Zilver PTX G38486Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002384863), received between Aug 22, 2017 and Feb 26, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Delivery System Failure” (1 report).

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.

• MalfunctionFeb 26, 2020Expiration Date Error; Expiration Date Error

  EXPIRED ZILVER PTX PLACED IN PATIENT. NO ISSUES DURING THE PROCEDURE. NO ADVERSE EFFECTS REPORTED. NO ADDITIONAL INTERVENTIONS NEEDED. THE PHYSICIAN PUT THE PATIENTS ON ANTIBIOTICS AFTER THE CASE BECAUSE HE WAS WORRIED ABOUT THE STERILITY OF THE STENT. PATIENT HAD NO ISSUES AT TIME OF/IMMEDIATELY AFTER PROCEDURE. FACILITY WILL NOT BE REPORTING TO THE FDA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9755900 ↗
• MalfunctionJul 26, 2019Fracture; Fracture

  AS REPORTED TO CUSTOMER RELATIONS, "UPON DEPLOYING THE STENT AND WITHDRAWING THE DELIVERY SYSTEM FROM THE SHEATH, RESISTANCE WAS MET AND THE DISTAL END OF THE STENT DELIVERY SYSTEM APPEARED TO BREAK OFF."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8829801 ↗
• MalfunctionApr 2, 2019Use of Device Problem; Use of Device Problem

  AS REPORTED TO CUSTOMER RELATIONS: "PHYSICIAN SAID HE STARTED ADVANCING THE ZILVER PTX OVER THE BENTSON WIRE AND FELT RESISTANCE AS IT WAS GOING OVER THE WIRE AND THRU THE SHEATH. HE SAID HE GOT IT ABOUT 4-5 CM BEFORE WHERE HE NEEDED TO DEPLOY THE STENT AND IT WOULDN'T ADVANCE ANY FURTHER. HE TRIED REMOVING IT AND WAS HAVING A DIFFICULT TIME. HE FINALLY PULLED THE ZILVER PTX DELIVERY CATHETER ALONG WITH THE BENTSON WIRE OUT OF THE PATIENT. HE LOST ACCESS, BUT GOT THE WIRE BACK TO THE CELIAC AND OPENED ANOTHER 7X40 ZILVER PTX. THAT ONE DEPLOYED WITHOUT AND COMPLICATIONS AND THERE WAS NO RESISTANCE GOING OVER THE WIRE. THE PATIENT WAS NOT HARMED DURING THIS PROCEDURE." ADDITIONAL INFORMATION PROVIDED BY CUSTOMER OVER THE PHONE ON 02APR2019: "IMAGERY WILL NOT BE MADE AVAILABLE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8474337 ↗
• MalfunctionMar 20, 2018Delivery System Failure; Delivery System Failure

  INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT¿". AS REPORTED TO CUSTOMER RELATIONS, "THE THUMBWHEEL STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7352850 ↗
• MalfunctionAug 22, 2017Difficult to Remove; Difficult to Remove

  THIS INITIAL REPORT IS BEING SUBMITTED DUE TO THE MALFUNCTION PRECEDENCE: "DELIVERY SYSTEM CANNOT BE WITHDRAWN". THIS REPORT FORMS PART OF RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOR A NEW MALFUNCTION PRECEDENCE FOR THIS DEVICE FAMILY. BALKIN SHEATH WAS UP AN OVER THE AORTIC BIFURCATION, STIFF .035 WIRE WAS DOWN THE CONTRA-LATERAL SFA, PRE-DIL OCCURRED AND PHYSICIAN DECIDED TO PLACE STENT. STENT WAS DIFFICULT TO TRACK TO LESION, DEPLOYED FINE, AND COULD NOT BE REMOVED SO WIRE AND CATHETER HAD TO BE REMOVED TOGETHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6810634 ↗