UP USING A COMPETITOR DEVICE (BOSTON DUODENAL STENT) IN THE COLON BECAUSE THEY DIDN'T HAVE ANOTHER COOK DEVICE HANDY. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? 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 THA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14495369 ↗
• MalfunctionApr 7, 2022No Display/Image; Improper or Incorrect Procedure or Method; Positioning Problem; No Display/Image; Improper or Incorrect Procedure or Method; Positioning Problem

  THE EXCREMENT KEEP COMING OUT WHILE PLACING STENT. THE YELLOW MARK CANNOT RECOGNIZE AT THE MOMENT WHICH CAUSED THE PROCEDURE FAILURE. LEAVE THE METAL STENT AT A WRONG POSITION IN PATIENT BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 14043149 ↗
• MalfunctionMar 29, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  USER ADVANCED THE DELIVERY SYSTEM TO STENOSIS, BUT FOUND OUT THE STENT SHAPE DEFORMED DURING DEPLOYMENT. SEE ATTACHED PIC. USER RETRACTED THE DEVICE FROM PATIENT, THEN CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. ((B)(4)). LAB EVALUATION DATE: 02 MAR 2022: VISUAL INSPECTION: LOCK WIRE NOT RETURNED. RED MARKER AT 4TH DIMPLING ON THE HANDLE. STENT WIRE APPEARS TO BE EXPOSED ON RETURN. FUNCTIONAL INSPECTION: HANDLE ACTUATED AS INTENDED. STENT DEPLOYED WITHOUT ISSUE BUT APPEARS TO BE VISUALLY DEFORMED. THIS FILE WILL CAPTURE USER ERROR, EVO-C IS NOT INTENDED TO BE REMOVED OR REPOSITIONED AFTER STENT PLACEMENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939063 ↗
• MalfunctionFeb 18, 2022Structural Problem; Material Twisted/Bent; Structural Problem; Material Twisted/Bent

  USER ADVANCED THE DELIVERY SYSTEM TO STENOSIS, BUT FOUND OUT THE STENT SHAPE DEFORMED DURING DEPLOYMENT. USER RETRACTED THE DEVICE FROM PATIENT, THEN CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE." 1. WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? METII-35-480 METII-35-480. 2. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? WITH ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH PATIENT) ALSO ASK: 3. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED DURING THE PROCEDURE? OLYMPUS CF-HQ290I. CF-HQ290I. 4. HAD DILATION OF THE STRICTURE BEEN PERFORMED PRIOR TO STENT PLACEMENT? YES. 5. WHAT WAS THE DIAMETER OF THE STRICTURE AT THE TIME OF STENT PLACEMENT (IN MM)? 5MM MM)¿5MM. 6. WHAT WAS THE LENGTH OF THE STRICTURE AT THE TIME OF STENT PLACEMENT (IN CM)? 5CM CM)¿5CM. 7. PLEASE DESCRIBE THE LOCATION IN THE BODY WHERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13558880 ↗
• InjuryDec 7, 2021Premature Activation; Material Deformation; Premature Activation; Material Deformation

  USER FELT THE TRIGGER IS TOO TIGHT TO PULL DURING STENT DEPLOYMENT, AND THE TRIGGER IS TO ITS LIMIT WHILE THE STENT STILL CANNOT BE RELEASED. USER CALLED SALES REP. ON HOW TO HANDLE SUCH SITUATION WHO SUGGESTED TO PULL THE STENT RETRIEVE BUTTON TO RETRIEVE THE STENT SO THAT TO REPOSITION THE RELEASE LOCATION. USER CANNOT PULL THE RETRIEVE BUTTON, AND THEN USER PULLED BOTH TRIGGER AND RETRIEVE BUTTON SEVERAL TIMES WHILE THE STENT SUDDENLY RELEASED UNEXPECTLY IN A WRONG POSITION. THEN PATIENT WAS BACK TO EMERGENCY ROOM AND A SURGICAL CONSULTATION WAS ORGANIZED DUE TO THE SITUATION. AN EMERGENCY OPERATION IS CONDUCTED.

  Patient problems: Insufficient Information

  MAUDE report 12951595 ↗
• InjuryOct 29, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12719794 ↗
• InjuryJun 15, 2021Break; Structural Problem; Break; Structural Problem

  THE INNER CATHETER SHOWS TO BE IN THE PATIENT AFTER 3 DAYS AFTER THE STENT WAS IMPLANTED. STENT PLACEMENT REQUIRED OF TWO RECAPTURES BEFORE THE FINAL STENT PLACEMENT (NO PROBLEMS); THEY PULLED OFF THE SECURITY WIRE GUIDE (NO PROBLEM). THE STENT WAS PERFECTLY PLACED AND IT BEGAN TO DRAIN ALL DEBRIS, NEVERTHELESS THEY ENDOSCOPICALLY SAW SOMETHING WEIRD BUT COULDN'T BE CLEARLY SEEN, TOO MUCH DEBRIS. NEXT MONDAY THEY MADE AN X-RAY AND THEY FOUND WHAT THEY SUPPOSEDLY SAW. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A SECOND COLONOSCOPY TO EXTRACT THE PIECE OF CATHETER BROKEN AND LEFT INSIDE THE COLON. PATIENT OUTCOME: A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A SECOND COLONOSCOPY TO EXTRACT THE PIECE OF CATHETER BROKEN AND LEFT INSIDE THE COLON. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11997503 ↗
• MalfunctionFeb 2, 2021Break; Material Deformation; Break; Material Deformation

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11266804 ↗
• MalfunctionDec 22, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING THE PROCEDURE THE STENT IS NOT WORKING PROPERLY, THE STENT FAILS TO DEPLOY. NO ADDITIONAL INFORMATION RECEIVED TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11054788 ↗
• MalfunctionOct 14, 2020Mechanical Problem; Activation, Positioning or Separation Problem; Mechanical Problem; Activation, Positioning or Separation Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10676261 ↗
• MalfunctionMay 1, 2020Break; Break

  USER ADVANCED THE DEVICE TO DESIRED POSITION AND THEN PRESSED THE RELEASE BUTTON TO DEPLOY THE STENT BUT FOUND THE STENT CANNOT BE RELEASED. USER ALSO DETECTED THE PROXIMAL END OF SHEATH BROKEN. USER RETRACTED THE DEVICE AND CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE." PATIENT OUTCOME: "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE." PATIENT/EVENT INFO - NOTES: WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? METII-35-480. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? WITH ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH PATIENT) ALSO ASK: WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED DURING THE PROCEDUR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10016904 ↗
• MalfunctionApr 23, 2020Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  DEVICE FAILED TO DEPLOY "AS PER COMPLAINT FORM": TIGHT PROXIMAL SIGMOID STRICTURE WIRE POSITION GOOD THE STENT WAS POSITIONED ACROSS THE STRICTURE ON DEPRESSING THE TRIGGER TO DEPLOY A SNAPPING SOUND WAS HEARD IN THE GUN AND STENT WOULD NOT DEPLOY SO IT WAS REMOVED AND ANOTHER WAS USED A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

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

  MAUDE report 9991212 ↗
• InjuryDec 12, 2019Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  COMPLAINT CALLED IN BY DM ON 15NOV2019--DID 15NOV2019. AS REPORTED TO CUSTOMER RELATIONS: "STENT WOULD NOT DEPLOY OFF THE CATHETER. UNKNOWN WHAT THE PROBLEM, DM AND CUSTOMER TRIED ALL TROUBLESHOOTING THEY COULD THINK OF AND WERE NOT SUCCESSFUL. (DM WAS NOT PRESENT, TROUBLESHOOTING TOOK PLACE OVER THE PHONE). PULLED IT OUT AND ABORTED. WILL BE REATTEMPTING TODAY WITH THE DM PRESENT." A COMPETITIVE DEVICE WAS UTILIZED THE NEXT DAY WITH X-RAY AND REPRESENTATIVE (MYSELF AND COMPETITOR) THERE TO SUPPORT THE STAFF AND PHYSICIAN. ADDITIONAL INFORMATION RECEIVED 10-DEC-2019: THE PATIENT RECEIVED A CAT SCAN THAT EVENING (OF THE INITIAL SURGERY) THAT SHOWED THAT THE STENT WAS ACTUALLY MISDEPLOYED PROXIMAL TO THE STRICTURE. THE STENT WAS ACTUALLY LEFT IN THE PATIENT AND THE PHYSICIAN DID NOT USE FLUOROSCOPY DURING INITIAL STENT PLACEMENT. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. DUE TO REQUIREMENT CT SCAN AND REQUIREMENT FOR ADDITIONAL PROCEDURE NEXT DAY TO PLACE COMPETITOR STENT.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 9456796 ↗
• MalfunctionNov 15, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS FILE WAS CREATED TO DEAL WITH FLEXOR KINK / BREAK. THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT AS LAB EVALUATION RECEIVED SHOWED NO EVIDENCE OF FLEXOR KINK / BREAK. DURING A STENT PLACEMENT IN THE COLON, THE EVOLUTION DELIVERY SYSTEM ¿SNAPPED¿ WHEN PUSHING THE TRIGGER TO MOVE THE STENT FORWARD AND THEY HAD TO REPLACE IT WITH ANOTHER EVOLUTION (SAME SIZE) TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT AND SUCCESSFUL PROCEDURE WITH THE SECOND EVOLUTION STENT USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9326584 ↗
• MalfunctionOct 14, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA VERBAL CONVERSATION: A PATIENT UNDERWENT A COLONOSCOPY IN WHICH QTY. 1 OF THE EVOLUTION COLONIC CONTROLLED-RELEASE STENT-UNCOVERED, G48038, WAS USED. THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE STENT BUT NOTED IT WAS HARD TO SQUEEZE THE TRIGGER AND THAT SOMETHING HAD POPPED. THE DEVICE WAS REMOVED AND NOTED THAT THE STENT HAD NEVER EXITED THE CATHETER. ANOTHER OF THE SAME DEVICE ONLY IN AN 8CM SIZE WAS USED TO CONTINUE THE PROCEDURE WITH ON FURTHER COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9186019 ↗