Zilver 635 G50621Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10827002506210), received between Dec 19, 2016 and Jun 2, 2026 — classified as 5 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (9 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Premature Activation

  AFTER INSERTING THE ZILVER STENT DELIVERY SYSTEM INSIDE THE CBD , WHILE ASSESING THE LENGTH OF THE STRICTURE AND STENT , IT WAS FOUND THE THERE IS NEED OF 8CM STENT INSTEAD OF 6CM.WHILE REMOVING THE ZILVER 6CM STENT, IT GOT AUTOMATICALLY DEPLOYED TILL HALF POINT WITHOUT EVEN REMOVING THE SAFETY LOCK. PATIENT/EVENT INFO - NOTES DO THEY KNOW WHY THE STENT GOT PREMATURELY DEPLOYED DURING RETRACTION? NO. WHAT ENDOSCOPE CHANNEL SIZE WAS USED? OLYMPUS 150 SERIES ERCP SCOPE ACCESORY CHANNEL SIZE 4.2MM. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER)? VISIGLIDE .35. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? NO. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM (E.G., KINKS) PRIOR TO RETURN? NO. IF ADDITIONAL INTERVENTION WAS PERFORMED, WAS IT DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? 8CM ZILVER DEPLOYED AT SAME TIME IN SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360790 ↗
• MalfunctionDec 24, 2025Premature Activation; Premature Activation

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 04-FEB-26.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887660 ↗
• InjuryNov 14, 2025Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT THE STENT FRACTURED AND FELL INTO THE INTESTINAL LUMEN ONE YEAR AFTER PLACEMENT, CAUSING INTESTINAL OBSTRUCTION, NECESSITATING PARTIAL ILEAL RESECTION. ON (B)(6) 2025: SEPARATION OF ABDOMINAL ADHESIONS AND PARTIAL ILEAL RESECTION. COMMUNICATION WITH PRODUCT MANAGER WHO MENTIONED THE PATIENT AND FAMILY WANTS COMPENSATION DUE TO THIS EVENT (STENT BROKEN), NO OFFICIAL REQUEST SO FAR FROM DISTRIBUTOR/USER FACILITY. PROCEDURE DETAIL UPDATED ON (B)(6) 202056 FROM AN IMAGE FROM USER FACILITY COMPUTER SCREEN: DIAGNOSIS: 1. TERMINAL ILEAL ADHESION TORSION WITH SMALL BOWEL STENT FOREIGN BODY CAUSING ACUTE INTESTINAL OBSTRUCTION 2. HIGH LIKELIHOOD OF DISTAL COMMON BILE DUCT CARCINOMA 3. HYPOKALEMIA 4. STAGE 1 HYPERTENSION (MODERATE RISK) 5. MULTIPLE CYSTS IN LEFT HEPATIC LOBE 6. LEFT RENAL CYST? 7. HYPOPROTEINEMIA 8. BRADYCARDIA; 9. POSTOPERATIVE STATUS: BILIARY ASCARIASIS, CHOLECYSTECTOMY, HYSTERECTOMY, BILIARY STENT PLACEMENT, PANCREATIC DUCT STENT PLACEMENT; 10. MULTIPLE SMALL NODULES IN BOTH LUNGS; 11. LUMBAR SCOLIOSIS; 12. BILIARY DISTENSION SYNDROME - LIVER QI STAGNATION. PROCEDURE NAME: LAPAROSCOPIC PARTIAL ILEAL RESECTION + LAPAROSCOPIC ADHESIOLYSIS + LAPAROSCOPIC

  Patient problems: Foreign Body In Patient

  MAUDE report 23559695 ↗
• MalfunctionOct 28, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13-NOV-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401775 ↗
• MalfunctionJan 23, 2025Break; Activation Failure; Break; Activation Failure

  DURING THE PROCEDURE, WHEN DOCTOR STARTED DEPLOY STENT & PULLED THE OUTER CATHETER BUT STENT DID NOT DEPLOYED , THEN HE WITHDRAW THE DELIVERY SYSTEM AND AGAIN TRIED, SAME THING HAPPENED AGAIN, THEN AGAIN WITHDRAWN THE SYSTEM AND CHECK OUTSIDE WHY IT NOT DEPLOYING THAT TIME IT OPENED ON THE TABLE IN THIS CASE DOCTOR DEPLOYED BOSTON STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217811 ↗
• MalfunctionDec 19, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 5 JUN 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20975734 ↗
• MalfunctionOct 1, 2024Improper or Incorrect Procedure or Method; Material Twisted/Bent; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 15 MAY 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343566 ↗
• MalfunctionAug 20, 2024Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  DISTAL PART OF THE STENT BROKEN SEEN AFTER DEPLOYMENT. REMOVE THE STENT IMMEDIATELY AND NEW STENT PLACEMENT. THE PROCEDURE COMPLETES WITH PUTTING ANOTHER STENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20003359 ↗
• MalfunctionJun 25, 2024Break; Activation Failure; Break; Activation Failure

  DESCRIPTION OF EVENT: USER ADVANCED THE STENT THROUGH OLYMPUS TJF-260 ENDOSCOPE AND WIRE GUIDE TO COMMON BILE DUCT AND PASSED THE STRICTURE AREA TO DESIRED POSITION, USER READY TO DEPLOY THE STENT, USE REMOVE THE RED SAFTY LOCK, BUT FOUND OUT THE SHEATH CANNOT BE PULLED AND THE STENT CANNOT BE DEPLOYED. USER RETRACTED THE STENT FROM ENDOSCOPE AND CHANGED TO ANOTHER SAME RPN DEVICE 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? ACRO-35-480 ACRO-35-480 2. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? WITH ANOTHER RPN DEVICE 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 AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610516 ↗
• MalfunctionMar 20, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  WHEN THE WIRE GUIDE (OLYMPUS/VISIGLIDE2 0.025INCH ANGLED) WAS INSERTED INTO THE TIP OF ZILBS-635-10-6, THE USER FELT SOMETHING WAS WRONG (IT WAS NOT INSERTED SMOOTHLY), SO HE STOPPED USING IT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SIZE (10-8)(LOT#: UNKNOWN). THIS COMPLAINT CAPTURES THE USER ERROR OF THE INCORRECT SIZE WIRE GUIDE USED ON THE COMPLAINT DEVICE. 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: <SALES REP'S COMMENT> SINCE THIS FACILITY USES THIS PRODUCT ON A REGULAR BASIS, WE DO NOT SEE ANY PROBLEM WITH ITS USAGE. 1 GENERAL QUESTIONS FOR ALL COMPLAINTS. 1-1 (IF ANY DAMAGES WERE CONFIRMED PRIOR TO USE)WAS THE PACKAGE DAMAGED? NO 1-2 (IF ANY DAMAGES WERE CONFIRMED PRIOR TO USE)HOW WAS THE DEVICE STORED? 1-3 WAS A SPHINCTEROTOMY OR BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT DEVICE? NO. 1-4 WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? NO. 1-5 WHAT BRAND OF ENDOSCOPE WAS USED WITH THE DEVICE? OLYM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18939686 ↗
• MalfunctionDec 4, 2023Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 29-MAY-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18261286 ↗
• MalfunctionNov 10, 2023Break; Mechanical Problem; Break; Mechanical Problem

  THE STENT COULD NOT BE DEPLOYED, HENCE COMPLETE WITH ANOTHER DEVICE. REPLY : 1. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A (ALREADY MENTIONED IN THE FORM). 2. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? DURING STENT PLACEMENT. 3. WAS A SPHINCTEROTOMY PERFORMED PRIOR TO USE OF THE STENT DEVICE? YES. 4. WAS BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT DEVICE? YES. 5. WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? 5 CM. 6. WHAT BRAND OF ENDOSCOPE WAS USED WITH THE DEVICE? OLYMPUS. 7. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? YES. 8. WHAT WAS THE POSITION OF THE ELEVATOR DURING DEPLOYMENT? N/A. 9. WAS THE DELIVERY SYSTEM TRACKED AROUND A TIGHT ANGLE IN THE PATIENT ANATOMY OR AROUND A TIGHT ANGLE IN AN ENDOSCOPE? NO. 10. WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? YES. 11. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, "HYDROPHILIC")? METII-35-480. 12. WHAT WAS THE TARGET LOCATION FOR THE STENT? BILIARY DUCT. 13. WAS THE RED SAFETY LOCK REMOVED BEFORE INSERTING THE DELIVERY SYSTEM? YES. 14. WAS THE RED SAFETY LOCK REMOVED BEFORE STENT DEPLOYMENT? YES. 15. WAS THE PATIENT'S ANATOMY TORTUOUS? N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18109127 ↗
• MalfunctionOct 26, 2023Improper or Incorrect Procedure or Method; Failure to Advance; Improper or Incorrect Procedure or Method; Failure to Advance

  CANCELLATION REPORT IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION RECEIVED ON 30-JAN-2024. FDA MDR REPORTING NOT REQUIRED. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK/ LOW RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18009328 ↗
• MalfunctionMar 23, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  (B)(6) DOCTOR WANTED TO INSERT METAL STENT INTO THE LEFT HEPATIC DUCT. BECAUSE THE ANGLE OF THE DUCT WAS SIGNIFICANT, THE DOCTOR DECIDED TO INSERT ZILVER635. ZILVER635-10-6 PASSED THROUGH THE LESION ALONG THE GUIDE WIRE (0.025" VISI2 STRAIGHT) LOCATED IN THE LEFT IHD. THE NURSE RELEASED THE ROCKING, AND THEY TRIED TO DEPLOY THE STENT. THERE WAS SOME RESISTANCE IN THE STENT DEPLOYMENT PROCESS, AND WHEN THE STENT CAME OUT A LITTLE FROM THE INTRODUCER SHEATH, THE END POINT OF THE COIL SHEATH BROKE. THE STENT WAS NO LONGER UNFOLDED, AND THEY REMOVED ALL OF THE ZILVER LOADED INTRODUCERS. DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT BODY? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE(S)? NO. WERE THERE ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE ADVERSE EFFECT(S)? NO. 1.0 EXAMPLES OF RPN PREFIXES (BUT NOT LIMITED TO): FS-ZILBS ZILBS. 1.1 FOR ALL COMPLAINTS, ASK: 1.1.1 WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? VISI2 0.025" STRAIGHT. 1.1.2 IF NOT, WITH THE DEVICE IN QUESTION, HOW WAS T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13859461 ↗
• MalfunctionSep 21, 2021Premature Activation; Premature Activation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509086 ↗
• InjuryJul 30, 2021Improper 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 COMPLETION OF INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12251622 ↗
• MalfunctionApr 8, 2021Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  AS REPORTED TO CUSTOMER RELATIONS VIA EMAIL "REGARDING THE WHITE PLASTIC PORTION THAT CONNECTS TO THE STENT - WHILE INTRODUCING IT TO PLACE THE STENT - THE WHITE PLASTIC PART SEPARATED WHERE THE STENT CONNECTS. THE SEPARATION CAUSED THE STENT TO KINK BACK-UP INTO THE CATHETER. THE STENT WAS NEVER FULLY DEPLOYED. THE STENT COULD NOT BE ADVANCED ANY FURTHER. A RENDEZVOUS PROCEDURE WAS PLANNED AND PERFORMED. THE RENDEZVOUS PROCEDURE WAS PERFORMED USING A COMPETITORS STENT (WHICH COMPLETED THE INTENDED PROCEDURE SUCCESSFULLY)."PATIENT OUTCOME:DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? - NO· PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED:DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? - NO· PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS:HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? - NOHAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? - NO· PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.PATIENT/EVENT INFO - NOTES: FOR ALL COMPLAINTS, REQEUST THE FOLLOWING:WAS A SPHINCTEROTOMY OR BALLOON DILATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633709 ↗
• InjuryDec 31, 2020Break; Off-Label Use; Break; Off-Label Use

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF ADDITIONAL INFORMATION AND DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS. ADDITIONAL INFORMATION RECEIVED ON THE 21-MAY-2021AS FOLLOWS: THE PATIENT INFORMATION HAS BEEN UPDATED. PATIENT DIED ON (B)(6) 2021 INITIAL REPORT DETAILS: THE ERCP PROCEDURE WAS DONE IN (B)(6), PREVIOUSLY PTCD WAS DONE TO RELIEVE THE JAUNDOUS BEFORE ERCP. AND REDZVOUS WAS ESTABLISHED VIA PTC-ERCP, ENDOSCOPIC RETROGRADE CHOANGIOGRAPHY+BILIARY BIOPSY+ METAL STENT PLANTATION WAS COMPLETED SUCCESSFULLY.THE REEXAMINATION WITHIN 5 MONTHS AFTER THE PROCEDURE SHOWED THAT THE STENT WAS OPEN WELL AND THE DRAINAGE WAS SMOOTH. THE REEXAMINATION ON DECEMBER 2 WHEN THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO FEVER FOUND THAT THE MIDDLE PART OF THE METAL STENT WAS BROKEN. THE PATIENT HAD NO OTHER SYMPTOMS AFTER THE COOLING TREATMENT, AND HE HAD ANOTHER FEVER ON DECEMBER 5. TOM PAN UPDATED THE TRANSLATION OF ORIGINAL COMPLAINT DESCRIPTION FOR REFERENCE: THE ERCP PROCEDURE WAS DONE IN JULY, PREVIOUSLY PTCD WAS DONE TO RELIEVE THE JAUNDOUS BEFORE ERCP.USER COMPLETED ERC, BILE DUCT BIOPSY AND STENT IMPLANTATION UN

  Patient problems: Fever

  MAUDE report 11100038 ↗
• MalfunctionDec 17, 2020Premature Activation; Activation, Positioning or Separation Problem; Premature Activation; Activation, Positioning or Separation Problem

  SUPPLEMENTAL FOLLOW-UP CORRECTION REPORT IS BEING SUBMITTED DUE TO THE CONFIRMATION OF THE DEVICE LOT NUMBER. THE LOT NUMBER THAT WAS INITIALLY REPORTED FOR THIS COMPLAINT WAS LOT#: C1614930, HOWEVER THE LOT NUMBER OF THE DEVICE THAT WAS RETURNED FOR EVALUATION WAS C1736472. ON 19-MAY-2021 THE LOT NUMBER WAS CONFIRMED TO BE LOT#: C1736472. INITIAL REPORT DETAILS: THE STENT PARTIALLY DEPLOYED WHEN THEY WERE FLUSHING THE FLUSH PORT PRIOR TO PATIENT CONTACT/USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COMPETITIVE DEVICE. PATIENT OUTCOME: 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? NO. 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 THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROV

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

  MAUDE report 11031855 ↗
• MalfunctionOct 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  USER OPENED THE PACKAGE, AND FOUND OUT THE STENT WAS PREMATURE RELEASED ABOUT 0.3CM. NO USE ON PATIENT. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT. LAB EVALUATION CONFIRMS RED SAFETY LOCK WAS REMOVED FROM HANDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10627202 ↗
• MalfunctionDec 19, 2019Use of Device Problem; Use of Device Problem

  THIS FILE WILL CAPTURE THE USE OF AN INCORRECT SIZE WIREGUIDE ONLY AS THIS DEVICE WAS NOT USED OFF LABEL. THIS EVENT NO LONGER MEETS THE CRITERIA OF AN FDA ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9494705 ↗
• MalfunctionDec 19, 2019Break; Break

  THE PATIENT HAD BILE DUCT CANCER WITH NORMAL ACCESS ROUTE. TWO OLYMPUS¿S 0.025 INCH WIRE GUIDES VISIGLIDE2 WERE PLACED IN B2 AND B8 RESPECTIVELY. AFTER ADVANCING A DELIVERY SYSTEM OF ZILBS-635-10-6 / C1633403 (DEVICE #2) TO B8, THE USER ADVANCED ANOTHER DELIVERY SYSTEM OF ZILBS-635-10-6 / C1633403 (DEVICE #1 COMPLAINT DEVICE) TO B2 TO PERFORM SIDE-BY-SIDE STENTING. FIRST, HE ATTEMPTED TO DEPLOY THE STENT OF DEVICE#1 FROM B2, BUT RESISTANCE PREVENTED THE STENT FROM BEING DEPLOYED. DESPITE RESISTANCE, HE CONTINUED TO WITHDRAW THE HANDLE UNTIL IT REACHED TO THE DISTAL HUB. HOWEVER, BECAUSE THE STENT APPEARED NOT TO BE DEPLOYED ON FLUOROSCOPIC SCREEN, THE DELIVERY SYSTEM OF DEVICE #1 WAS REMOVED FROM THE PATIENT AND IT WAS CONFIRMED THAT THE OUTER SHEATH WAS BROKEN AND SEPARATED AT A CERTAIN POINT. (THE STENT WAS STILL LODGED INSIDE THE DELIVERY SYSTEM.) AFTER THAT, THE STENT OF DEVICE #2 WAS DEPLOYED FROM B8, THEN THE WIRE GUIDE OVER WHICH DEVICE #1 WAS PREVIOUSLY ADVANCED WAS RE-INSERTED AND ADVANCED TO B2 THROUGH THE MESH OF THE DEPLOYED STENT OF DEVICE #2 TO PERFORM STENT-IN-STENT (SIS). ANOTHER DEVICE OF DIFFERENT SIZE WAS ADVANCED OVER THE WIRE GUIDE TO B2 AND THE STENT WAS DEPLO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9494383 ↗
• MalfunctionSep 12, 2019Fracture; Fracture

  USER OPENED THE PACKAGE AND FOUND OUT THE SHEATH SURFACE DETACHED NEAR HANDLE. NO USE ON PATIENT. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR BREAKING (INCL. FLEXOR/HANDLE SEPARATION)¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9009435 ↗
• MalfunctionAug 6, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PROTHESIS OPENED DURING THE POSITIONING FACE WITH THE LOCK STILL ON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8865027 ↗
• MalfunctionJan 9, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER ADVANCED THE DELIVERY SYSTEM TO THE TARGET SITE IN HEPATIC PORTAL REGION AND ATTEMPTED TO DEPLOY THE STENT. HOWEVER THE HANDLE WAS TOO TIGHT TO PULL TO DEPLOY THE STENT. HE REPLACED IT WITH ANOTHER STENT TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8231785 ↗