Zilver PTX G38479Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10827002384795), received between Aug 2, 2017 and Apr 13, 2022 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2022Fracture; Structural Problem; Fracture; Structural Problem

  NOTED DURING ROUTINE FOLLOW UP ULTRASOUND: PATIENT IS ASYMPTOMATIC. STENT APPEARED FRACTURED; CAT SCAN SHOWS SEPARATED FRAGMENTS WHICH HAVE CREATED A PSEUDOANEURYSM IN THE PROXIMAL SFA. STENT WAS PLACED IN 2019 DURING A AAA (STENT GRAFT). IMAGINE REVIEW COMPLETED ON 06-APR-2022: IMPRESSION: THE IMAGES CONFIRM A TYPE III STENT FRACTURE AND PSEUDOANEURYSM. THE IMAGES DO NOT CONFIRM THAT THE FRACTURE CAUSED THE PSEUDOANEURYSM BECAUSE THE PSEUDOANEURYSM PRECEDED THE FRACTURE. THE PROXIMAL RIGHT SFA STENT IMPLANTATION LOCATION WOULD HAVE SUBJECTED THE STENT TO REPETITIVE STRESS FROM HIP FLEXION. BY REMOVING VESSEL WALL SUPPORT FROM THE STENT, THE PSEUDOANEURYSM INCREASED THE REPETITIVE STRESS EXERTED ON THE STENT DURING HIP FLEXION. WAS THE DEVICE FLUSHED BEFORE THE PROCEDURE, AS PER IFU? N/A, YES, NO. WERE THERE ANY ISSUES WITH FLUSHING OF THE DEVICE? N/A, YES, NO. DETAILS OF THE ACCESS SHEATH USED (NAME, FR SIZE,LENGTH)? DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHYLIC)? WHAT APPROACH WAS USED TO ACCESS THE TARGET SITE? CONTRALATERAL, IPSILATERAL, ANTEGRADE, RETROGRADE, OTHER. PLEASE SPECIFY FOR OTHER: IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? N/A, YES, NO. WHAT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102365 ↗
• InjuryFeb 25, 2022Fracture; Fracture

  REPORTED BY THE DM VIA PHONE CALL THE PHYSICIAN DID A ROUTINE FOLLOW UP ON THE PATIENT, DURING THE ULTRASOUND IT WAS DISCOVERED HE DEVICE WAS FRACTURED IN HALF. THE PHYSICIAN HAS INTENTIONS TO COVER WITH A NEW COVERED STENT. THE FOLLOWING HAS BEEN ANSWERED- (B)(6), 28JAN2022. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NOT YET DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? YES IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. ADDITIONAL PROCEDURE INFORMATION IS NOT AVAILABLE CURRENTLY. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE THIS OCCURRENCE? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13602506 ↗
• InjuryFeb 22, 2022Fracture; Structural Problem; Fracture; Structural Problem

  REPORTED BY THE DM VIA PHONE CALL THE PHYSICIAN DID A ROUTINE FOLLOW UP ON THE PATIENT, DURING THE ULTRASOUND IT WAS DISCOVERED HE DEVICE WAS FRACTURED IN HALF. THE PHYSICIAN HAS INTENTIONS TO COVER WITH A NEW COVERED STENT. THE FOLLOWING HAS BEEN ANSWERED: (B)(6), (B)(6) 2022. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NOT YET. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? YES. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. ADDITIONAL PROCEDURE INFORMATION IS NOT AVAILABLE CURRENTLY. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE THIS OCCURRENCE? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578290 ↗
• MalfunctionApr 24, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT SHORTENING/ COMPRESSION DURING DEPLOYMENT'. AS REPORTED TO CUSTOMER RELATIONS: "PHYSICIAN TOLD ME THE PATIENT WAS BROUGHT BACK TO THE FACILITY AFTER A FIRST PROCEDURE--THE FIRST TIME, THEY PLACED A 7MM ZILVER PTX IN THE SFA. THERE WAS A DISSECTION THAT HAD ALREADY OCCURRED THAT THE PHYSICIAN WANTED TO FIX, SO HE PUT A BALLOON IN, PRIOR TO PUTTING IN A 6X100 PTX. WANTED TO LAY ANOTHER 6X60 AFTER THAT, AND WHEN HE WENT TO DEPLOY THE 6X60 HE SAID THE STENT BUNCHED UP ON ITSELF, LEADING TO A SHORTENING OF ABOUT 2/3 THE LENGTH (SO 6X60 LOOKED LIKE A 6X20).

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8544512 ↗
• InjuryFeb 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 AN ARTERIOGRAM OF THE LOWER LEG WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT WAS PERFORMED AND 5 COOK STENTS WERE PLACED. NO FLOW WAS NOTED, AND THE PHYSICIAN INDICATED THEY DID NOT BELIEVE IT WAS DUE TO THE DEVICES. ON (B)(6) 2019 THE DM FOLLOWED UP TO CHECK ON THE PATIENT, AND THE PHYSICIAN INFORMED THE DM THAT THE PATIENT HAD TO HAVE AMPUTATION (UNKNOWN LOCATION). PATIENT IS STABLE AND HEALING WELL.

  Patient problems: Disability; Hypovolemia

  MAUDE report 8339320 ↗
• InjuryJan 10, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING DEPLOYMENT OF THE STENT IN THE PROXIMAL POPLITEAL, WHEN THE STENT WAS APPROXIMATELY A QUARTER OF THE WAY DEPLOYED, THE THUMB WHEEL BROKE. THE USER ATTEMPTED TO CRACK OPEN THE HANDLE TO MANUALLY DEPLOY THE STENT, BUT THIS WAS UNSUCCESSFUL. THE USER PULLED BACK ON THE SYSTEM AND THE STENT DEPLOYED. THE STENT DEPLOYED INSIDE PREVIOUSLY PLACED STENT, WHICH WAS NOT THE INTENDED TARGET LOCATION FOR THE STENT PLACEMENT. THE USER BALLOONED THE STENT TO SECURE IT AND THEN PROCEED TO PLACE A ZILVER 518 TO COMPLETE THE INTENDED PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8235354 ↗
• MalfunctionDec 29, 2017Delivery System Failure; Delivery System Failure

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS:THE PHYSICIAN WAS DEPLOYING THE STENT AND AS IT WAS ABOUT 2/3 DEPLOYED, THE THUMBWHEEL STOPPED TURNING. HE WAS ABLE TO BREAK OPEN THE HANDLE AND PULLED ON SOME OF THE WIRES AND DEPLOYED THE REST OF THE WAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7153824 ↗
• MalfunctionSep 4, 2017Delivery System Failure; Activation, Positioning or Separation Problem; Delivery System Failure; Activation, Positioning or Separation Problem

  AS THE FACILITY WAS TURNING THE WHEEL AND RETRACTING THE COVER OF THE STENT, THE CABLE BROKE. ONLY ABOUT 2CM'S OF THE DEVICE WAS DEPLOYED IN THE PATIENT. AT THIS POINT THE WHEEL WOULD TURN FREELY AS IT FELT LIKE IT WAS NOT CONNECTED TO ANYTHING. TO GET THE STENT OFF THE DEPLOYMENT SYSTEM, THE PHYSICIAN PULLED THE UNIT BACK AND THE STENT DEPLOYED ON ITS OWN. THE STENT DID ELONGATE PASSED THE OSTEUM OF THE SFA INTO THE PATIENT'S COMMON FEMORAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6841017 ↗
• MalfunctionAug 23, 2017Difficult to Remove; Difficult to Remove

  THIS REPORT FORMS PART OF A RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOR A NEW MALFUNCTION PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY. THE CUSTOMER WAS USING 6 FR BALKAN SHEATH WITH EXTRA STIFF AMPLATZ WIRE WITH A 6 FR ZILVER PTX. WHEN THEY PUT THE PTX OVER THE WIRE, IT WAS QUITE STIFF. ONCE THEY DEPLOYED THE STENT AND TRIED TO GET IT OFF THE WIRE, IT WAS STUCK/JAMMED ON THE WIRE. THEY HAD TO TAKE EVERYTHING OUT. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH OTHER DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6812949 ↗
• MalfunctionAug 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  UPON OPENING THE PACKAGE, A CONTAMINANT WAS FOUND WITHIN THE STERILE PACKAGING. THE DEVICE WAS NOT USED / DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6759720 ↗