Evolution G48026Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10827002480268), received between Jan 3, 2017 and Sep 24, 2026 — classified as 1 death, 7 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (19 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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890293 ↗
• MalfunctionJul 16, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25836380 ↗
• MalfunctionMay 6, 2026Break; Fracture

  THE STENT TIP IS BROKEN INSIDE THE PATIENT'S BODY AND CANNOT BE RELEASED NORMALLY. AFTER RETRACTION, A BALLOON IS USED FOR DILATION. 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. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? STENT PLACEMENT. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? COLONOSCOPY. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? METII-35-480. 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. INTESTINE. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? STENT WAS REMOVED IMMEDIATELY. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO. DID THE PRODUCT FAIL DURING STENT DEPLOYMENT OR RECAPTURE? YES. WAS THE DIRECTIONAL BUTTON PRESSED DURING USE? YES. WAS ANY PART OF THE STENT OBSERVED IN CONTACT WITH THE PATIENT¿S ANATOMY AT THE TIME OF FAILURE? YES. WAS THE YELLOW MARKER KEPT IN VIEW DUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25098861 ↗
• MalfunctionDec 24, 2025Break; Break

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 11-FEB-26.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887603 ↗
• MalfunctionDec 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 11-FEB-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885797 ↗
• MalfunctionNov 24, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  DESCRIPTION OF EVENT DOCTOR WAS BUSY INSERTING A METAL STENT IN THE PYLORIC CANAL WHERE THE CANCER TUMOR WAS PRESENT. THE DEPLOYMENT HAPPENED SMOOTHLY AND THE INDICATION FOR GOOD STENT PLACEMENT WAS FOLLOWED. THE YELLOW MARKER WAS IN VISION AND PROPER PLACEMENT WAS TO BE CONFIRMED. BEFORE THE CORRECT PLACEMENT WAS THEN CONFIRMED IT SEEMED THAT THE METAL STENT HAD ALREADY DETACHED FROM THE DEPLOYMENT CATHETER. WE TRIED TO RECAPTURE THE METAL STENT TO ENSURE CORRECT PLACEMENT. IT HAD THEN ALREADY SEEMED THAT THE STENT HAD DEPLOYED SLIGHTLY ABOVE THE STRICTURE. THE STENT DETACHED JUST BEFORE THE POINT OF NO RETURN WAS REACHED. OUR NEXT STEPS WERE THEN TO USE A DILATION BALLOON AS THE METAL STENT WAS NOT COVERING THE WHOLE STRICTURE. SUCCESSFUL DILATATION WAS ACHIEVED AND THE PROCEDURE WAS STILL A SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629780 ↗
• MalfunctionOct 30, 2025Material Twisted/Bent; Material Twisted/Bent

  SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE COMPLETION OF THE INVESTIGATION ON 11 DEC 2025 AND RECEIPT OF ADDITIONAL INFORMATION ON 12 NOV 2025 AS THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT. FDA MDR REPORTING NOT REQUIRED: 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)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING. THE PROCEDURE WAS CARRIED OUT WITH BOTH RADIOLOGICAL AND ENDOSCOPIC MONITORING. GUIDE-WIRE 0.035 IN X 450 CM WAS PLACED PAST A MALIGNANT STRICTURE IN THE PARS HORIZONTAL DUODENI (STRICTURE LENGTH APPROX. 3-4 CM). EASY TO PASS STRICTUR WITH GUIDEWIRE BUT NOT POSSIBLE TO PASS WITH THE GASTROSCOPE. THE STENT COULD EASILY BE BROUGHT DOWN UNRELEASED PAST THE STRICTURE SO NO PRE-DILATION WAS NECESSARY. NO RESISTANCE WHATSOEVER TO BRING THE SYSTEM DOWN PAST THE STRICTURE. WHEN I STARTED TO RELE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423274 ↗
• MalfunctionApr 2, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  WHEN INSTALLING A COOK DUODENAL PROSTHESIS, IT DID NOT OPEN. THE DOCTOR AND NURSE THEREFORE REMOVED THE DEVICE FROM THE ENDOSCOPE AND SAW, ONLY AT THAT MOMENT ,THAT THE DEVICE WAS DAMAGED, POTENTIAL PREVENTING RELEASE OF THE STENT. INDEED, WE SEE THE CABLE. A NEW STENT WAS PLACED WITHOUT ISSUE (LOT C2124298 SAME REFERENCE).THIS INCIDENT CAUSED A LOSS OF TIME FOR THE SERVICE BUT DID NOT RESULT IN ANY IMPACT ON PATIENT CARE. "AS PER CC FORM": EMAIL FROM ANSM:5-MARCH-24 15H09. NFEI-2024-0565 WHEN INSTALLING A COOK DUODENAL PROSTHESIS, IT DID NOT OPEN. THE DOCTOR AND NURSE THEREFORE REMOVED THE DEVICE FROM THE ENDOSCOPE AND SAW, ONLY AT THAT MOMENT ,THAT THE DEVICE WAS DAMAGED, POTENTIAL PREVENTING RELEASE OF THE STENT. INDEED, WE SEE THE CABLE. A NEW STENT WAS PLACED WITHOUT ISSUE (LOT C2124298 SAME REFERENCE).THIS INCIDENT CAUSED A LOSS OF TIME FOR THE SERVICE BUT DID NOT RESULT IN ANY IMPACT ON PATIENT CARE. 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 DUODENAL STENT FROM COOK SAME LOT NUMBER ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020335 ↗
• MalfunctionMar 5, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  THE STENT FAILED TO DEPLOY AND HAD TO OPEN ANOTHER STENT FOR THE SAME PATIENT AND THE SECOND STENT WAS DEPLOYED SUCCESSFULLY WITH NO ISSUES. "AS PER CC FORM": THE STENT FAILED TO DEPLOY. 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: 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 DEPLOYMENT, TRIGGER WOULDN¿T SQUEEZE 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? THERAPEUTIC DUODENOSCOPE, OLYMPUS. 3. WHAT WAS THE POSITION OF THE ELEVATOR? N/A, OPEN, CLOSED. OPEN 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? BSC JAG WIRE 0.035" 5. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? N/A, YES, NO. NA 6. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835842 ↗
• MalfunctionDec 15, 2022Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  STENT FAILED TO DEPLOY. "AS ,PER CC FORM": EVERYTHING WENT WELL WITH STENT DELIVERY SYSTEM IN PERFECT POSITION. HOWEVER, THE STENT DID NOT MOVE WHEN THE NURSE ATTEMPTED TO DEPLOY IT. 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. 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS DOUBLE CHANNEL THERAPEUTIC SCOPE. 3. WHAT WAS THE POSITION OF THE ELEVATOR? OPEN. 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? MET11-35-480. 5. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? YES. 6. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? NO (ONLY THE DELIVERY SYSTEM). 7. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. DUODE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15993206 ↗
• MalfunctionJan 27, 2022Break; Break

  USER RELEASE THE STENT FROM DELIVERY SYSTEM WHILE FOUND OUT THE TIP OF STENT HAS OBVIOUS BROKEN. USER RETRACTED THE STENT FROM PATIENT. USER CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. DEVICE EVALUATED ON 09-DEC-2021; "BROKEN SHUTTLE CAP AND KINKED POLYIMIDE" "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 13365494 ↗
• MalfunctionNov 18, 2021Material Separation; Material Deformation; Material Separation; Material Deformation

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE DEVICE EVALUATED ON (B)(6) -2021; "BROKEN SHUTTLE CAP AND KINKED POLYIMIDE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834790 ↗
• MalfunctionOct 28, 2021Material Separation; Device Damaged Prior to Use; Material Separation; Device Damaged Prior to Use

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12710556 ↗
• InjurySep 3, 2021Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration

  IMAGE REVIEW RECEIVED 15-SEP-2021: DISTAL MIGRATION CONFIRMED.

  Patient problems: Dysphasia; Obstruction/Occlusion

  MAUDE report 12419719 ↗
• MalfunctionFeb 18, 2021Activation Failure; 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 11342021 ↗
• InjuryAug 17, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ACCORDING TO THE INITIAL REPORTER: CUSTOMER DEPLOYED STENT COMPLETELY, AND THEY DID PULL THE SAFETY WIRE AT THE END OF DEPLOYING IT COMPLETELY. THE TECH DID SAY THEY ONLY PULLED THE SAFETY WIRE OUT ~4 INCHES, SO POSSIBLY NOT COMPLETELY. REALIZED THAT THE STENT WASN'T FULLY EXPANDING AND IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM CATHETER. COULDN'T GET IT DISLODGED FROM THE DELIVERY SYSTEM. THEY PULLED IT BACK AND IT ENDED UP IN THE STOMACH, WHERE IT DISLODGED, SO THEY HAD TO GO BACK DOWN TO USE AN OVER TUBE TO GET IT OUT OF THE PATIENT. STENT OBSERVED SHREDDED ONCE OUT OF THE PATIENT, BUT THEY DON'T KNOW WHEN THAT HAPPENED. CUSTOMER USED ANOTHER OF THE SAME DEVICE TO COMPLETE PROCEDURE SUCCESSFULLY, LONGER PROCEDURE BUT NOT PROLONGED HOSPITALIZATION. FURTHER INFORMATION WAS PROVIDED: THE STENT WAS NOT FULLY DEPLOYED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10412766 ↗
• InjuryJul 29, 2020Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10340822 ↗
• MalfunctionApr 14, 2020Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  USER ADVANCED THE DEVICE TO DESIRED POSITION AND PRESS THE TRIGGER TO START RELEASING THE STENT, BUT THERE IS NO SIGN OF STENT UNDER ENDOSCOPY AFTER THE STENT DEPLOYMENT COMPLETED. USER RETRACTED THE DEVICE AND CHECKED WHILE FOUND OUT THE STENT IS STILL INSIDE THE SHEATH AND CANNOT RELEASE. USER 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 problems: No Known Impact Or Consequence To Patient

  MAUDE report 9957228 ↗
• MalfunctionJan 2, 2020Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  THE STRICTURE WAS IN DUODENUM D-2 REGION AND THE LENGTH WAS MEASURED AROUND 4 CM. THE STENT JUMP OFF WITHIN TWICE THE TRIGER PRESSED AFTER RELEASING THE STYLET WHICH RESULTS IN THE INACCURATE POSITION TO COVER THE STRICTURE. MANAGED TO COMPLETE THE PROCEDURE BY DEPLOYING OTHER COMPANY STENTS. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DEPLOYMENT ISSUE RESULTING IN STENT DEPLOYED IN INCORRECT LOCATION¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9537590 ↗
• MalfunctionDec 2, 2019Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Activation, Positioning or Separation Problem; Insufficient Device Problem Information

  STENT SET UP ON A GUIDE WIRE OF 0.025INCH. DURING DEPLOYMENT, THE TEAM HEARS A SNAP, AND THERE IS NO RESISTANCE FELT. AN X-RAY IS MADE BUT THE DEPLOYMENT OF THE STENT IS NOT VISIBLE, THE TEAM TRIED TO RETRIEVE THE STENT BUT WITHOUT SUCCESS. IT HAS BEEN REMOVED FROM THE ENDOSCOPE. THE TEAM USED AN OTHER DEVICE TO END UP THE PROCEDURE.

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

  MAUDE report 9395357 ↗
• MalfunctionDec 2, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  USER ADVANCED THE DELIVERY SYSTEM TO DESIRED POSITION AND PRESSED TRIGGER WHILE FOUND OUT THE STENT CANNOT BE RELEASED AT ALL. USER RETRACTED THE DELIVERY SYSTEM FROM PATIENT AND TRIED TO RELEASE THE STENT AGAIN WHICH TURNS OUT STENT CANNOT BE RELEASED. USER THEN PULLED THE SAFETY WIRE OUT AND TRIED TO RELEASE THE STENT ONCE MORE AND FAILED TO RELEASE THE STENT. 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 Known Impact Or Consequence To Patient

  MAUDE report 9394558 ↗
• MalfunctionSep 9, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS: "DURING DEPLOYMENT, ON THE SECOND TRIGGER SQUEEZE THEY HEARD A CLICK AND CONTINUED TO TRY TO DEPLOY. HOWEVER, WITH EACH TRIGGER SQUEEZE THEY WERE UNABLE TO DEPLOY (NO RESISTANCE, BUT NO ACTION). REMOVED STENT AND DELIVERY SYSTEM. NO HARM TO PATIENT. NOTHING LEFT BEHIND IN THE PATIENT. ANOTHER OF THE SAME GPN WAS USED TO COMPLETE THE PROCEDURE.

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

  MAUDE report 8974189 ↗
• MalfunctionAug 2, 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¿. THE CLIENT REPORTS THAT, DURING THE PROCEDURE, WHEN THE PROSTHESIS WAS PLACED IN THE DUODENUM, THE PROSTHESIS WAS ATTEMPTED TO BE FIRED, BUT IT WAS FOUND THAT THE PROSTHESIS DID NOT ADEQUATELY FIRE/OPEN.

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

  MAUDE report 8854378 ↗
• MalfunctionJan 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¿. AS REPORTED TO CUSTOMER RELATIONS, "WE REMOVED THE RED TAB AND BEGAN TO DEPLOY THE STENT IN STANDARD FASHION. WHILE DEPLOYING IT WAS NOTED, NO EVIDENCE OF SHEATH SLIDING BACK. DISTAL ASPECT OF STENT WAS NOT OPENING. WE ARRIVED AT THE POINT OF NOT RETURN AND HAD NO EVIDENCE OF DISTAL STENT OPENING. AT THIS POINT THEY CAREFULLY EXAMINED THE DEVICE AND NOTICED THE BLUE OVER SHEATH WAS COMPLETELY SHEERED WHERE IT ENTERS THE HUB. UNABLE TO DEPLOY THE STENT AND THE CASE WAS ABORTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8292544 ↗
• MalfunctionSep 25, 2018Fracture; Material Deformation; Fracture; Material Deformation

  AROUND (B)(6) 2018: THE STENT WAS PLACED IN THE CURVED SITE OF THE DUODENUM. ON (B)(6) 2018: WHEN OLYMPUS'S JF-260V ENDOSCOPE WAS INSERTED INTO THE PATIENT TO TREAT CHOLANGITIS, THE PHYSICIAN FOUND THAT THE STENT WIRES FORMING "CROWNS" OR NEAR THE "CROWN" AT THE STOMACH SIDE WAS APPEARED TO BE BROKEN AND THE STENT EDGE WAS DEFORMED. SINCE THE ENDOSCOPE COULD NOT BE ADVANCED THROUGH THE STENT DUE TO THE DEFORMATION OF THE STENT EDGE, THE PHYSICIAN HAD TO LEAVE THE CHOLANGITIS UNTREATED. THE DAMAGED STENT REMAINED INSIDE THE PATIENT WITH NO ADDITIONAL TREATMENT AS WELL. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. UPDATED WITH ADDITIONAL INFORMATION (29/AUG/2018, (B)(4)): IT WAS CONFIRMED THAT THE PATIENT HAD BEEN UNDERGOING CHEMOTHERAPY AFTER STENT PLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7906175 ↗