Zilver 635 G50624Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10827002506241), received between Jul 25, 2017 and Mar 30, 2026 — classified as 12 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (18 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 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Fracture

  DURING THE DEPLOYMENT OF ZILVER STENT BROKEN. ZILVER METAL STENT'S PART REMAIN INSIDE OF THE PATIENT. (B)(6) 2026 (SAME TIME) BILIARY PLASTIC STENT DEPLOYED. 1. PLEASE PROVIDE THE TRACKING INFORMATION FOR THE RETURNED DEVICE. ANS: YET NOT COURIER. 2. WHAT ENDOSCOPE CHANNEL SIZE WAS USED? ANS: 4.2MM 3. WHAT WAS THE TARGET LOCATION OF THE STENT? ANS: CBD 4. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER)? ANS: VISIGLIDE WIRE 0.025 5. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? (IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE (E.G., CHOLEDOCHOJEJUNOSTOMY)) ANS: CHOLEDOCHOJEJUNOSTOMY ANATOMY. 6. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM (E.G., KINKS) PRIOR TO RETURN? (IF YES, PLEASE SPECIFY WHAT ADDITIONAL DEFECT(S) WERE OBSERVED AND WHERE ON THE DEVICE THIS WAS OBSERVED) ANS: NOT NOTICED. 7. IF ADDITIONAL INTERVENTION WAS PERFORMED, WAS IT DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? ANS: SAME PROCEDURE. 8. 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?) ANS

  Patient problems: Foreign Body In Patient

  MAUDE report 24714225 ↗
• InjuryMay 14, 2025Break; Break

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE ZILVER 635 BILIARY SELF EXPANDING METAL STENT, G50624, WAS USED. WHILE CUSTOMER WAS DEPLOYING THE STENT WHEN THEY GOT TO THE END OF THE STENT DEPLOYMENT, THEY HEARD A POP. THE STENT HAD DEPLOYED; HOWEVER, THE OUTER CATHETER HAD BROKEN OFF AND WAS HANGING OUTSIDE THE PAPILLA STILL. THE CUSTOMER HAD TO USE A RAT TOOTH FORCEPS TO REMOVE THE OUTER CATHETER FROM THE PATIENT. PER CIR, THE FOLLOWING TRIAGE QUESTIONS WERE SENT TO THE DISTRICT MANAGER ON 18APR2025, AND REPLY RECEIVED ON 21APR2025. WHAT WAS THE TARGET LOCATION OF THE STENT? THE RIGHT HEPTIC DUCT. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER)? .035, JAGWIRE. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? (IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE (E.G., CHOLODOCHOJEJUNOSTOMY) NO. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM (E.G., KINKS) PRIOR TO RETURN? (IF YES, PLEASE SPECIFY WHAT ADDITIONAL DEFECT(S) WERE OBSERVED AND WHERE ON THE DEVICE THIS WAS OBSERVED) NO. WHAT WAS THE POSITION OF THE ELEVATOR DURING DEPLOYMENT? ELEVATO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018848 ↗
• InjuryMay 9, 2025Break; Break

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 30 MAY 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992671 ↗
• MalfunctionMar 17, 2025Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  THE STENT DID NOT COME OUT OF THE CATHETER PROPERLY, HENCE COULD NOT BE DEPLOYED. WHAT WAS THE TARGET LOCATION OF THE STENT? BILIARY DUCT DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER)? VIZIGLIDE 0.025 INCH DID THE PATIENT EXHIBIT DIFFICULT ANATOMY? 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, NO COMPLETED IN THE SAME DAY. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? NO IF RESISTANCE WAS FELT HOW DID THE PHYSICIAN DEAL WITH THE RESISTANCE ENCOUNTERED? N/A WAS A STENT PREVIOUSLY PLACED AT THE SAME OR ADJACENT LOCATION? SAME LOCATION. WAS THE STENT BEING PLACED THROUGH THE SIDE WALL OF A PREVIOUSLY PLACED STENT? NO THE COMPLAINT DESCRIPTION STATES THAT THE STENT COULD NOT BE DEPLOYED. WHAT ACTION WAS TAKEN BY THE PHYSICIAN AFTER THIS ISSUE WAS ENCOUNTERED? THE COMPLIANT STENT WAS DISCARDED & THE PROCEDURE WAS COMPLETED WITH A COMPETITOR STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621743 ↗
• MalfunctionJan 23, 2025Break; Activation Failure; Break; Activation Failure

  SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE COMPLETION OF THE INVESTIGATION ON 25 JUN 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217062 ↗
• InjuryDec 17, 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 10 JAN 2025.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20950270 ↗
• InjuryDec 17, 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 10 JAN 2025.

  Patient problems: Abdominal Pain; Itching Sensation; Obstruction/Occlusion

  MAUDE report 20950207 ↗
• MalfunctionDec 11, 2024Break; Activation Failure; Break; Activation Failure

  DURING PROCEDURE, STENT DELIVERY SYSTEM WAS INSERT IN CBD BUT AFTER REMOVE SAFETY LOCK, WHENEVER DEPLOYMENT STARTED ITS NOT DEPLOYED. FEELING TOUGH RESISTANCE DURING DEPOLOYMENT. AFTER THAT REMOVE ALL THE DELIVERY SYSTEM AND USED ANOTHER STENT AND COMPLETED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20910071 ↗
• InjuryNov 28, 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 06-DEC-2024.

  Patient problems: Abdominal Pain; Itching Sensation; Obstruction/Occlusion

  MAUDE report 20804762 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 06-DEC-2024.

  Patient problems: Abdominal Pain; Itching Sensation; Obstruction/Occlusion

  MAUDE report 20795310 ↗
• MalfunctionSep 18, 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 04-OCT-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244648 ↗
• MalfunctionSep 2, 2024Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE COMPLETION OF THE INVESTIGATION ON 14-MAY-2025 AS THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT. "NO ADVERSE EFFECT 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)¿ 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." DEPLOYMENT FORCE IS TOO HIGH; USER CANNOT PULL BACK THE HANDLE TOWARDS THE HUB TO DEPLOY THE STENT. 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. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20117915 ↗
• MalfunctionAug 21, 2024Break; Activation Failure; Break; Activation Failure

  SUPPLEMENTAL REPORT SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON 05-JUN-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018199 ↗
• InjuryMar 14, 2024Break; Activation Failure; Break; Activation Failure

  ACCORDING TO DR. (B)(6), DURING THE DEPLOYMENT OF SEMS, AS SOON AS 2 CM OF THE STENT WAS DELIVERED, IT GOT STUCK AND WHEN AN ATTEMPT WAS MADE TO REMOVE THE DELIVERY SYSTEM, THE STENT BROKE. THE BROKEN STENT WAS REMOVED WITH THE HELP OF FORCEPS AND THE CASE WAS COMPLETED USING ANOTHER STENT. AS PER HOSPITAL NORM DELIVERY SYSTEM AND RUPTURED STENT WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18901620 ↗
• MalfunctionJan 16, 2024Improper or Incorrect Procedure or Method; Dent in Material; Improper or Incorrect Procedure or Method; Dent in Material

  THE OUTER SHEATH GOT STUCK AND STENT DID NOT COME OUT. PATIENT/EVENT INFO - NOTES: QUERY REPLY : 1. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO 2. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? STENT 3. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)?............ WRONG QUESTION . ACCESS SHEATH IS A PRODUCT OF UROLOGY¿.. 4. WHAT WAS THE TARGET LOCATION FOR THE STENT? BILIARY DUCT.. 5. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? NO 6. WAS THE DEVICE USED PERCUTANEOUSLY? NO 7. WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? YES 8. WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? YES 9. WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? N/A 10. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? METII-35-480 ¿ TRACER METRO GUIDE WIRE. 11. DID THE PATIENT EXHIBIT DIFFICULT OR ALTERED ANATOMY (IF ALTERED PLEASE SPECIFY HOW IT IS ALTERED)? N/A 12. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? NO 13. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? NO 14. HOW DID THE PHYSICIAN DEAL WITH THIS RESISTANCE? N/A 15. WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516365 ↗
• InjuryJan 10, 2024Fracture; Mechanical Problem; Fracture; Mechanical Problem

  AS PER PHYSICIAN DURING DEPLOYMENT IT'S GOT STUCK AND OUTER SHEATH NOT COME OUT AFTER APPLYING FORCE ITS GOT BREAK AND HALF OF THE STENT REMAIN INSIDE THE CATHETER AND AFTER THAT DEPLOYMENT HALF BROKEN STENT REMOVED BY FORCEP AND USING ANOTHER STENT AND CASE COMPLETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18483659 ↗
• MalfunctionOct 27, 2023Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 26-JUN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021676 ↗
• MalfunctionSep 26, 2023Activation, 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 ON 01-MAY-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17815622 ↗
• MalfunctionJun 28, 2023Premature Activation; Device Damaged Prior to Use; Premature Activation; Device Damaged Prior to Use

  SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 12-OCT-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216669 ↗
• MalfunctionJun 2, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 19-SEP-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048944 ↗
• MalfunctionApr 13, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE STENT COULDN'T BE SEPARATED FROM CARRIER. "AS PER CC FORM": THE STENT COULD NOT BE RELEASED . ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? UNPACKING OR PREPARATION, INSERTION, DURING STENT PLACEMENT, REMOVING THE INTRODUCER POST STENT PLACEMENT: DURING STENT PLACEMENT. WAS A SPHINCTEROTOMY PERFORMED PRIOR TO USE OF THE STENT DEVICE? YES. WAS BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT DEVICE? NO. WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? LENGTH WAS 5CM , DIAMETER 7MM. WHAT BRAND OF ENDOSCOPE WAS USED WITH THE DEVICE? OLYMPUS GIF-190-VR. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? NO. WHAT WAS THE POSITION OF THE ELEVATOR DURING DEPLOYMENT? N/A. WAS THE DELIVERY SYSTEM TRACKED AROUND A TIGHT ANGLE IN THE PATIENT ANATOMY OR AROUND A TIGHT ANGLE IN AN ENDOSCOPE? NO. WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? YES. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHYLLIC)? 0,25 FROM BOSTON JAG WIRE . WHAT WAS THE TARGET LOCATION FOR THE STENT? WAS THE RED SAFETY LOCK REMOVED BEFORE INSERTING THE DELIVERY SYSTEM? N/A, YES, NO. WAS THE RED SAFET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731541 ↗
• MalfunctionJan 20, 2023Structural Problem; Activation, Positioning or Separation Problem; Structural Problem; Activation, Positioning or Separation Problem

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF IMAGE REVIEW ON 17-FEB-2023: IMPRESSION: THE COMPLAINT OF A ZILBS-635-10-8 DEPLOYED TO A LENGTH OF 4CM IS CONFIRMED. THE INCREASED STENT DENSITY IS CONSISTENT WITH A CONCERTINAED STENT. NO CONCLUSION CONCERNING WHY THE STENT CONCERTINAED CAN BE MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 16213511 ↗
• MalfunctionAug 3, 2022Break; Off-Label Use; Improper or Incorrect Procedure or Method; Break; Off-Label Use; Improper or Incorrect Procedure or Method

  WHILE THE USER ATTEMPTED TO DEPLOY STENT IN THE RIGHT POSTERIOR OF THE HEPATIC "POTAL" LEGION (HILAR) BY USING STENT-IN-STENT METHOD, THE SHEATH BROKE. HE REPLACED IT WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. 1 GENERAL QUESTIONS FOR ALL COMPLAINTS 1-1 (IF ANY DAMAGES WERE CONFIRMED PRIOR TO USE)WAS THE PACKAGE DAMAGED? N.I 1-2 (IF ANY DAMAGES WERE CONFIRMED PRIOR TO USE)HOW WAS THE DEVICE STORED? NI. 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? OLYMPUS. MODEL UNKNOWN. 1-6 WHAT WAS THE TARGET LOCATION FOR THE COMPLAINT DEVICE? RIGHT POSTERIOR. 1-7 WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? YES. 1-8 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHYLIC)? PIOLAX WRANGLER 0.035 INCH. 1-9 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE OR DELIVERY SYSTEM TO THE TARGET LOCATION? YES. 1-10 HOW DID THE PHYSICIAN DEAL WITH THIS RESISTANCE? NI. 1-11 WAS THE PATIENT'S ANATOMY TORTUOUS? NI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15155631 ↗
• MalfunctionFeb 1, 2022Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  REPORTED BY THE DM VIA EMAIL ON BEHALF OF THE CUSTOMER - THE STENT SHEATH SEPARATED AND THE STENT WAS NOT ABLE TO BE DEPLOYED. THE FOLLOWING HAS BEEN REQUESTED- JM 10JAN2022. THE FOLLOWING HAS BEEN ANSWERED- JM 12JAN2022. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. 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. 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 PROVIDE DETAILS. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE THIS OCCURRENCE? NO. THE FOLLOWING HAS BEEN REQUESTED- JM 10JAN2022. THE FOLLOWING HAS BEEN ANSWERED- JM 10JAN2022. PLEASE PROVIDE A CUSTOMER CONTACT PERSON INCLUDING THEIR NAME, TITLE AND CONTACT INFORMATION: (B)(6). WILL THIS BE REPORTED TO THE FDA? NO. WOULD THE CUSTOMER LIKE AN ACKNOWLEDGMENT LETTER? YES. PLEASE CHOOSE AN APPROPRIATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415063 ↗
• MalfunctionJan 17, 2022Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  DISTAL CBD STRICTURE AFTER CANNULATION MILD SPHINCTEROTOMY AND DILATION THE CBD WITH 9FRSBDC, ZILBS-635-10-8 TRIED TO DEPLOYED STENT GONE INSIDE BUT FEEL RESISTANCE WHILE DEPLOYED WITHOUT GIVEN MORE PRESSURE TAKEN OUT THE STENT, SEEN 2-3 GAGES OF THE STENT NEVER OPENED. FINISHED THE CASE BY DEPLOYING ANOTHER ZILVER BILIARY METAL STENT - ZILBS-635-10-8.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266322 ↗