Zilver G25731Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10827002257310), received between Jul 11, 2016 and Apr 21, 2021 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2021Unintended Ejection; Malposition of Device; Unintended Ejection; Malposition of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. THE PHYSICIAN NOTICED THAT SOME PORTION OF THE STENT WAS OUTSIDE FROM THE CATHETER [PREMATURE STENT DEPLOYMENT] AS SOON AS THE INTRODUCER SYSTEM OF THE ZILVER'S CATHETER CAME OUT FROM THE ACCESSORY CHANNEL OF THE ENDOSCOPE [SUBJECT OF REPORT]. THE PHYSICIAN WAS NOT ABLE TO INTRODUCE THE STENT IN THE PAPILLA. 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 problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703590 ↗
• InjuryNov 8, 2019Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. THE STENT COULD NOT BE DEPLOYED AND GOT STUCK. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 15- OCT-2019: A SECTION OF THE DEVICE DETACHED INSIDE THE PATIENT AND THE PATIENT WAS SENT FOR SURGERY. THE FOLLOWING ADDITIONAL CLARIFICATION WAS RECEIVED ON 17- OCT-2019: AS PER THE PHYSICIAN, WHILE FOLLOWING THE DEPLOYMENT STEPS DURING THE PROCEDURE, THE STENT DID NOT OPEN FULLY AND HENCE WAS NOT ABLE TO DEPLOY IN THE DESIRED PLACE. DURING THAT TIME THE STENT AND CATHETER GOT STUCK INSIDE THE DUCT AND COULD NOT BE PULLED BACK. THE SHEATH GOT DETACHED AND WAS LEFT INSIDE AS THE NURSE WAS TRYING TO BRING IT OUT. THE PATIENT WAS ALREADY COMPROMISED DUE TO HYPERBILIRUBINEMIA STATE, HENCE INSTEAD OF DOING A BILIARY BYPASS SURGERY THE PHYSICIAN THOUGHT OF PUTTING A BILIARY STENT. BUT AS THE STENTING GOT STUCK, THE PATIENT HAD TO UNDERGO SURGERY. THE STENT BECAME STUCK INSIDE THE PATIENT AND PART OF THE DEVICE DETACHED INSIDE THE PATIENT. AS A RESULT, THE PATIENT WAS SENT TO SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9298827 ↗
• MalfunctionSep 19, 2019Premature Activation; Premature Activation

  DURING A STENT PLACEMENT PROCEDURE, THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. WHILE THE STENT WAS PASSING THROUGH THE ENDOSCOPE WORKING CHANNEL, PARTIAL STENT GOT OPEN [STENT PARTIALLY DEPLOYED]. THE PHYSICIAN NOTICED THIS AND TOOK OUT THE ENTIRE SYSTEM AND DEPLOYED THE STENT OUT SIDE THE PATIENT AND REMOVED THE DELIVERY SYSTEM. THE PHOTO PROVIDED DEPICTS THE STENT DEPLOYED AND STILL ATTACHED TO DEPLOYMENT DEVICE. THE STYLET HAS BEEN REINSERTED. 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 problems: No Consequences Or Impact To Patient

  MAUDE report 9088547 ↗
• InjuryMay 20, 2019Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  DURING A STENT PLACEMENT PROCEDURE, THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. THE PHYSICIAN PULLED THE INTRODUCER BACK TOO SOON AND CAUGHT THE INTRODUCER ON THE STENT. THE LIP OF THE INTRODUCER SNAGGED IN THE STENT AND IT [THE TIP OF THE INTRODUCER] SEPARATED. THE PATIENT WAS SENT TO RADIOLOGY TO HAVE THE DEVICE PORTION REMOVED. THE REMOVAL OF THE DEVICE PORTION WAS SUCCESSFUL. THE OVERALL OUTCOME OF THE PROCEDURES WAS SUCCESSFUL AND THE PATIENT IS DOING WELL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED THE DETACHED PORTION OF THE DEVICE TO BE REMOVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8623441 ↗
• MalfunctionFeb 1, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) STENT IMPLANTATION PROCEDURE, THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. THE DEVICE WAS ADVANCED TO THE DESIRED POSITION (HEPATIC DUCT) ALONG THE WIRE GUIDE. THE USER AND THE NURSE WORKED TOGETHER TO RELEASE THE STENT, BUT FELT OBVIOUS RESISTANCE AFTER RELEASING THE STENT AROUND ONE (1) CM [PARTIALLY DEPLOYED]. THE USER DECIDED TO WITHDRAW THE DEVICE AND ENDOSCOPE FROM THE PATIENT, RELEASE THE STENT, THEN PULL OUT THE OUTER SHEATH. THE USER PUT THE ENDOSCOPE BACK INTO THE PATIENT ALONG THE WIRE GUIDE AND USED ANOTHER OF THE SAME DEVICE TO CONTINUE AND 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8297279 ↗
• MalfunctionDec 3, 2018Fracture; Fracture

  DURING A METAL STENT IMPLANTATION, THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. THE STENT WAS IMPLANTED. THE USER INTRODUCED THE STENT WITHOUT ANY PROBLEMS, BUT THERE WAS A RESISTANCE WHEN PULLING BACK THE INTRODUCTION SYSTEM. THE RESISTANCE WAS OVERCOME AND THE INTRODUCER WAS TAKEN OUT. ON THE X-RAY TAKEN AFTER THE PROCEDURE, THE STENT LOOKED LIKE IT WAS BROKEN ABOUT ONE (1) CM FROM THE DISTAL END. NO FURTHER ACTION OR PROCEDURES WERE DONE. OTHER THAN THE DEPLOYED STENT, 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 problems: No Consequences Or Impact To Patient

  MAUDE report 8124216 ↗
• MalfunctionNov 14, 2018Break; Use of Device Problem; Break; Use of Device Problem

  DURING A METAL STENT PLACEMENT PROCEDURE, THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. THE STENT WAS INITIALLY PLACED TOO FAR DOWN. ON THE ATTEMPT TO REPOSITION THE ZILVER STENT [USE ERROR], PART OF IT TORE OFF. THE OTHER PART REMAINED IN THE PATIENT. THE FOLLOWING ACTION WAS TO PLACE [ANOTHER, NEW] STENT IN [THE EXISTING PARTIAL] STENT. A PORTION OF THE ORIGINALLY DEPLOYED STENT REMAINED INSIDE THE PATIENT¿S BODY AS INTENDED. 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 problems: No Consequences Or Impact To Patient

  MAUDE report 8068675 ↗
• MalfunctionMar 9, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. THE STENT WOULD NOT DEPLOY. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 02/13/2018. IT WAS DETERMINED THAT THE STENT DEPLOYED 1.8 CM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7327040 ↗
• MalfunctionSep 27, 2017Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. AS REPORTED TO CUSTOMER RELATIONS: ¿THE PATIENT HAD METASTATIC COLON CANCER AND A BILIARY STRICTURE AT THE HILUM OF THE LIVER INTO THE LEFT INTRA HEPATIC DUCTS. THE PHYSICIAN WAS USING AN (B)(4) ERCP ENDOSCOPE 180 AND USED A .021 [INCH WIRE GUIDE] TO DO A SPHINCTEROTOMY AND GAIN ACCESS INTO THE BILE DUCT. A COOK TRI-EX EXTRACTION BALLOON AND A COOK TRACER HYBRID WIRE GUIDE (ANGLED) WAS USED TO GAIN ACCESS INTO THE LEFT SYSTEM. A TIGHT STRICTURE WAS SEEN WHICH WAS ANGULATED AND A ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM WAS PLACED OVER THE GUIDE WIRE AND SUCCESSFULLY DEPLOYED. THERE WAS A TIGHT WAIST ON THE STENT AFTER DEPLOYMENT. THE DIFFICULTY OCCURRED WHEN TRYING TO REMOVE THE DELIVERY SYSTEM. THE TIP OF THE INTRODUCER GOT CAUGHT IN THE STENT WHERE IT IS NARROW AND TAKES A TURN. THE PHYSICIAN PULLED HARDER AND THE INTRODUCER BROKE, LEAVING ABOUT 15 CM IN THE PATIENT WITH THE TIP STILL CONNECTED. THE PATIENT IS GOING TO HOSPICE; NO INTERVENTION WILL BE PERFORMED."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6896865 ↗
• MalfunctionSep 1, 2017Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. THE STENT WAS SUCCESSFULLY DEPLOYED. WHEN THEY PULLED OUT THE DELIVERY SYSTEM, IT BECAME CAUGHT ON THE METAL STENT. THIS WAS IN A TIGHT STRICTURE. THE DISTAL TIP BROKE OFF INTO THE PATIENT'S BODY. IT WAS LEFT TO PASS NATURALLY THROUGH THE STENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6839205 ↗
• MalfunctionDec 16, 2016Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. DURING THE PROCEDURE THE STENT WAS PARTIALLY DEPLOYED AND COULD NOT COME OUT FROM THE CATHETER. THE PROCEDURE WAS FINISHED WITH ANOTHER ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/08/16 STATING THE STENT HAD BEEN PARTIALLY DEPLOYED 1 CM.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6181758 ↗
• InjuryJul 11, 2016Fracture; Fracture

  DURING AN ENDOSCOPIC PROCEDURE THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. THE ZILVER EXPANDABLE METAL BILIARY STENT WAS DEPLOYED SUCCESSFULLY IN THE TARGETED ZONE. WHEN THE PHYSICIAN WENT TO REMOVE THE DELIVERY SYSTEM AND WIRE GUIDE, A PORTION OF THE PROXIMAL END STRUT WAS FRACTURED AND CAME OUT OF THE BILE DUCT. THE FRACTURED PORTION WAS RETRIEVED LEAVING THE REMAINING STENT IN THE CORRECT POSITION.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 5782532 ↗