Evolution G48028Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10827002480282), received between Nov 15, 2016 and Jun 10, 2026 — classified as 3 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (16 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 10, 2026Activation Failure

  THE STENT DELIVERY SYSTEM PASSED THROUGH THE ENDOSCOPIC WORKING CHANNEL AND REACHED THE LOCATION OF THE OBSTRUCTION IN THE SIGMOID COLON. USER ADVANCED SYSTEM THE STENOSIS AND RELEASED THE STENT. HOWEVER, IT WAS FOUND THAT THE STENT COULD NOT BE RELEASED. THE SAFETY WIRE WAS REMOVED, BUT THE STENT STILL COULD NOT BE RELEASED. SUBSEQUENTLY, IT WAS WITHDRAWN FROM THE BODY AND REPLACED WITH A NEW ONE TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462114 ↗
• MalfunctionAug 26, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING THE RELEASE PROCESS , THEN THE SHEATH WAS BENT, REPLACED WITH A NEW PRODUCT AND COMPLETED 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. ADDITIONAL INFORMATION RECEIVED ON 25AUG2025 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? DURING STENT PLACEMENT. WHEN UNPACKING OR PREPARING THE EVOLUTION, WHILE INSERTING THE EVOLUTION IN THE PATIENT, DURING STENT PLACEMENT, WHILE REMOVING THE INTRODUCE, DURING STENT REPOSITIONING/REMOVAL. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS COLONOSCOPY DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? YELLOW ZEBRA WIRE GUIDE DID ANY PART OF THE STENT CONTACT THE PATIENT'S ANATOMY WHEN THE COMPLAINT OCCURRED? YES WHAT WAS THE TARGET LOCATION? INTESTINAL OBSTRUCTION. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)?IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE (E.G., CHOLODOCHJEJUNOSTOMY) N/A WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894112 ↗
• MalfunctionJul 19, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  USER PULLED THE TRIGGER DURING STENT DEPLOYMENT, BUT FOUND OUT THE STENT CANNOT BE DEPLOYED. USER CHANGED TO A NEW DEVICE WHICH IS SUCCESSFULLY DEPLOYED. "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? NO INFORMATION PROVIDED 3. WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? CLOSE 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? METII-35-480 COOK,METII-35-480 5. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? NO INFORMATION PROVIDED 6. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? YES 7. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. COLON 8. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? NO. 9. FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785938 ↗
• MalfunctionApr 29, 2024Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  CLARIFICATION RECEIVED ON (B)(6)2024. THE STENT WAS DEPLOYED PREMATURELY BEFORE SAFETY WIRE BEING PULLED AND IT WAS REMOVED TOGETHER WITH THE DELIVERY SYSTEM. A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 19 SEP 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200588 ↗
• MalfunctionDec 15, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PROSTHESIS MADE A STRANGE NOISE AND IT DIDN'T RELEASE. "AS PER CC FORM": WHEN THEY STARTED TO RELEASE THE STENT, IT MADE A STRONG NOISE AND IT DIDN'T RELEASE THIS COMPLAINT WILL CAPTURE 01X CASE OF USE ERROR FOR NOT INSPECTING THE DEVICE PRIOR TO USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ANOTHER STENT 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 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS 3,7 CHANNEL 3. WHAT WAS THE POSITION OF THE ELEVATOR? . OPEN 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? VISIGLIDE GUIDEWIRE 5. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? N/A, YES, NO 6. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? YES 7. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. COLON 8. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? I DON'T KNOW 9. FOR DEVICES WHERE THE IFU STATES FOR LO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333987 ↗
• MalfunctionOct 10, 2023Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 21-NOV-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905288 ↗
• MalfunctionApr 3, 2023Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  THE PROSTHESIS MADE A STRANGE NOISE AND IT DIDN'T RELEASE. "AS PER CC FORM": WHEN THEY STARTED TO RELEASE THE STENT, IT MADE A STRONG NOISE AND IT DIDN'T RELEASE. PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ANOTHER STENT ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. PATIENT/EVENT INFO - NOTES: AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? DURING STENT PLACEMENT. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS 3,7 CHANNEL. WHAT WAS THE POSITION OF THE ELEVATOR? OPEN. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? VISIGLIDE GUIDEWIRE. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? N/A, YES, NO. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? YES. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. COLON. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? I DON'T KNOW. FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663049 ↗
• MalfunctionMar 8, 2023Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO INCLUDE THE LAB RE-EVALUATION AND THE COMPLETION OF THE INVESTIGATION ON THE 07-JUL-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501611 ↗
• MalfunctionAug 31, 2021Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391334 ↗
• InjuryDec 15, 2020Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  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 11009960 ↗
• MalfunctionNov 25, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  EVENT WAS PREVIOUSLY REPORTED BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR KINKED/STRETCHED/BROKEN/COMPRESSED¿. DEVICE EVALUATED ON (B)(6) 2020 " SHUTTLE CAP BROKEN". EVENT NO LONGER MEETS THE REQUIREMENTS OF A MALFUNCTION REPORT BASED ON THE LOW RISK ASSIGNED TO A SHUTTLE CAP BREAK. THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. USER ADVANCED THE DEVICE ABOUT 30CM AND SAW THE SPACE-OCCUPYING LESION WHICH BLOCK THE LUMEN. USER CHANGED ENDOSCOPY TO CONTINUE THE PROCEDURE BUT STILL CANNOT ADVANCE THE DEVICE. USER THEN TRIED USING ANGIOGRAPHY CATHETER WITH WIRE GUIDE TO PASS THROUGH THE BLOCK AREA BUT FAILED. USER CANNOT RELEASE THE STENT BY PULLING TRIGGER. 1. WAS THE DIRECTIONAL BUTTON FULLY ENGAGED? YES. 2. DID THE RED INDICATOR MOVE WHEN THE TRIGGER WAS PRESSED? NO. 3. DID THE RED INDICATOR CONTINUE TO MOVE AFTER THE DELIVERY STOPPED? STENT WAS NOT RELEASED. 4. WERE ANY CRACKING/POPPING SOUNDS HEARD FROM THE HANDLE? NO. 5. WAS THE STENT PARTIALLY EXPOSED? NO. 6. IF THE STENT WAS PARTIALLY EXPOSED, WAS IT POSSIBLE TO RECAPTURE THE STENT FULLY BEFORE REMOVAL? STENT WAS NOT PARTIALLY EXPOSED. 7. WERE ANY ADDITIONAL PRO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10905919 ↗
• InjuryNov 17, 2020Difficult to Remove; Structural Problem; Difficult to Remove; Structural Problem

  NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS RECEIVED.

  Patient problems: Perforation of Vessels

  MAUDE report 10853347 ↗
• MalfunctionJun 15, 2020Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  DURING PLACEMENT OF THE STENT, DURING DEPLOYMENT, THE TECH BEGAN TO TRIGGER SQUEEZE AND SQUEEZED IT 3 TIMES SMOOTHLY. UPON THE 4TH TRIGGER SQUEEZE, THE HANDLE BROKE AND WHEN IT BROKE, THE HANDLE CRACKED AND THE CABLE BROKE AT THE SHEATH AND THE HANDLE. THE STENT WAS BEGINNING TO EXIT THE INTRODUCER AT THIS TIME. THE DEVICE AND STENT WERE WITHDRAWN FROM THE SCOPE AND ANOTHER OF THE SAME DEVICE BUT DIFFERENT SIZE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ISSUES. THERE WAS NO HARM TO THE PATIENT AND NO INTERVENTIONAL PROCEDURES NEEDED. PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. PATIENT/EVENT INFO - NOTES: 1.1.1 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? DURING STENT PLACEMENT 1.1.2 WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS 3.7. 1.1.3 WHAT WAS THE POSITION OF THE ELEVATOR? NA. 1

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

  MAUDE report 10155075 ↗
• MalfunctionApr 30, 2020Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10013286 ↗
• MalfunctionNov 27, 2019Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  THEY INTRODUCED THE CATHETER IN THE SCOPE(OLYMPUS 160), AFTER ACROSS THE STENOSIS THEY TRIED TO OPEN THE STENT BUT WAS NOT POSSIBLE OPEN IT THIS IS A CANCELLATION REPORT BEING SENT WITH THE BELOW JUSTIFICATION: LAB EVALUATION COMPLETED ON 05-DEC-2019 AND DETERMINED THAT THE SHUTTLE CAP WAS FOUND TO BE BROKEN AND THEREFORE REMOVES THE FLEXOR PRECEDENCE REPORTED UNDER PREVIOUSLY. THE FILE HAS BEEN RE-ASSESSED AND HAS AN OVERALL RISK CATEGORY IIA (LOW). NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. LOW RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. FDA MDR REPORTING NOT REQUIRED: NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. THIS EVENT HAS BEEN RE-ASSESSED AND THIS REPORT IS TO NOTIFY THE FDA THAT THIS EVENT NO LONGER MEETS THE FDA REPORTING CRITERIA OF A MALFUNCTION REPORT AS PER SECTION 803.50 OF 21 CFR 803. NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING. COMPLAINTS OF THIS NATURE WILL CONTINU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9383113 ↗
• MalfunctionOct 10, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. FROM THE INITIAL INFORMATION RECEIVED, THIS EVENT WAS CAUTIOUSLY MADE REPORTABLE BASED ON THE PRECEDENCE IN PLACE FOR THIS DEVICE OF 'FLEXOR KINKED/STRETCHED/BROKEN/COMPRESSED'. HOWEVER, WHEN THE RETURNED DEVICE WAS RECEIVED IT WAS CONFIRMED DURING THE LAB EVALUATION THAT THIS MALFUNCTION DID NOT OCCUR. OVERALL RISK ASSOCIATED WITH THE FAILURE OBSERVED IN THE LABORATORY EVALUATION, SHUTTLE CAP BREAK, OVERALL RISK IS ASSESSED AS LOW. LOW RISK INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. COMPLAINT CALLED IN BY DM ON 13SEP2019--DID 13SEP2019. AS REPORTED TO CUSTOMER RELATIONS: "THE STENT WOULD NOT DEPLOY. THE CUSTOMER ACTIVATED THE TRIGGER BUT IT DIDN'T DEPLOY. CUSTOMER USED ANOTHER OF THE SAME GPN TO COMPLETE THE PROCEDURE." ADDITIONAL INFORMATION PROVIDED BY DM ON 04OCT2019: "THE RED BUTTON WAS ENGAGED FOR DEPLOYMENT BUT THE STENT WOULD NOT DEPLOY. THERE WAS NO CRACKING OR NOISE. THEY DONT REMEMBER IF THE RED INDICATOR MOVED OR NOT. THE STENT WAS NOT DEPLOYED BUT IT SEEMS TO HAVE BEEN RECAPTURED SOMEHOW A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9176912 ↗
• MalfunctionMay 31, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR KINKED/ STRETCHED/ BROKEN/ COMPRESSED'. USER ADVANCED THE DELIVERY SYSTEM ALONG WITH WIRE GUIDE TO DESIRED POSITION AND FOUND OUT THE STENT CANNOT BE RELEASED. THE STENT CANNOT BE RELEASED AFTER USER PULLED OFF THE SAFETY WIRE. USER CHANGED THE ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8657385 ↗
• MalfunctionApr 4, 2019Break; Break

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿TIP SEPARATION'. USER FOUND OUT THE WHITE COMPONENT FELL OFF FROM TOP OF SHEATH WHILE ADVANCING 10CM OF WIRE GUIDE. USER CHANGED ANOTHER SAME DEVICE TO FINISH THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8482015 ↗
• MalfunctionFeb 27, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  FLEXOR KINKED OBSERVED DURING LAB EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8373358 ↗
• MalfunctionJan 16, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR KINKED/ STRETCHED/ BROKEN/ COMPRESSED' "IMPOSSIBLE TO DEPLOY STENT" REP WILL ARRANGE RETURN. "AS PER COMPLAINT FORM": STENT WOULD NOT DEPLOY. ADDITIONAL INFORMATION RECEIVED (B)(6): 1. WAS THE DIRECTIONAL BUTTON FULLY ENGAGED? YES 2. DID THE RED INDICATOR MOVE WHEN THE TRIGGER WAS PRESSED?YES 3. DID THE RED INDICATOR CONTINUE TO MOVE AFTER THE DELIVERY STOPPED?YES 4. WERE ANY CRACKING/POPPING SOUNDS HEARD FROM THE HANDLE?NOT KNOWN 5. WAS THE STENT PARTIALLY EXPOSED?NO 6. IF THE STENT WAS PARTIALLY EXPOSED, WAS IT POSSIBLE TO RECAPTURE THE STENT FULLY BEFORE REMOVAL?NA 6. WERE ANY ADDITIONAL PROCEDURES NEEDED?NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8252017 ↗
• MalfunctionOct 31, 2018Break; Break

  THE DEVICE WAS EVALUATED ON THE 03-OCT-18 CONFIRMING THE "OUTER FLEXOR WAS BROKEN AT SHUTTLE CAP." THIS FIE IS BEING REPORTED ON THE FDA MDR REPORTABLE REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR KINKED/ STRETCHED/ BROKE/ COMPRESSED¿. AS REPORTED TO CUSTOMER RELATIONS: "AFTER TRAVERSING STRICTURE WITH WIRE GUIDE STENT WAS PLACED OVER WIREGUIDE AND PLACED DOWN SCOPE, AFTER STENT WAS EXITING SCOPE IT FELT DIFFICULT TO PUSH, THE SENT WAS THEN IN POSITION BUT UNDER FLUROSCOPIC IMAGE THE TIP OF STENT APPEARED TO BE APPROX 5CM AWAY FROM END OF STENT, NURSE BEGAN SQUEEZING TRIGGER TO BEGIN TO DEPLOY, WITH GREAT DIFFICULTY - THEN SHE FELT AND WE HEARD A SNAP- UNABLE TO RECAPTURE OR DEPLOY - STENT WAS REMOVED FROM SCOPE AND IT DID NOT DEPLOY - WE USED ANOTHER EVOLUTION COLONIC STENT OF SAME SIZE TO COMPLETE PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8024920 ↗
• MalfunctionJul 25, 2018Break; Break

  REPORT IS BEING SUBMITTED UNDER THE PRECEDENCE OF "FLEXOR KINKED/STRETCHED/BROKEN/COMPRESSED" AND "STENT REMOVED WHILE PARTIALLY EXPOSED". UPON REACHING THE POINT OF NO RETURN WHILE DEPLOYING THE STENT, DR (B)(6) SAID THAT THERE WAS SNAP AUDIBLE SOUND FROM THE DEVICE, IN FEAR OF THE STENT MAY CAUSE FURTHER COMPLICATION, DR (B)(6) ASKED THE NURSE TO RECAPTURE THE WHOLE STENT INTO THE DEVICE. AND "ACCORDING TO" HIM, THERE WAS NO ANY DIFFICULTY IN TAKING OUT THE DEVICE OUT FROM THE PATIENT. THE CASE WAS THEN COMPLETED BY USING A TAE-WOONG STENT AND CASE WAS REPORTED TO BE SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7718350 ↗
• MalfunctionMay 31, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING THE RELEASE THE GUN DIDN'T WORK PROPERLY THE STENT WAS ONLY PARTIALLY RELEASED AND A DIFFERENT ONE HAD TO BE IMPLANTED. "AS PER COMPLAINT FORM": THE STENT WAS NOT DELIVERED BECAUSE OF BROKERING OF THE RELEASE SYSTEM AND A SECOND STENTING WAS PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7557191 ↗
• MalfunctionApr 12, 2018Kinked; Kinked

  THE DEVICE WAS ADVANCED TO DESIRED POSITION AND THEN OPERATOR TRIGGERED THE STENT BUT FAILED. OPERATOR PULL THE DEVICE OUT A BIT AND FOUND OUT THE DISTAL END OF OUTER SHEATH IS BROKEN. REPORTING DUE TO PRECEDENCE: ISSUE OF ¿FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED" FOR THIS DEVICE FAMILY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7425467 ↗
• MalfunctionMar 22, 2018Delivery System Failure; Delivery System Failure

  MALFUNCTION OF THE HANDLE, PROSTHESIS COULDN'T BE RELEASED. "AS PER COMPLAINT FORM": THE MOMENT TO OPERATE THE HANDLE TO RELEASE THE STENT THIS MADE NOISE, THE STENT WAS NOT RELEASED, REMAINED INSIDE THE CATHETER. THEY CHECKED THE RELEASE BUTTON AND IT WAS CORRECT. THEY PROCEEDED TO REMOVE THE SYSTEM AND USE A NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7361496 ↗