Zilver 635 G23813Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002238135), received between Nov 14, 2018 and Jun 1, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Off-Label Use; Off-Label Use

  AFTER GASTRECTOMY, THE USER INSERTED ZILBS-635-8-12 FROM A ACCESSORY CHANNEL OF FUJIFILM/SHORT DOUBLE BALLOON ENDOSCOPE EI-580BT, AND PERFORMED ERCP FOR THE POSTOPERATIVE RECONSTRUCTION OF INTESTINAL TRACT. THERE WAS ALSO A TORTUOSITY OF ENDOSCOPE, HE FELT A RESISTANCE BUT COULD ADVANCE ZILBS-635-8-12 TO A TARGET SITE OF INTRAHEPATIC BILE DUCT. HE PULLED THE SHEATH TO DEPLOY THE STENT BUT THE SHEATH SEVERED. HE SELECTED ZILBS-635-8-10 INSTEAD TO COMPLETE PLACEMENT PROCEDURE. THIS FILE WILL CAPTURE THE OFF LABEL PLACEMENT OF THE REPLACEMENT DEVICE IN ALTERED ANATOMY THAT WAS USED TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, NO HEALTH HAZARD. PATIENT/EVENT INFO - NOTES: 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? N/A. 1-3 WAS A SPHINCTEROTOMY OR BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT DEVICE? UNKNOWN. 1-4 WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? NO. 1-5 WHAT BRAND OF ENDOSCOPE WAS USED WITH THE DEVICE? FUJIFILM/EI-580BT. 1-6 WHAT WAS THE TARGET LOCATION FOR THE COMPLAINT D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037300 ↗
• MalfunctionDec 21, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  THE DELIVERY SYSTEM GAVE WAY AND DID NOT DEPLOY. "AS PER CC FORM": THE DELIVERY SYSTEM BROKE DOWN & DID NOT DEPLOY. TRANSLATION: HELLO, THE DIGESTIVE ENDOSCOPY DEPARTMENT DECLARED A MATERIOVIGILANCE INCIDENT DURING THE USE OF A PROSTHESIS REF: ZILBS-635-8-10, LOT C1917552, EXPIRY DATE: 02/25/25. DESCRIPTION OF THE FACTS: THE DELIVERY SYSTEM GAVE WAY AND DID NOT DEPLOY. THE MD HAS BEEN KEPT AND IS AVAILABLE FOR EXPERTISE. PLEASE SEND ME APPROPRIATE TRANSPORT PACKAGING IF YOU WISH TO ANALYZE IT. CAN YOU TELL ME IF YOU HAVE HAD OTHER REPORTS OF THIS TYPE CONCERNING THIS REFERENCE / THIS BATCH NUMBER? OR IF THE ANALYSIS OF THE PRODUCTION BATCH BRINGS OTHER ELEMENTS? THE PROSTHESIS IS ON DEPOSIT WITH US, THE ORDER NUMBER FOR RENEWAL IS: (B)(4), ITS PRICE IS (B)(4). THE MATERIOVIGILANCE NUMBER TO CALL FOR ALL CORRESPONDENCE IS (B)(4). 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. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. 2. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAI

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

  MAUDE report 16023595 ↗
• MalfunctionMay 9, 2022Break; Break

  THE USER ATTEMPTED TO PERFORM SBS TO PLACE THE STENTS IN THE HILAR BILE DUCT. HE ADVANCED TWO DELIVERY SYSTEMS OF ZILBS-635-8-10 AT THE TARGET SITE AND HE PULLED THE HANDLE TO DEPLOY THE STENT IN THE LEFT BILE DUCT FIRST. HOWEVER THE STENT WAS NOT DEPLOYED AT ALL EVEN THE HANDLE WAS COMPLETELY PULLED. THE USER FOUND THE HANDLE AND THE CANNULA WITH THE HUB MOVED FREELY BUT THE STENT WAS STILL NOT DEPLOYED AT ALL. HE GAVE UP ON USING THIS DEVICE FOR SBS AND PLACED ZILBS-635-8-8 AS SIS INSTEAD TO COMPLETE THE PROCEDURE. LAB EVALUATION 03 MAY 2022. VISUAL INSPECTION: RED SAFETY LOCK NOT RETURNED,AND OUTER SHEATH IS SEPARATED APPROX. 28,5CM FROM THE DISTAL END. FUNCTIONAL INSPECTION: DEVICE FLUSHED WITH NO ISSUES, 0.035 INCH WIRE GUIDE PASSED WITH NO ISSUES, AND STENT WOULD NOT DEPLOY FROM THE OUTER SHEATH. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337822 ↗
• MalfunctionJun 9, 2020Use of Device Problem; Use of Device Problem

  WHILE DEPLOYING THE ZILVER STENT IN THE LEFT HEPATIC DUCT, THE PHYSICIAN MENTIONED THAT THE MARKERS UNDER FLUOROSCOPY WERE NOT OBVIOUS AND MAY HAVE CONTRIBUTED TO HIM DEPLOYING THE STENT SLIGHTLY HIGHER THAN ANTICIPATED. HE DOES NOT WANT TO MAKE A COMPLAINT BUT FELT THE LACK OF VISIBILITY OF THE STENT WAS A CONTRIBUTING FACTOR TO THE STENT BEING DEPLOYED TOO HIGH. WHILE DEPLOYING THE ZILVER STENT YESTERDAY, THE PHYSICIAN MENTIONED THAT THE MARKERS UNDER FLUOROSCOPY WERE NOT OBVIOUS AND MAY HAVE CONTRIBUTED TO HIM DEPLOYING THE STENT SLIGHTLY HIGHER THAN ANTICIPATED. ADDITIONAL INFO RECEIVED 12-MAY-2020: THE PHYSICIAN MANAGED TO REPOSITION THE STENT JUST AFTER DEPLOYMENT BY MANIPULATING IN WITH SPYBITE FORCEPS DURING THAT PROCEDURE. ADDITIONAL FILE CREATED TO CAPTURE USER ERROR AS THIS DEVICE SHOULD NOT BE MOVED ONCE PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10131998 ↗
• MalfunctionFeb 26, 2020Off-Label Use; Off-Label Use

  THE CUSTOMER PLANNED TO PLACE A 8MM-12CM STENT IN EACH OF THE RIGHT B5, B6 AND THE LEFT B3 TO THE HEPATIC PORTAL REGION. FIRSTLY, HE REMOVED AN ENBD CATHETER THAT HAD BEEN PLACED IN THE RIGHT B5 AND A ERBD CATHETER THAT HAD BEEN PLACED IN THE LEFT B3. THEN HE CHECKED THE LENGTH OF STENOSED SITE BY ANGIOGRAPHY. THEN HE PLACED GUIDE WIRES IN B5, B6 AND B3. HE THEN PLACED A STENT IN B5 AND B3 SUCCESSFULLY USING SBS TECHNIQUE. HE THEN ADVANCED A WIRE GUIDE TO B6 THROUGH THE MESH OF THE STENT THAT WAS PLACED IN B5 AND ADVANCED THE DELIVERY SYSTEM OF ZILBS-635-8-12(LOT# C1600624) OVER THE WIRE GUIDE. HOWEVER THE DELIVERY SYSTEM WOULD NOT GO THROUGH THE MESH, SO HE REMOVED THE DELIVERY SYSTEM FROM THE ENDOSCOPE TO DILATE THE MESH. HE THOUGHT WHOLE DELIVERY SYSTEM WAS REMOVED BUT FOUND THE TIP WAS SEPARATED FROM THE DELIVERY SYSTEM AND LEFT IN THE ENDOSCOPE TIP. HE REMOVED THE TIP USING GRASPING FORCEPS SUCCESSFULLY. ANOTHER ZILBS-635-8-12(LOT# UNKNOWN) WAS USED INSTEAD AND THE STENT WAS PLACED IN B6 TO COMPLETE THE PROCEDURE. ADDITIONAL EXPLANATION FOR THE DEVICES USED FOR THIS PROCEDURE: (B)(6), (B)(6) 2020 1. ZILBS-635-8-12 (C1519479) WAS PLACED IN B5 USING SBS TECHNIQUE WITH ZILBS-635-

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9755855 ↗
• InjuryDec 24, 2019Fracture; Obstruction of Flow; Material Deformation; Fracture; Obstruction of Flow; Material Deformation

  LHD=LEFT HEPATIC DUCT, RHD=RIGHT HEPATIC DUCT, RPSD=RIGHT POSTERIOR SECTORAL DUCT, RASD=RIGHT ANTERIOR SECTORAL DUCT. THREE ZILVER 635 WERE USED WITH SBS (SIDE-BY-SIDE TECHNIQUE) IN THE FOLLOWING ORDER. THIS PATIENT HAD STENOSIS AROUND BIFURCATION OF LHD AND RHD (ESPECIALLY IN THE ORIGIN OF LHD). 1.TWO DELIVERY SYSTEMS OF ZILVER 635 WERE DELIVERED TO RASD AND RPSD. ZILVER 635 IN RASD WAS DEPLOYED FIRST AND THE DELIVERY SYSTEM WAS REMOVED FROM THE BODY WHILE ANOTHER DELIVERY SYSTEM IN THE RPSD WAS REMAINED THERE. 2.IN ORDER TO PLACE STENTS IN RPSD AND LHD WITH SBS, THE USER ATTEMPTED TO ADVANCE ANOTHER ZILVER 635 DELIVERY SYSTEM TO LHD BUT HE COULD NOT DO THAT. THEREFORE THE DELIVERY SYSTEM IN RPSD AND LHD WERE REMOVED FROM THE BODY AND THE USER PERFORMED BALLOON INFLATION OF RPSD AND LHD WITH KANEKA MEDICS'S BALLOON(REN 4MM). 3.THEN THE USER COULD SOMEHOW DELIVER TWO DELIVERY SYSTEMS IN RPSD AND LHD. 4.THE USER STARTED TO DEPLOY THE STENT (ZILBS-635-8-10/LOT C1552921) IN RPSD. THE USER DID NOT FEEL ANY RESISTANCE DURING THE DEPLOYMENT BUT THE HANDLE SUDDENLY STOPPED MOVING WHEN THE SHEATH TIP REACHED AROUND THE BIFURCATION. THE USER WAS NOT ABLE TO FULLY DEPLOY THE STENT, SO HE HAD

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

  MAUDE report 9516328 ↗
• InjuryNov 14, 2018Fracture; Fracture

  AS REPORTED TO CUSTOMER RELATIONS "DURING DEPLOYMENT OF THE STENT, THEY ATTEMPTED TO REPOSITION THE STENT AND THE STENT ENDED UP SHREDDING INTO MULTIPLE PIECES THAT WERE LEFT BEHIND IN THE BILIARY DUCT. AFTER THAT, THEY HAD TO RETRIEVE THE PIECES. THEY USED BIOPSY FORCEPS, A SNARE AND AN EXTRACTION BALLOON. THEY WERE ABLE TO GET ALL OF THE PIECES OUT. THEY ENDED UP PLACING A BOSTON SCIENTIFIC WALL FLEX UNCOVERED BILIARY STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8068453 ↗