Evolution G23130Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10827002231303), received between Jul 12, 2017 and Apr 23, 2026 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Physical Resistance/Sticking

  LAST WEEK THE TEAM USED AN UNCOVERED STENT. THE STENT WAS DEPLOYED (NOT FULLY) BUT WASN'T IN THE CORRECT POSITION SO NEEDED TO BE ALTERED, HOWEVER WHEN THE TEAM ATTEMPTED TO RE-SHEATH IT, IT UNFORTUNATELY WOULD NOT RETRACT FULLY. THE STENT HAD NOT BEEN DEPLOYED BEYOND THE POINT OF NO RETURN AT ANY STAGE. AS THE STENT COULD NOT BE FULLY RE SHEATHED, IT HAD TO BE COMPLETELY REMOVED, AND A DIFFERENT STENT WAS USED INSTEAD. I¿VE ATTACHED A PHOTO SHOWING THE END OF THE STENT FOR REFERENCE. WHAT WAS THE TARGET LOCATION? RIGHT HEPATIC DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? ACROBAT WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? NO WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? WIRE PASSED WITHOUT DIFFICULTY IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE (E.G., CHOLODOCHOJEJUNOSTOMY) NO; STANDARD ANATOMY WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? PERIHILAR 2CM WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? NO WAS AN ASSESSMENT CARRIED OUT TO DETERMINE THE NECESSITY OF PRE-DILATION? ALMOST NEVER PREDILATE WAS THE SAFETY WIRE REMOVED? IF YES, AT WHAT POIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965765 ↗
• MalfunctionJan 19, 2026Deformation Due to Compressive Stress; Activation Failure

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 04-MAR-2026. ADDITIONAL QUESTIONS ANSWERED ON 08-JAN-2026. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. WAS THE PRODUCT INSPECTED FOR DAMAGE BEFORE USE? YES. WHAT WAS THE TARGET LOCATION? ERCP. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? JAGWIRE .035INCH 260CM. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS DUODENOSCOPE 4.2WC. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY? NOT ALTERED. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? DEPLOYMENT WAS STARTED, WANTED TO REPOSITION THE STENT, BUT DID NOT WORK ANYMORE. WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? MAX 4CM. WAS THE SAFETY WIRE REMOVED? IF YES, AT WHAT POINT WAS IT REMOVED? NO. WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? UNKNOWN. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? UNKNOWN. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? 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. WHAT WAS THE POSITION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111471 ↗
• MalfunctionNov 4, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 18-DEC-25.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465138 ↗
• MalfunctionOct 29, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 11 DEC 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420853 ↗
• MalfunctionSep 25, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A 62-YEAR-OLD FEMALE PATIENT UNDERWENT A BILE DUCT/COMMON BILE DUCT PROCEDURE IN WHICH THE EVOLUTION BILIARY CONTROLLED-RELEASE STENT-UNCOVERED, G23130, WAS USED. ONCE THE PROSTHESIS WAS RECAPTURED TO BE REPOSITIONED IN THE BILE DUCT, IT DID NOT DEPLOY AGAIN, EVEN THOUGH ALL THE STEPS FOR ITS CORRECT USE WERE FOLLOWED. ONCE IT WAS OUT, WE NOTICED THAT THE PROSTHESIS CATHETER WAS DETACHED FROM ITS COVERING. REMOVAL OF THE STYLET WAS DIFFICULT ONCE THE POINT OF NO RETURN HAD BEEN PASSED. ASSISTANCE IN PROCEDURE AND PROSTHESIS INSTALLATION. ADDITIONAL INFORMATION RECEIVED: 12-SEP-2025. 1. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? R: DUODENOSCOPIO MARCA OLYMPUS, CANAL DE TRABAJO DE 4.2 MM. 2. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? R: GUÍA BILIAR METII-35-480 COOK MEDICAL (0.035¿ X 480 CM). 3. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. R: VÍA BILIAR. 4. WERE ANY DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? N/A, YES, NO. R: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23144525 ↗
• MalfunctionAug 14, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE TRIGGER MECHANISM GOT JAMMED & THE STENT COULD NOT BE OPENED / DEPLOYED PROPERLY PATIENT/EVENT INFO - NOTES: QUERY REPLY_24.07.24 1. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? WHILE INSERTING THE EVOLUTION IN THE PATIENT, DURING STENT PLACEMENT - DURING STENT PLACEMENT 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED - OLYMPUS 3. WHAT WAS THE POSITION OF THE ELEVATOR? OPEN 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? N/A, 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. BILIARY TREE 8. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? N/A 9. FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION COMPLETED? N/A 10. IF YES, HOW OFTEN WAS THIS COMPLETED? 11. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? N/A 12. WHAT INTERVENTION (IF ANY) WAS REQUIRED? 13. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981146 ↗
• MalfunctionNov 3, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  6 CM STRICTURE FROM MID CBD TO THILAR WARE CROSSED THROUGH THE STRICTURE AND DILATATED WITH SBDC-6 7 & 9. THEN STENTING STARTED DURING REPOSITIONING OF THE STENT THE CATHETER GOT STUCK, WHILE PULLING BACK IT GOT STRETCHED, PROCEDURE COMPLETE WITH 8CM. QUERY REPLY : GENERAL QUESTIONS. 1. DURING THE PLACEMENT. 2. OLYMPUS 190 SERIES SCOPE , 4.2 MM CHANNEL SIZE. 3. ELEVATOR IS NOT USED. 4. TRACER METRO 0.35 COOK. 5. NA. 6. NO. 7. MID CBD. 8. NOT ABLE TO DEPLOY THE STENT. 9. NA. 10. NA. 11. YES. 12. DEPLOYED ANOTHER STENT EVO-B. 13. SAME TIME . 14. NA. 15. NA. STRICTURE INFORMATION. 1. MID CBD TO HILAR .APPROX 5 CM. 2. C BD. 3. NO. 4. YES. 5. YES. DURING INSERTION. 1. NO DAMAGE. 2. YES. 3. WHEN THE STENT CROSSED ACROSS THE LESION. DURING THE STENT PLACEMENT. 1. DEPLOYMENT. 2. NA. 3. NO. 4. NO. 5. YES. 6. YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065839 ↗
• MalfunctionAug 15, 2023Difficult to Advance; Difficult to Advance

  CUSTOMER GOT IN TOUCH TO SAY THAT AFTER REMOVING PROSTHESIS, IT WAS IMPOSSIBLE TO WITHDRAW THE GUIDE. THE WHOLE THING WAS TAKEN OUT AND ANOTHER .STENT WAS USED IN IT'S STEAD. CUSTOMER SAYS THAT ITEM IS AVAILABLE AND ALSO NOT SO WILL HAVE TO CONFIRM.

  Patient problems: Insufficient Information

  MAUDE report 17547713 ↗
• InjuryJul 14, 2023Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE RECEIPT OF CUSTOMER COMPLAINT FORM AND ADDITIONAL INFORMATION RECEIVED 12-JUL-2023. THIS RESULTED IN AN UPDATE TO ANNEX E AND F CODES. CUSTOMER FOUND IT HARD TO RETRIEVE CATHETER AFTER DROPPING PROSTHESIS WHICH RESULTED IN ITS DEFORMATION AND MEANT REPLACING THE PROSTHESIS AS PER CUSTOMER COMPLAINT FORM: "DIFFICULTY TO REMOVE THE CATHETER OF THE STENT. THEY PROBABLY FORGOT TO REMOVE THE SAFETY WIRE." 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 WAS PLACED. 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? WHILE REMOVING THE INTRODUCER. 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? 4.2MM. 3. WHAT WAS THE POSITION OF THE ELEVATOR? OPEN. 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? JAGWIRE 0.035. 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? YES. 7. PLEASE ADVISE THE

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324844 ↗
• MalfunctionMar 6, 2023Break; Break

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485088 ↗
• MalfunctionMar 15, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  CABLE BENT AND BROKEN IN 2 PLACES ( STORED IN ITS SECONDARY PACKAGING THEREFORE NOT LINKED TO OUR STORAGE CONDITIONS ) THE STENT WAS PLACED WITH AN AMBU DUODENOSCOPE "AS PER CC FORM": IMPLATATION OF AN EVOLUTION STENT FOR INTRAHEPATIC STENOSIS. WHEN THE STENT IS RELEASED, THE TRIGGER HAS HARD/DIFFICULT AND IT IS BLOCKED (SOUND OF "CLAC" IN THE GUN). ANALYSIS OF THE FLEXOR ON WITHDRAWAL: KINKING IN MANY PLACES. LAB EVALUATION COMPLETED ON: 02 MAR 2022. VISUAL INSPECTION: FLEXOR BREAKAGE OBSERVED APPROXIMATELY 128CM FROM WHITE TIP. LOCK WIRE IN PLACE ON RETURN. RED MARKER AT 7TH DIMPLING ON HANDLE. STENT IS PARTIALLY DEPLOYED ON RETURN. FUNCTIONAL INSPECTION: HANDLE ACTUATING FINE. UNABLE TO DEPLOY THE STENT DUE TO FLEXOR BREAKAGE. 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 GENERAL QUESTIONS: AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? DURING STENT PLACEMENT, WHILE REMOVING THE INTRODUCER. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? AMBU ENDOSCOPE DISPOSABLE WHAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13769787 ↗
• MalfunctionMar 31, 2020Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  THE INTRODUCER SYSTEM BROKE DOWN AND THE STENT WAS NOT ABLE TO BE RELEASED FULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9902126 ↗
• MalfunctionMar 14, 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'. STENT NOT RELEASING DURING TRIGGERING COULD NOT BE DEPLOYED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8420537 ↗
• MalfunctionNov 27, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE "FLEXOR KINKED/ STRETCHED/ BROKE/ COMPRESSED." IMPOSSIBLE TO DEPLOY THE STENT IN THE BILIARY DUCT. "AS PER COMPLAINT FORM": AFTER SPHINCTEROTOMES AND INSERTION OF 2 ACROBAT 2 ; THE PHYSICIAN DILATED THE RIGHT AND LEFT PART OF THE BILE DUCT. THEY HAD SOME DIFFICULTIES DURING THE INSERTION OF THE STENT INTO THE CORRECT POSITION. THEY START TO DEPLOY THE FIRST STENT, AT THIS TIME THEY HEARD A NOISE IN THE HANDLE. IMPOSSIBILITY TO DEPLOY THE STENT (NOTHING HAPPENED WHEN THEY PUSH THE TRIGGER. THEY TOOK ANOTHER ONE AND THE SAME ISSUE HAPPENED. THEY FINISHED THE PROCEDURE WITH 2 STENTS FROM COMPETITORS. OUTSIDE IT'S SEEMS THAT THE STENT COULD DEPLOYED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8105087 ↗
• InjuryJul 30, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  TWO ADDITIONAL FILES WERE OPENED IN RELATION TO THIS INCIDENT. THIS FILE WILL ADDRESS THE SECOND STENT AND IS BEING REPORTED UNDER THE REQUIREMENT FOR SURGICAL INTERVENTION AS THE DOCTOR HAD TO USE A THIRD "WALLFLEX" STENT AFTER THE SECOND EVOLUTION STENT DID NOT DEPLOY IN THE CORRECT LOCATION FOLLOWING DIFFICULTIES DURING DEPLOYMENT. TWO DEVICES IMPLICATED. THERE WAS A DIFFICULTY DURING THE RELEASE OF THE 2 STENTS: PARTIAL DEPLOYMENT OF THE STENTS IN COMPARISON WITH THE CURSOR OF THE HANDLE WHICH REACHED THE END. DEVICES HAS BEEN DISCARDED. THE PATIENT IS FINE "AS PER COMPLAINT FORM": FIRST OF ALL, THE FIRST WIRE GUIDE VISIGLIDE IN 0.025" WAS PLACED IN THE LEFT ( HARDER SIDE) AND THEN THE JAG WIRE IN THE RIGHT SIDE. THEN, DILATION IN THE RIGHT AND IN THE LEFT SIDE WITHOUT PROBLEM AND GOOD DILATION OF BOTH SIDE. THE DOCTOR DECIDED TO PLACE FIRST THE STENT IN THE LEFT SIDE BECAUSE IT WAS THE HARDER ( QUITE ANGLED AS USUAL ). THEY PLACE THE STENT WITH A BIT OF DIFFICULTY IN THE AREA OF STENOSIS BUT CAN GET THROUGH THE TUMOUR AND STARTED THE DEPLOYMENT . MAYBE BECAUSE OF ANGULATION, THE NURSE HAD STARTED THE DEPLOYMENT WITH THE HAND BUT THE STENT HAD DIFFICULTY TO GET OUT OF THE SHEAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7730501 ↗
• MalfunctionJul 27, 2018Material Deformation; Material Deformation

  2 DEVICES IMPLICATED. THERE WAS A DIFFICULTY DURING THE RELEASE OF THE 2 STENTS: PARTIAL DEPLOYMENT OF THE STENTS IN COMPARISON WITH THE CURSOR OF THE HANDLE WHICH REACHED THE END. DEVICES HAS BEEN DISCARDED. THE PATIENT IS FINE. THIS REPORT ADDRESSES THE FLEXOR ISSUE WITH THE FIRST STENT. "AS PER COMPLAINT FORM": FIRST OF ALL, THE FIRST WIRE GUIDE VISIGLIDE IN 0.025" WAS PLACED IN THE LEFT ( HARDER SIDE) AND THEN THE JAG WIRE IN THE RIGHT SIDE. THEN, DILATION IN THE RIGHT AND IN THE LEFT SIDE WITHOUT PROBLEM AND GOOD DILATION OF BOTH SIDE. THE DOCTOR DECIDED TO PLACE FIRST THE STENT IN THE LEFT SIDE BECAUSE IT WAS THE HARDER ( QUITE ANGLED AS USUAL ). THEY PLACE THE STENT WITH A BIT OF DIFFICULTY IN THE AREA OF STENOSIS BUT CAN GET THROUGH THE TUMOUR AND STARTED THE DEPLOYMENT . MAYBE BECAUSE OF ANGULATION, THE NURSE HAD STARTED THE DEPLOYMENT WITH THE HAND BUT THE STENT HAD DIFFICULTY TO GET OUT OF THE SHEATH. THEY RECAPTURED IT BECAUSE THEY DIDN'T HAVE SO MUCH PLACE TO MANOEUVRE ( 10 CM IN LENGTH WAS A LITTLE FAIR, 12 CM HAD BEEN BETTER ) BUT NO DIFFICULTIES TO RECAPTURE. WHEN THEY STARTED OVER, THE STENT WAS NOT COMPLETELY DEPLOYED AND THE NURSE HAD ARRIVED AT THE END OF THE HA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7726150 ↗
• InjuryJul 27, 2018Material Deformation; Material Deformation

  TWO ADDITIONAL FILES WERE OPENED IN RELATION TO THIS INCIDENT. THIS FILE WILL ADDRESS THE SECOND FAILURE MODE FOR THE FIRST STENT. THE INNER CATHETER BREAK AND THE NEED FOR RETRIEVAL. TWO DEVICES IMPLICATED. THERE WAS A DIFFICULTY DURING THE RELEASE OF THE 2 STENTS: PARTIAL DEPLOYMENT OF THE STENTS IN COMPARISON WITH THE CURSOR OF THE HANDLE WHICH REACHED THE END. DEVICES HAS BEEN DISCARDED. THE PATIENT IS FINE. "AS PER COMPLAINT FORM": FIRST OF ALL, THE FIRST WIRE GUIDE VISIGLIDE IN 0.025" WAS PLACED IN THE LEFT (HARDER SIDE) AND THEN THE JAG WIRE IN THE RIGHT SIDE. THEN, DILATION IN THE RIGHT AND IN THE LEFT SIDE WITHOUT PROBLEM AND GOOD DILATION OF BOTH SIDE. THE DOCTOR DECIDED TO PLACE FIRST THE STENT IN THE LEFT SIDE BECAUSE IT WAS THE HARDER (QUITE ANGLED AS USUAL). THEY PLACE THE STENT WITH A BIT OF DIFFICULTY IN THE AREA OF STENOSIS BUT CAN GET THROUGH THE TUMOUR AND STARTED THE DEPLOYMENT. MAYBE BECAUSE OF ANGULATION, THE NURSE HAD STARTED THE DEPLOYMENT WITH THE HAND BUT THE STENT HAD DIFFICULTY TO GET OUT OF THE SHEATH. THEY RECAPTURED IT BECAUSE THEY DIDN'T HAVE SO MUCH PLACE TO MANOEUVRE (10 CM IN LENGTH WAS A LITTLE FAIR, 12 CM HAD BEEN BETTER) BUT NO DIFFICULTIES TO

  Patient problems: Foreign Body In Patient

  MAUDE report 7725804 ↗
• MalfunctionSep 20, 2017Delivery System Failure; Delivery System Failure

  AFTER WIRE GUIDE PLACEMENT AND SPHINCTEROTOMY THEY WANTED TO PLACE AN EVO-B. THEY HARD A NOISE INTO THE HANDLE WITH THE IMPOSSIBILITY TO DEPLOY THE STENT. THEY PUT IN A NEW ONE WITH SUCCESS. UPDATE OF THE DESCRIPTION: THEY STARTED TO DEPLOYED THE STENT WHEN THEY HEARD THE NOISE IN THE HANDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6879215 ↗
• MalfunctionJul 12, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE CATHETER COULDN'T BE RELEASED SO STENT COULDN'T BE EXPOSED FULLY AS PER COMPLAINT FORM: THE CATHETER COULDN'T BE RELEASED SO STENT COULDN'T BE EXPOSED FULLY. THE CATHETER SYSTEM AND THE STENT WERE THEN COMPLETELY REMOVED FROM THE PATIENT AND FROM THE SCOPE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6705085 ↗