Zilver 635 G50618Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002506180), received between Jan 19, 2017 and Jan 19, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO UPDATES TO THE DESCRIPTION OF EVENTS AND LAB EVALUATION NOTES ON 19-APR-2023THE STENT DELIVERY WAS ADVANCED INTO THE BILIARY TRACT VIA A DUODENAL PAPILLA APPROACH AND WAS POSITIONED AT THE TARGET SITE.WHEN THE USER RELEASED THE STENT, THE DELIVERY SHAFT CAME OFF THE HANDLE WITHOUT ANY RESISTANCE .THE STENT WAS NOT DEPLOYED AT ALL AND WAS RETRIEVED INTACT.THE USER WANTED TO USE ZILBS-635-10-4 10MM X 4CM, HOWEVER THERE WAS NO SPARE IN THE HOSPITAL INVENTORY, SO 10MM X 6CM WAS USED INSTEAD TO COMPLETE THE PROCEDURE.DESCRIPTION OF EVENT HAS BEEN REVISED BY SALE'S REP AS FOLLOWS ON 11/JAN/2023:THE STENT DELIVERY WAS ADVANCED INTO THE BILIARY TRACT VIA A DUODENAL PAPILLA APPROACH AND WAS POSITIONED AT THE TARGET SITE.WHEN THE USER TRIED TO RELEASE THE STENT, THE SHEATH WAS DISCONNECTED AT THE POINT WHERE THE COLOR CHANGED WHITE WITHOUT ANY RESISTANCE .THE STENT WAS NOT DEPLOYED AT ALL AND WAS RETRIEVED INTACT.THE USER WANTED TO USE ZILBS-635-10-4 10MM X 4CM, HOWEVER THERE WAS NO SPARE IN THE HOSPITAL INVENTORY, SO 10MM X 6CM WAS USED INSTEAD TO COMPLETE THE PROCEDURE.NOTE: USER ERROR INCORRECT SIZE 0.025IN WIREGUIDE USED BOTH FO

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

  MAUDE report 16205728 ↗
• MalfunctionJul 16, 2020Fracture; Improper or Incorrect Procedure or Method; Material Deformation; Fracture; Improper or Incorrect Procedure or Method; 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 10281733 ↗
• MalfunctionMar 23, 2017Premature Activation; Premature Activation

  THE DEVICE WAS USED FOR EUS-GUIDED ANTEGRADE STENTING. WHEN ADVANCING THE DELIVERY SYSTEM, THE PHYSICIAN NOTED THAT THE STENT STARTED DEPLOYMENT BEFORE PASSING THROUGH THE STENOSED SITE ALTHOUGH THE RED SAFETY LOCK WAS STILL IN PLACE. THEN, THE DEVICE WITH THE STENT PARTIALLY DEPLOYED WAS REMOVED FROM THE PATIENT. ANOTHER MANUFACTURER'S DEVICE WAS USED INSTEAD AFTER THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6428245 ↗
• MalfunctionMar 1, 2017Premature Activation; Premature Activation

  THE PATIENT HAD PREVIOUSLY HAD RECONSTRUCTION(ROUX-EN-Y) AFTER GASTRECTOMY AND THE DOCTOR SELECTED ZILVER 635 BILIARY SELF EXPANDING METAL STENT TO TREAT HIS MALIGNANT STRICTURE OF THE INTRAHEPATIC BILE DUCT. EST WAS NOT PERFORMED. ZILBS-635-8-4 WAS INSERTED AND ADVANCED TO THE TARGET SITE USING A DOUBLE BALLOON ENDOSCOPE (FUJI FILM'S EI-530B). HOWEVER THE ANATOMY WAS SEVERE AS THE SCOPE POSITION WAS AS 'LOOPED' AND THE ADVANCING THE DELIVERY SYSTEM WAS DIFFICULT WITH STRONG RESISTANCE. THE USER SAW ONLY THE INNER CATHETER WAS ADVANCED FROM THE SHEATH, SO HE DECIDED NOT TO CONTINUE TO USE THIS DEVICE. HE REMOVED THE DELIVERY SYSTEM AND REPLACED IT WITH ZILBS-635-10-4, BUT HE EXPERIENCED THE SAME DIFFICULTY. HE DISCONTINUED THE PROCEDURE WITHOUT PLACING ANY STENTS AND PLANNED PLACING STENTS PERCUTANEOUSLY FOR THE NEXT TIME. WHEN WASHING THE ENDOSCOPE AFTER THE PROCEDURE, A STENT WAS FOUND IN THE SCOPE CHANNEL. THE USER WAS NOT SURE WHEN IT WAS DEPLOYED FROM THE DELIVERY SYSTEM OR IF IT WAS FROM 8-4 OR 10-4, BUT THEY DISCARDED BOTH DEVICES INCLUDING THIS DEPLOYED STENT. THE RED SAFETY TAB WAS NOT REMOVED. AS THERE ARE TWO SUSPECTED DEVICES INVOLVED IN THIS EVENT A SEPARATE REPORT HAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6367567 ↗
• MalfunctionJan 19, 2017Premature Activation; Premature Activation

  A FOLLOW-UP MDR IS BEING SUBMITTED TO INCLUDE THE DEVICE EVALUATION DETAILS. INITIAL REPORT DETAILS: METALIC STENTS HAD BEEN PLACED IN THE RIGHT AND LEFT HEPATIC DUCTS WITH SIDE-BY-SIDE TECHNIQUE BEFORE. THE ZILBS- STENT WAS TO BE ADDITIONALLY PLACED IN THE RIGHT HEPATIC DUCT AS REINTERVENTION. DURING ADVANCEMENT OF THE DELIVERY SYSTEM, THE STENT WAS PARTIALLY DEPLOYED. THEREFORE, THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS FINISHED WITHOUT ANY FURTHER TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6263432 ↗