Zilver PTX G38489Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10827002384894), received between May 11, 2017 and Apr 22, 2025 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Delivery System Failure” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE ZILVER PTX STENT (INFO ATTACHED) WASN'T SUCCESSFULLY DEPLOYED. THE PHYSICIAN WAS WANTING TO DEPLOY IT IN THE PROXIMAL SFA WHICH WAS SUPER CALCIFIED, BUT THE STENT WOULDN'T PASS THROUGH THE SHEATH ON THE CONTRALATERAL SIDE. WHEN HE REMOVED THE STENT TO EXAMINE IT, THE DELIVERY CATHETER WAS KINKED. THE PATIENT WASN'T HARMED, AND THE STENT WAS SUCCESSFULLY REMOVED BEFORE IT WAS DEPLOYED. ANOTHER STENT (SAME SIZE AND SAME LOT NUMBER) WAS SUCCESSFULLY PLACED WITH NO ISSUE. ADDITIONAL INFO RECEIVED 03-APR-2025. 1. WAS THE DEVICE FLUSHED BEFORE THE PROCEDURE, AS PER IFU? N/A, YES, NO. -YES IT WAS FLUSHED IT WAS FLUSHED. 2. WERE THERE ANY ISSUES WITH FLUSHING OF THE DEVICE? N/A, YES, NO. -NO ISSUES FLUSHING. 3. DETAILS OF THE ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? -TERUMO 6 FRENCH SHEATH UP AND OVER. 4. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHYLIC)? -.014 GLIDE ADVANTAGE. 5. WAS THE WIRE GUIDE REMOVED FROM THE PATIENT PRIOR TO ADVANCING THE DELIVERY SYSTEM? N/A, YES, NO. -NO, NOT REMOVED. 6. IF REMOVED, WAS THE WIRE GUIDE WIPED PRIOR TO ADVANCEMENT OF THE DELIVERY SYSTEM? N/A, YES, NO, -THE WIRE WAS IN PLACE. 7. WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885524 ↗
• MalfunctionJun 2, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PER MEDWATCH FORM: PATIENT UNDERWENT DIAGNOSTIC ARTERIOGRAM AND TRANSCATHETER INTERVENTION; FIRST STENT WAS DEPLOYED ((B)(4) LOT C1741457), AND MD REQUESTED AN ADDITIONAL STENT. PRIOR TO PLACEMENT, IT WAS DISCOVERED THE DATE ON THE STENT PACKAGING WAS EXPIRED 9-16-2022. ((B)(6) LOT C1769805) DATE OF IMPLANT: (B)(6) 2022. PATIENT OUTCOME: 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? A. IF YES, PLEASE DESCRIBE. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? A. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? 6. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? A. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. PATIENT/EVENT INFO - NOTES: PLEASE PROVIDE THE ORIGINATOR A LIST OF ANY ADDITIONAL MANUFACTURER QUESTIONS REQUIRED FOR INVESTIGATION. SG 08MAY2023 THE FOLLOWING INFORMATION HAS BEEN REQUESTED VIA EMAIL ON 30MAY2023. S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048973 ↗
• MalfunctionAug 4, 2020Failure to Advance; Failure to Advance

  COMPLAINT CALLED IN BY DM ON (B)(6) 2020--DID (B)(6) 2020. AS REPORTED TO CUSTOMER RELATIONS: "DEVICE FAILED TO DEPLOY ON FIRST ATTEMPT, DEPLOYED SUCCESSFULLY ON SECOND ATTEMPT BUT OUTSIDE THE BODY. COMPLETED PROCEDURE WITH ANOTHER OF THE SAME GPN."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10361188 ↗
• MalfunctionMar 6, 2019Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  THERE ARE THREE FILES RELATED TO THIS INCIDENT. THIS FILE WAS CREATED TO CAPTURE THE SECOND DEVICE. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT FRACTURE'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING. AS REPORTED TO CUSTOMER RELATIONS, "PRODUCTS FAILED TO DEPLOY CORRECTLY. DEPLOYMENT ISSUE. COAXIAL SYSTEM DIDN¿T MOVED SEEM VERY TIGHT WHILE SCROLLING BACK. WHILE PULLING FIRST SYSTEM OUT STENT STARTED COMING OUT OF CATHETER. PATIENT WAS OK. A STENT WAS FRACTURE AND BROKE AND LEFT IN PATIENT, DOCTOR ANGIOPLASTIED STENT TO WALL IN COMMON FEMORAL. NO ADVERSE EFFECTS. THE SECOND AND THIRD DEVICE FELT TIGHTNESS UPON SCROLLING BACK, DECIDED TO REMOVE DEVICE COMPLETELY. SAFELY REMOVED DEVICE, PATIENT FINE, NO ADDITIONAL PRODUCTS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8394691 ↗
• MalfunctionNov 22, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS, "CONTRALATERAL ACCESS THROUGH 6 F SHEATH. STENT PREPPED ACCORDING TO IFU. LOADED AND ADVANCED ON .018 WIRE (DOESN¿T REMEMBER WHICH ONE). NO ISSUES WITH GETTING STENT DELIVERY SYSTEM IN PLACE. PRESSED RED BUTTON TO UNLOCK, HEARD AUDIBLE CLICK. STENT STARTED TO OPEN OUT OF DELIVERY SYSTEM BUT STOPPED. KEPT ROLLING AND WOULDN¿T COME OUT OF DELIVERY SYSTEM. HAD TO REMOVE FROM OUT OF BODY AND PUT NEW STENT IN, WHICH WORKED FINE. NO HARM TO PATIENT OR ADDITIONAL PROCEDURES REQUIRED. HAVE STENT TO SEND BACK- PLEASE ISSUE RGA."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8098808 ↗
• InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO CUSTOMER RELATIONS: "PATIENT HAD A PROCEDURE AT OUTPATIENT FACILITY ((B)(4)) ON TUESDAY, (B)(6) 2018; WAS ADMITTED TO SEPARATE FACILITY (UNKNOWN WHAT FACILITY AT THIS TIME ON WEDNESDAY, (B)(6) 2018 AND DIAGNOSED WITH SEPSIS. SEVERAL COOK PRODUCTS WERE INVOLVED WITH ORIGINAL PROCEDURE, UNKNOWN AND NOT ALLEGED AT THIS TIME IF ANY OF THEM MAY HAVE CONTRIBUTED TO THIS." DM MAY BE PULLING ALL PRODUCT FROM SAME LOT NUMBERS (AS MENTIONED IN PRODUCT NOTES FIELD TO RETURN FOR EVALUATION. ADDITIONAL INFORMATION PROVIDED BY DM ON 13JUN2018: "I MET WITH CUSTOMER ON MONDAY AND SO FAR THE REPORT IS THAT THE PATIENT WAS TREATED WITH FLUIDS AND IV ANTIBIOTICS AND IS DOING FINE WITH NO FURTHER COMPLICATIONS. THE PHYSICIAN WAS GOING TO TRY TO GET THE LAB RESULTS FOR THE STRAIN OF STREP THAT WAS IDENTIFIED IN CASE WE NEED THAT BUT IT WILL PROBABLY TAKE A FEW MORE DAYS."

  Patient problems: Sepsis

  MAUDE report 7645728 ↗
• MalfunctionJun 12, 2018Stretched; Delivery System Failure; Activation Failure; Stretched; Delivery System Failure; Activation Failure

  THIS FOLLOW UP REPORT IS BEING SUBMITTED TO UPDATE THE INVESTIGATION RESULTS INITIAL MDR SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: "THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT", " DEPLOYMENT DIFFICULTIES RESULTING IN PARTIAL STENT DEPLOYMENT" AND ¿STENT ELONGATION", AS REPORTED TO CUSTOMER RELATIONS "THE PHYSICIAN WAS DEPLOYING THE STENT AND TWO-THIRDS OF THE STENT DEPLOYED AND THE REMAINDER WOULD NOT DEPLOY. IT FELT LIKE THE DEVICE LOCKED. THE PHYSICIAN TOOK A KYCHOPLASTY KIT AND HE BROKE THE HANDLE OF THE STENT WITH KIT AND THEN PULLED ON THE INNER MECHANISM TO FINISH DEPLOYING THE STENT. THE FINAL THIRD OF THE STENT STRETCHED UPON DEPLOYMENT. THE PHYSICIAN THEN OVERLAPPED A SECOND ZILVER PTX OVER THE STRETCHED PART OF THE FIRST STENT TO COMPLETE THE PROCEDURE. THE PHYSICIAN SAID IT LOOKED BEAUTIFUL AFTER THE SECOND STENT WAS DEPLOYED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7590698 ↗
• MalfunctionMar 30, 2018Delivery System Failure; Delivery System Failure

  THIS FOLLOW UP MDR IS BEING SUBMITTED TO UPDATE THE INVESTIGATION DETAILS. INITIAL MDR SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT" AND "RETRACTION WIRE SEPARATED FROM STENT RETRACTION SHEATH." THE THUMBWHEEL FROZE DURING THE STENT DELIVERY; THE DEVICE WAS PARTIALLY DEPLOYED AT THIS TIME. THE HANDLE HAD TO BE BROKE OPEN AND THE WIRE WAS CUT TO MANIPULATE THE DEVICE TO DEPLOY. THE STENT WAS NOT ABLE TO BE DEPLOYED IN THE TARGET SITE, SO AN ADDITIONAL DEVICE (G38490) WAS PLACED TO COVER THE TARGETED AREA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7384810 ↗
• InjuryDec 29, 2017Fracture; Delivery System Failure; Fracture; Delivery System Failure

  AS REPORTED TO CUSTOMER RELATIONS: " DURING AN ENDOVASCULAR PROCEDURE IN THE SFA THE ZILVER PTX 35 DRUG-ELUTING STENT WAS USED. THE PHYSICIAN ADVANCED THE PTX OVER THE A 260 CM BENTSON WIRE AND DOWN INTO THE MID-SFA ; HIT THE RED BUTTON AND BEGAN TO DEPLOY. DEPLOYED APPROXIMATELY 10-15 MM AND THE DELIVERY SYSTEM FAILED. PHYSICIAN CONTINUED WHEELING THE THUMBWHEEL AND STENT WOULD NOT COME OUT. PHYSICIAN PULLED BACK ON DELIVERY SYSTEM AND AS REACHED THE JUNCTION AT TOP OF SFA THE STENT GOT STUCK AND THE 10-15 MM PORTION THAT HAD DEPLOYED BROKE OFF. THE REMAINDER OF THE PTX DEVICE WAS PULLED OUT THROUGH THE SHEATH. A NEW ZILVER 7X100 WAS PLACED WHERE INTENDED TO PLACE THE FIRST STENT. THIS STENT WAS PLACED SUCCESSFULLY. IT WAS DECIDED BY THE PHYSICIAN TO USE A BALLOON EXPANDABLE STENT TO JAIL THE PORTION OF THE PTX TO THE SIDE WALL OF THE SFA. ADVANCED A BOSTON 8X27 EXPRESS STENT TO THE FRACTURED STENT AND JAILED THE STENT BETWEEN THE WALL OF THE ARTERY AND THE FRACTURED EXPANDABLE STENT. DID AN ARTERIOGRAM- LUMEN WAS OPEN, NO DISSECTION, NO PATIENT HARM. "

  Patient problems: Foreign Body In Patient

  MAUDE report 7153825 ↗
• InjuryDec 20, 2017Fracture; Fracture

  THIS FOLLOW UP REPORT IS BEING SUBMITTED TO UPDATE THE INVESTIGATION FINDINGS. THE DEVICE WAS FULLY DEPLOYED. POST DILATED WITH A CHOCOLATE BALLOON (MEDTRONIC) AND UPON DEFLATION, THE NITINOL CAGE OF THE CHOCOLATE BALLOON ENTANGLED THE STENT WITHOUT THE USER KNOWING AND UPON REMOVING THE BALLOON, THE STENT WAS FRACTURED AND DISLODGED 1CM IN THE COMMON FEMORAL ARTERY. ELECTED TO SEND PATIENT TO OR TO HAVE THE PORTION OF THE DEVICE REMOVED.

  Patient problems: No Code Available

  MAUDE report 7133866 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED TO THE ER ABOUT 24 HOURS AFTER THE PLACEMENT OF THE ZILVER PTX WITH PAIN IN THE AREA OF WHERE THE STENTS WERE PLACED. THE PHYSICIAN INDICATED THE PATIENT WAS HAVING A HARD TIME BEARING WEIGHT ON THAT LEG WHERE THE STENTS WERE PLACED. THE PHYSICIAN DID STATE THE STENTS WERE PATENT AND THE PATIENT DID HAVE A PULSE IN THAT FOOT. AS 2 STENTS ARE SUSPECTED TO BE INVOLVED IN THIS EVENT A SEPARATE REPORT HAS BEEN SUBMITTED FOR EACH SUSPECT DEVICE. REFERENCE ALSO REPORT # 3001845648-2017-00573.

  Patient problems: Pain

  MAUDE report 7070719 ↗
• InjuryOct 12, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM FDA THAT INVESTIGATION INTO THIS EVENT IS COMPLETE AND THE CONCLUSION OF THIS INVESTIGATION HAS BEEN UPDATED. INITIAL REPORT DETAILS: PATIENT UNDERWENT A LOWER EXTREMITY ANGIOGRAM WITH POSSIBLE INTERVENTION OF RLE WHICH THE ZILVER PTX 35 DRUG-ELUTING STENT WAS USED. STILL WAITING FOR FURTHER INFORMATION. DISTRICT MANAGER INTERPRETATION OF WHAT HAPPENED ON 9-12-2017: ONE OF THE ZILVER PTX STENTS DID NOT DEPLOY CORRECTLY INSIDE OF A PREVIOUSLY PLACED BARD LIFESTENT AT WHICH POINT IN TIME PHYSICIAN HAD TO WITHDRAW THE WIRE, STENT CATHETER, AND ANSEL SHEATH. UPON PULLING THIS OUT OF THE CONTRALATERAL GROIN (LEFT GROIN) THE MAL-DEPLOYED ZILVER PTX INTERACTED WITH A PREVIOUSLY PLACED ZILVER BMS IN THE LEFT COMMON ILIAC ARTERY. OPEN PROCEDURE TO REMOVE ZILVER PTX THAT WAS STUCK IN THE LEFT CFA, THERE IS HIGH SUSPICION THAT THE LCIA STENT WAS EXPLANTED AS WELL. PER THE DISTRICT MANAGER REGARDING THE INQUIRY OF PATIENT OUTCOME: "THE INITIAL OPEN PROCEDURE WAS SUCCESSFUL AT REMOVING THE FOREIGN BODY (STENT) FROM THE LEFT GROIN, HOWEVER PATIENT ENDED UP HAVING TO HAVE BILATERAL BKA'S. ADDITIONAL INFORMATION RECEIVED ON 26-SEP-17 AS FOLLOWS: W

  Patient problems: Foreign Body In Patient; Thrombosis

  MAUDE report 6943535 ↗
• MalfunctionSep 1, 2017Difficult to Remove; Delivery System Failure; Difficult to Remove; Delivery System Failure

  WE HAD A CASE ON (B)(6) 2017 WHERE THE MAGIC TORQUE WIRE WOULD NOT COME OUT OF THE SYSTEM AFTER DEPLOYING THE STENT. STENT WAS DEPLOYED SAFELY, MAGIC TORQUE WIRE COULD NOT BE REMOVED FROM DELIVERY SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6837552 ↗
• MalfunctionMay 11, 2017Device Expiration Issue; Device Expiration Issue

  EXPIRED STENT WAS PLACED. PROCEDURE WENT WELL AND AS INTENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6559642 ↗