Evolution G23129Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10827002231297), received between Nov 17, 2016 and Sep 29, 2026 — classified as 9 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (12 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933427 ↗
• MalfunctionMay 20, 2026Material Twisted/Bent

  AFTER THE NURSE OPENED THE PACKAGE, THE STENT DELIVERY SYSTEM WAS ADVANCED OVER THE GUIDEWIRE THROUGH THE ENDOSCOPE AND POSITIONED IN THE COMMON BILE DUCT. WHEN THE OPERATOR ATTEMPTED TO DEPLOY THE STENT, A CRACK WAS NOTED IN THE DELIVERY-SYSTEM HANDLE; MANIPULATING THE TRIGGER WAS DIFFICULT AND INTERFERED WITH OPERATION. THE DEVICE WAS RETRACTED, A NEW LIKE STENT WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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? - OLYMPUS JF260V. WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? - CLOSED. WHAT WAS THE TARGET LOCATION? - COMMON BILE DUCT. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? - METII-35-480. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? - YES. DID ANY PART OF THE STENT CONTACT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25237393 ↗
• MalfunctionMar 23, 2026Break; Failure to Advance

  THE PROSTHESIS COULD NOT BE RELEASED INSIDE THE PATIENT. IT BECAME STUCK, AND A BROKEN THREAD IS VISIBLE. WHEN THEY TRIED TO REMOVE THE PROSTHESIS FROM THE PATIENT, IT WAS NOT POSSIBLE TO DEPLOY IT WAS STUCK, AND A BROKEN THREAD WAS VISIBLE. THEY THEN REMOVED IT AND INSERTED A SECOND PROSTHESIS. WAS THE PRODUCT INSPECTED FOR DAMAGE BEFORE USE? - NO WHAT WAS THE TARGET LOCATION? - MAJOR DUODENAL PAPILLA DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? - METII-35-260 WAS THE WIRE GUIDE INSPECTED FOR DAMAGE BEFORE USE? - N/A WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? - N/A WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? - 4,2MM DUODENOSCOPE. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY? - NO WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? - NO WAS AN ASSESSMENT CARRIED OUT TO DETERMINE TO NECESSITY FOR PRE-DILATION? - N/A WAS THE SAFETY WIRE REMOVED? IF YES, AT WHAT POINT WAS IT REMOVED. - NO, BECAUSE THE PROBLEM WAS AT THE BEGINNING OF THE RELEASE OF THE STENT WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? - NO IF RESISTANCE WAS FELT HOW DID THE PHYSICIAN DEAL WITH THE RESISTANCE ENCOUNTERED? WAS RESISTAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24668213 ↗
• MalfunctionFeb 3, 2026Break; No Apparent Adverse Event

  DOSSIER (B)(4): CUST'S EMAIL TO SSC PROD:14-JAN-26 16H43. THE CATHETER BENT BEFORE INSERTION. THE CATHETER BROKE IN TWO AT THE POINT WHERE IT WAS FOLDED, PREVENTING THE STENT FROM BEING LAUNCHED. STENT SIZE CHANGE: THE DEVICE THAT BROKE HAD AN 8 CM LONG STENT. ANOTHER DEVICE WITH A 10 CM LONG STENT WAS USED. "AS PER CC FORM": THE CATHETER BECAME TWISTED BEFORE INSERTION. THE CATHETER BROKEN TWO AT THE KINK, PREVENTING THE RELEASE OF THE PROSTHESIS. MORE DETAILS WILL COME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250492 ↗
• MalfunctionApr 28, 2025Break; Difficult to Advance; Break; Difficult to Advance

  USER SUCCESSFULLY COMPLETED THE CANNULATION AT DUODENAL PAPILLA, AND WIRE GUIDE PLACED IN RIGHT HEPATIC DUCT, THEN EXCHANGED THE WIRE GUIDE AND KEEP WIRE GUIDE IN PLACE. USER OPENED THE DEVICE PACKAGE AND CHECKED THE DEVICE INTEGRITY, AND READY TO ADVANCE THE DEVICE THROUGH WIRE GUIDE INTO ENDOSCOPE WORKING CHANNEL WHILE FOUND OUT THE WIRE GUIDE ADVANCEMENT DIFFICULTY, AFTER SEVERAL ATTEMPTS USER ADVANCED WIRE GUIDE TO DUODENAL PAPILLA ENTRANCE AND INTO DUODENAL PAPILLA TO PROXIMAL END OF STENOSIS AREA WHILE FOUND OUT THE WIRE GUIDE ADVANCEMENT DIFFICULTY THROUGH STENOSIS AREA, AFTER SEVERAL ATTEMPTS THE SHEATH KINK THEN BROKEN, USER CATCH THE SHEATH THAT OUTSIDE OF ENDOSCOPE AND RETRACTED THE DEVICE ALONG WITH ENDOSCOPE FROM PATIENT. USER CHANGED TO ANOTHER 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. UPDATED ON 8APR2025 CAN IT BE EXPLAINED FURTHER WHAT IS MEANT BY THIS LINE IN THE DESCRIPTION OF EVENT? WERE 2 WIRE GUIDES USED? ¿WIRE GUIDE PL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917149 ↗
• MalfunctionJan 16, 2025Material Twisted/Bent; Material Twisted/Bent

  WHEN RELEASING, SNAPPING AND THEN IMPOSSIBLE TO RELEASE THE PROSTHESIS, BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21175710 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON (B)(6)2025.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20817421 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2019 DATE OF FIRST IMPLANT PROCEDURE IN COMMON BILE DUCT. NO ADVERSE EVENTS RELATED TO THE PROCEDURE. NOT DOCUMENTED IF FLUOROSCOPY WAS USED. RE-CURRENT BILIARY OBSTRUCTIONS (B)(6) 2020. AT 142 DAYS POST-PROCEDURE. DUE TO TISSUE OR TUMOR INGROWTH. NO SIGNS/SYMPTOMS. TREATMENT ENDOSCOPIC INTERVENTION NEW STENT INSIDE STUDY STENT AND ANTIBIOTICS. THE SITE DETERMINED THE EVENT TO NOT BE RELATED TO THE STUDY DEVICE OR PROCEDURE. PATIENT DEATH (B)(6) 2020 DUE TO PROGRESSION PANCREATIC CANCER. THE REINTERVENTION WAS NOTED TO BE SUCCESSFUL. ON (B)(6) 2020, THE PATIENT DIED. THE CAUSE OF DEATH WAS PRIMARY DISEASE PROGRESSION. DASH SPHINCTEROTOME USED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20786295 ↗
• MalfunctionNov 5, 2024Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  WHEN TRYING TO USE THE METAL PROSTHESIS, IT WAS FOUND THAT IT WAS NOT POSSIBLE TO FIRE THE PROSTHESIS. PATIENT OUTCOME: NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610488 ↗
• MalfunctionAug 27, 2024Material Twisted/Bent; Material Twisted/Bent

  USER ADVANCED THE STENT DELIVERY SYSTEM THROUGH ENDOSCOPE AND WIRE GUIDE TO DESIRED POSITION, THEN PULLED THE TRIGGER TO DEPLOY THE STENT, BUT FOUND OUT THE STENT CANNOT BE DEPLOYED. USER RETRACTED THE DELIVERY SYSTEM AND CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. 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. 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 A NEW ONE TO COMPLETE THE PROCEDURE. FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK: 3. HAD A SPHINCTEROTOMY BEEN PERFORMED PRIOR TO THIS OCCURRENCE? YES 4. HAD DILATION OF THE OBSTRUCTED AREA BEEN PERFORMED PRIOR TO THIS OCCURRENCE? YES 5. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? OLYMPUS TJF-260V OLYMPUS TJF-260V 6. PLEASE DESCRIBE THE LOCATION IN THE BODY WHERE THE STENT WAS TO BE PLACED. COMMO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076718 ↗
• MalfunctionJul 4, 2024Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  DESCRIPTION OF EVENT: STENT COULD NOT BE PULLED OUT DURING ERCP. AS PER CUSTOMER COMPLAINT FORM: "THE SYSTEM WAS ALREADY PLACED IN THE CORRECT PLACE, BUT THE STENT COULD NOT BE PLACED (DID NOT MOVE FROM THE SPOT EVEN THOUGH THE TRIGGER WAS PRESSED SEVERAL TIMES). A LITTLE KINK OR ABRASION WAS NOTICED ON THE CATHETER BEFORE INSERTING.PROCEDURE WAS FINISHED WITH A NEW EVO STENT. " PATIENT CAME WITH A PLASTIC STENT (BOSTON SCIENTIFIC ADVANIX BILIARY), WHICH THEY DECIDED TO REMOVE AND CHANGE TO AN EVOLUTION METAL STENT. THE PLASTIC STENT WAS ALREADY REMOVED WHEN THE INCIDENT OCCURRED. 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: STENT PLACEMENT. 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19674171 ↗
• MalfunctionDec 13, 2023Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THIS BILIARY SEMS DID NOT DEPLOYED INSIDE COMMON BITE DUCT WHILE DOING ERCP. QUERY REPLY: AS IT COULDN'T BE DEPLOYED AT THE DESIRED SITE-CBD DUE TO TECHNICAL DIFFICULTY. QUERY REPLY: GENERAL QUESTIONS: 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 WHILE REMOVING THE INTRODUCER 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS & CHANNEL = 3.2MM 3. WHAT WAS THE POSITION OF THE ELEVATOR? N/A, OPEN, CLOSED OPEN 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? 0.035 MET WIRE 5. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? N/A, YES, NO YES 6. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? N/A, YES, NO NO 7. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. COMMON BILE DUCT 8. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? LESS THAN A MINUTE 9. FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION COMPLETED?

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

  MAUDE report 18318424 ↗
• MalfunctionDec 8, 2023Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 22-OCT-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290257 ↗
• MalfunctionMay 24, 2023Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 03-JAN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991260 ↗
• MalfunctionDec 8, 2022Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  IN DOING COUNT AND TOLD THAT LOT C1958996 (THAT WAS BILLED YESTERDAY ) HAD A PROBLEM. PC = THEY WENT DOWN THE SCOPE WITH THE STENT. WHEN THEY STARTED TO DEPLOY IT WOULDN'T DEPLOY. STENT APPEARS JAMMED. PRODUCT RETURNING FOR ANALYSIS. AS PER CC FORM: "THE STENT WAS DEPLOYED OVER THE WIRE DOWN THE SCOPE BUT WHEN THE NURSE STARTED TO DEPLOY IT IT WOULD NOT GO PAST A CERTAIN POINT REGARDLESS IF IT WAS RETRACTED OR NOT." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THEY HAD TO USE AN ADDITIONAL STENT TO COMPLETE THE CASE 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? 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 PLACEMENT . WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? AQUILANT DUODENAL SCOPE SERIAL NUMBER (B)(4). WHAT WAS THE POSITION OF THE ELEVATOR? N/A, OPEN, CLOSED N/A. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? AWG2 0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940355 ↗
• MalfunctionApr 28, 2022Activation, Positioning or Separation Problem; Material Twisted/Bent; Activation, Positioning or Separation Problem; Material Twisted/Bent

  WHEN THE DOCTOR TRIED RECAPTURED THE STENT WAS NOT POSSIBLE TO DO IT CORRECTLY AND THEY NEED IMPLANT ANOTHER ONE "AS PER CC FORM": THEY INTRODUCED THE WIRE, AFTER THE STENT BUT WAS A BIG STENOSIS, THEY STARTED TO OPEN, AFTER THEY TRIED TO RECOVER THE STENT TO REPLACE IN A HIGHER POSITION BUT IT WAS NOT POSSIBLE TO CLOSE THE STENT TOTALLY AND CONTINUE USING THE SYSTEM LAB EVALUATION COMPLETE ON 25-APR-2022: VISUAL INSPECTION: STENT PARTIALLY DEPLOYED ON RETURN. MARKER BETWEEN 3RD AND 4TH DIMPLING. LOCK WIRE IN PLACE ON RETURN. FLEXOR (CLEAR SECTION) KINKED APPROXIMATELY 12CM FROM THE TIP. FUNCTIONAL INSPECTION: ADVANCEMENT AND RECAPTURE WAS POSSIBLE. LOCK WIRE REMOVED AND STENT DEPLOYED WITH SOME RESISTANCE 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 = REPOSITIONING THE STENT 2. WHAT ENDOSCOPE TYPE AND CHA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14235970 ↗
• MalfunctionDec 3, 2021Break; Break

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

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

  MAUDE report 12922340 ↗
• MalfunctionApr 15, 2021Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  USER DEPLOY THE STENT ABOUT 2-3 CM ,AND THE STENT NO LONGER CAN BE DEPLOYED. USER RETRACTED THE DEVICE FROM PATIENT. DEVICE EVALUATED 09-APR-21: "FLEXOR KINKED" GENERAL QUESTIONS: 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) INSERTING THE EVOLUTION IN THE PATIENT. EVOLUTION¿EVOLUTION WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS JF-260V WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? UNKNOWN DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? BOSTON SCIENTIFIC WIRE GUIDE 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? 3 MINUTES FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION COMPLETE AND HOW OFTEN? IFU UNKNOWN STRICTURE INFORMATION: WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? UNKNOWN WHERE WAS THE STRICTURE LOCATED IN THE BODY? BILE DUCT WAS THERE RESISTANCE FELT PASSING WIRE GUIDE THR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11669783 ↗
• MalfunctionDec 15, 2020Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE INVESTIGATION BEING COMPLETED ON 20-MAY-2021.

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

  MAUDE report 11008781 ↗
• InjuryNov 17, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 13OCT2022.

  Patient problems: Inflammation

  MAUDE report 10849886 ↗
• MalfunctionNov 10, 2020Break; 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 10820414 ↗
• MalfunctionSep 24, 2020Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; 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 Consequences Or Impact To Patient

  MAUDE report 10582858 ↗
• InjuryAug 20, 2020Break; Break

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO ADDITIONAL INFORMATION BEING RECEIVED ON 27AUG2020. ADDITIONAL INFORMATION PROVIDED BY CUSTOMER ON 27AUG3020: " DID THE RED INDICATOR MOVE WHEN THE TRIGGER WAS PRESSED? YES IT WAS. DID THE RED INDICATOR CONTINUE TO MOVE AFTER THE DELIVERY STOPPED? NO IT WASN´T WERE ANY CRACKING/POPPING SOUNDS HEARD FROM THE HANDLE? YES IT WAS , A CRACKING SOUNDS HEARD. WAS THE STENT PARTIALLY EXPOSED? THE STENT WAS INSIDE THE CATHETER WITHOUT PROBLEM. IF THE STENT WAS PARTIALLY EXPOSED, WAS IT POSSIBLE TO RECAPTURE THE STENT FULLY BEFORE REMOVAL? WHAT IS THE PATIENT OUTCOME? THE DOCTOR USED ANOTHER STENT AND THE PATIENT PRESENTED PAIN." PATIENT OUTCOME: 1. DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? YES. IF YES, PLEASE DESCRIBE. THE INTERNAL CATHETER OF THE EVOLUTION DEVICE REMAINS ATTACHED IN COLEDOCO TOGETHER WITH THE PROSTHESIS RELEASED, IT IS CAREFULLY REMOVED WITHOUT ANY PROBLEM, THERE IS NO PATIENT DAMAGE. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? IF YES, PLEASE DESCRIBE. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? YES IF YES, PLEASE DESCRIBE. TH

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion; Pain

  MAUDE report 10433791 ↗
• InjuryAug 6, 2020Fracture; Fracture

  THE DOCTOR REPORTS THAT THE PROSTHESIS RELEASED CORRECTLY. AT THE TIME OF REMOVING THE DEVICE AND REVISING, IT WAS NOTED THAT THE PROSTHESIS WAS IN A DIFFERENT POSITION FROM THE INITIAL. AN ENDOSCOPIC REVIEW OBSERVED A PIECE OF THE INTERNAL CATHETER OF THE RELEASE DEVICE AND THE DOCTOR WAS ABLE TO REMOVED IT . AFTERWARDS THE DOCTOR DECIDED TO PLACE ANOTHER METALLIC PROTHESIS WITHOUT ANY ISSUES.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 10373012 ↗
• MalfunctionJan 20, 2020Material Integrity Problem; Material Integrity Problem

  AS PER SOURCE DOC: "TODAY, ENDOSCOPY LETS ME KNOW THAT THEY HAD PROBLEMS WHEN INSTALLING AN EVO-10-11-8-B ENDOPROSTHESIS LOT: C1685213 EXPIRATION: 21/11/21. IN FACT, DURING IMPLANTATION IN THE PATIENT, SHE DID NOT WANT TO DROP, ON THE CONTRARY, SHE SANK INTO THE SHEATH CAUSING IT TO SWELL. THE TEAM HAS DISINFECTED, IT IS IN MY OFFICE IN ITS ORIGINAL BOX. FOR MORE INFORMATION, CONTACT THE PHARMACIST AND THE ENDOSCOPY MANAGER. DO YOU PLAN TO RETRIEVE IT FOR ANALYSIS?" CC FORM: CUSTOMER OPENED SEALED PACKAGE AND REMOVED STENT WITHOUT PROBLEM STENT SEEMED GOOD. DR MADE CUT THE PAPILLA WITH PRE-CUT NEEDLE AND INSERTED JAGWIRE INTO THE BILIARY DUCT. STENT WAS INTRODUCED INTO THE PENTAX DUODENOSCOPE THROW OPERATING CHANNEL WITHOUT PROBLEM. WHEN THEY WERE IN GOOD POSITION THEY PRESSED DEPLOYMENT BUTTON BUT NOTHING HAPPENED. DEPLOYMENT WAS IMPOSSIBLE BUTTON SEEMED BLOCKED. THEY REMOVED ALL THE SYSTEM AND TOOK STENT FROM ANOTHER COMPANY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9605678 ↗