Zilver PTX G38463Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10827002384634), received between Sep 5, 2016 and Oct 17, 2022 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2022Failure to Advance; Activation, Positioning or Separation Problem; Failure to Advance; Activation, Positioning or Separation Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 06-FEB-23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615204 ↗
• MalfunctionNov 10, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT BEING SUBMITTED FOR LAB EVALUATION COMPLETED ON 05-NOV-21: LAB EVALUATION COMPLETED ON 05-NOV-21: DISTAL WHITE TIP SLIGHT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787861 ↗
• InjuryNov 26, 2019Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA PHONE DISCUSSION & SUBMITTED EMAIL FROM DISTRICT MANAGER PER THE CUSTOMER: PATIENT WAS IN INTERVENTIONAL RADIOLOGY FOR IR THROMBOLYSIS THERAPY AND ANGIOGRAM. DURING THE PROCEDURE A ZILVER PTX 6MMX 40MM STENT WAS USED AND IT PREMATURELY DEPLOYED. WHILE THIS STENT WAS BRING RETRACTED, USING THE FILTER AND THE FILTER WIRE, PART OF THE STENT SHEARED OFF NEAR THE LEFT COMMON FEMORAL ARTERY ACCESS SITE. CT WAS ORDERED TO DETERMINE EXACT LOCATION OF SHEARED OFF SITE. PER CT: NO DEFINITE INTRAVASCULAR FOREIGN BODY IS VISUALIZED. QUESTIONABLE HYPERDENSE FRACTURED STENT MATERIAL SURROUNDING THE SHEATH. SENT DESCRIBED ABOUT HAS BEEN SAVED. PATIENT WAS SUBSEQUENTLY TRANSFERRED TO SUMMIT IN THE EVENT FURTHER INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION PROVIDED 07NOV2019: PATIENT WAS IN THE HOSPITAL PREVIOUSLY RECEIVING THROMBOLYSIS FOR SEVERE CLOTS. PATIENT HAD PREVIOUS STENTS THAT WERE TOTALLY OCCLUDED. THEY HAD A 6X45 ANSEL SHEATH AND A .018 SPIDER FILTER WIRE THAT WAS PLACED BELOW THE KNEE. PHYSICIAN DID A PRE-ANGIOPLASTY AT THE TARGET LOCATION. THEY THEN ADVANCED A COOK BENTSON .035 WIRE DOWN AND THEN TRACKED THE ZILVER PTX DELIVERY CATH

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9374602 ↗
• InjuryNov 4, 2019Fracture; Fracture

  ACCORDING TO THE INITIAL REPORTER, PATIENT WAS IN INTERVENTIONAL RADIOLOGY FOR IR THROMBOLYSIS THERAPY AND ANGIOGRAM. DURING THE PROCEDURE A ZILVER PTX 6MMX 40MM STENT WAS USED AND IT PREMATURELY DEPLOYED. WHILE THIS STENT WAS BRING RETRACTED, USING THE FILTER AND THE FILTER WIRE, PART OF THE STENT SHEARED OFF NEAR THE LEFT COMMON FEMORAL ARTERY ACCESS SITE. CT WAS ORDERED TO DETERMINE EXACT LOCATION OF SHEARED OFF SITE. PER CT: NO DEFINITE INTRAVASCULAR FOREIGN BODY IS VISUALIZED. QUESTIONABLE HYPERDENSE FRACTURED STENT MATERIAL SURROUNDING THE SHEATH. PATIENT WAS SUBSEQUENTLY TRANSFERRED TO (B)(6) (ACCOUNT (B)(6) ) IN THE EVENT FURTHER INTERVENTION WAS REQUIRED.

  Patient problems: No Code Available

  MAUDE report 9273979 ↗
• MalfunctionApr 10, 2018Premature Activation; Premature Activation

  THIS FOLLOW UP REPORT IS BEING SUBMITTED TO UPDATED THE INVESTIGATION RESULTS. INITIAL MDR SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿PREMATURE STENT DEPLOYMENT WITH SAFETY LOCK IN PLACE". DURING DEVICE PREP AS THE STENT WENT OVER THE WIRE AFTER BEING FLUSH AND DISTAL EDGE OF THE STENT WAS EXPOSED. A NEW DEVICE WAS OPENED FOR THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7412376 ↗
• MalfunctionNov 3, 2017Delivery System Failure; Activation, Positioning or Separation Problem; Delivery System Failure; Activation, Positioning or Separation Problem

  THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM THE FDA THAT THE DEVICE HAS BEEN RETURNED AND INVESTIGATION CONCLUSIONS ARE PENDING. A FOLLOW UP WILL BE SUBMITTED IN 30 DAYS WITH THE INVESTIGATION CONCLUSIONS. INITIAL REPORT DETAILS; MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE 'THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT''. AS REPORTED TO CUSTOMER RELATIONS, "THE STENT WAS ABOUT 20% DEPLOYED OR ABOUT 3 TO 4 CELLS AND THE WHEEL ON THE HANDLE STOPPED RETRACTING THE SHEATH. IT WAS NOT UNSHEATHING THE STENT." THE RIGHT ILIAC ABBOT STENT THROMBOSED OFF AND THE SFA STENTS DID NOT. THE PATIENT WAS LOADED WITH 300 MILLIGRAMS OF PLAVIX. EVENT DESCRIPTION / UPDATED INFO PROVIDED BY DM ON 11OCT2017: "ACCESS WAS GAINED IN LEFT GROIN FOR A RLE INTERVENTION. MICROPUNCTURE WAS USED FOR ACCESS. BENTSON WIRE INSERTED THROUGH MPIS, SWAPPED OUT FOR 5FR SHEATH. DIAGNOSTIC CATH INSERTED OVER THE WIRE INTO DISTAL AORTA. WIRE REMOVED AND AORTOGRAM PERFORM. KISSING ILIAC STENTS (ABBOTT OMNILINK) CONFIRMED AT THE BIFURCATION. WIRE ADVANCED CONTRATERALLY TO LESION IN MID SFA. CATHETER ADVANCED. WIRE SWAPPED OUT FOR STIFFER WIRE. CATHETER AND 5FR SHEATH REMOVED. 6FR ANSEL INSERTED AND

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6999312 ↗
• MalfunctionMar 27, 2017Shelf Life Exceeded; Shelf Life Exceeded

  REP STOCK OF STENTS WERE LEFT AT THE FACILITY FOR A PROCEDURE. AT THIS TIME, NONE OF THE STENTS WERE EXPIRED. THE REP COULD NOT ATTEND THE PROCEDURE. ONE OF THE STENTS EXPIRED BEFORE THE PROCEDURE OCCURRED AND WAS USED FOR THE PROCEDURE. THE NURSE DID NOT REALIZE THAT THE PRODUCT WAS EXPIRED. IT WAS IMPLANTED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6435609 ↗
• MalfunctionSep 5, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PHYSICIAN ACCESSED LEFT SIDE ANTIGRADE LEFT COMMON FEMORAL ARTERY TO TREAT THE PROXIMAL LEFT FSA. ON DEPLOYMENT THE ZILVER PTX STENT SHORTENED TO HALF THE SIZE. A SECOND STENT WAS USED TO BRIDGE THE GAP. NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5927611 ↗