Zilver PTX G38482Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10827002384825), received between Jun 8, 2016 and Jul 25, 2025 — classified as 23 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (21 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 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER REP - 01JUL2025 - FIVE STENTS WERE IMPLANTED IN THE RIGHT LEG (RIGHT SFA) ON (B)(6) 2025. THE PATIENT CAME BACK FOR AN ANGIOGRAM ON (B)(6) 2025 AND THEY DISCOVERED THROMBOSIS IN ALL FIVE STENTS. THE DOCTOR BELIEVES THAT THIS WAS DUE TO A HEAVILY CALCIFIED SFA. THE PATIENT MAY REQUIRE A BYPASS. DEVICE REMAIN INSIDE PATIENT - STENTS REMAIN IN PATIENT. WAS PATIENT HOSPITALIZED - UNKNOWN. DELAY OR ADDITIONAL PROCEDURE - POSSIBLE BYPASS. ADDITIONAL PROCEDURE DUE TO PRODUCT - UNKNOWN. ADVERSE EFFECTS ON PATIENT - UNKNOWN. ADV EFFECTS DUE TO PRODUCT - UNKNOWN. ARE IMAGES (E.G., ANGIOGRAPHY, US ETC.) OF THE DEVICE AND/OR PROCEDURE AVAILABLE? N/A, YES, NO -UNKR. WAS THE DEVICE FLUSHED BEFORE THE PROCEDURE, AS PER IFU? N/A, YES, NO -YES. WERE THERE ANY ISSUES WITH FLUSHING OF THE DEVICE? N/A, YES, NO -NO. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? -N/A. 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) -N/A. WHAT WAS THE TARGET LOCATION FOR THE STENT? -RIGHT SFA. WHAT ARTERY WAS THE STENT PLACED IN? PROXIMAL SFA, MID SFA,

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22607989 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FIVE STENTS WERE IMPLANTED IN THE RIGHT LEG (RIGHT SFA) ON (B)(6) 2025. THE PATIENT CAME BACK FOR AN ANGIOGRAM ON (B)(6) 2025 AND THEY DISCOVERED THROMBOSIS IN ALL FIVE STENTS. THE DOCTOR BELIEVES THAT THIS WAS DUE TO A HEAVILY CALCIFIED SFA. THE PATIENT MAY REQUIRE A BYPASS. DEVICE REMAIN INSIDE PATIENT - STENTS REMAIN IN PATIENT. WAS PATIENT HOSPITALIZED - UNKR. DELAY OR ADDITIONAL PROCEDURE - POSSIBLE BYPASS. ADDTL PROCEDURE DUE TO PRODUCT - UNKR. ADVERSE EFFECTS ON PATIENT - UNKR. ADV EFFECTS DUE TO PRODUCT - UNKR. ARE IMAGES (E.G., ANGIOGRAPHY, US ETC.) OF THE DEVICE AND/OR PROCEDURE AVAILABLE? N/A, YES, NO -UNKR. WAS THE DEVICE FLUSHED BEFORE THE PROCEDURE, AS PER IFU? N/A, YES, NO -YES. WERE THERE ANY ISSUES WITH FLUSHING OF THE DEVICE? N/A, YES, NO -NO. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? -N/A. 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) -N/A. WHAT WAS THE TARGET LOCATION FOR THE STENT? -RIGHT SFA. WHAT ARTERY WAS THE STENT PLACED IN? PROXIMAL SFA, MID SFA, DISTAL SFA, AT THE OSTIUM OF THE PROFUN

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22472610 ↗
• MalfunctionMay 6, 2025Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  PER THE COMPLAINT EMAIL FROM THE FIELD REPRESENTATIVE: "THE 6 BY 120 PTX THAT WAS IN A 6FR 45CM ANSEL SHEATH UP AND OVER THAT WHERE THE FIRST AND SECOND PHYSICIANS AT THE MEDICAL CENTER WENT TO FULLY DEPLOY AFTER THE FIRST PHYSICIAN DOING THE THUMB WHEEL COMPLETELY, ABOUT 1CM WAS COMPLETELY STILL NOT DEPLOYED AND STUCK. THE SECOND PHYSICIAN MADE A PHONE CALL TO ME TO SEE WHAT OPTIONS WE HAD. BY THE TIME WE DISCUSSED, THE FIRST PHYSICIAN WAS ABLE TO GET THE END OF IT OUT AS HE PULLED IT BACK. BUT THEY SAID IT WAS STRANGE AS IT WASN'T FULLY EXPANDED. THEY SAVED DEPLOYMENT DEVICE." PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967054 ↗
• MalfunctionMay 30, 2024Improper or Incorrect Procedure or Method; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Physical Resistance/Sticking

  DESCRIPTION OF EVENT: PER REP - 06MAY2024 - THE PHYSICIAN SAID THE STENT WOULD NOT DEPLOY. PATIENT OUTCOME: UNKR PATIENT/EVENT INFO - NOTES: PREFIX ZIV6-PTX/ZISV6-PTX 3.60 ARE IMAGES (E.G. ANGIOGRAPHY, US ETC.) OF THE DEVICE AND/OR PROCEDURE AVAILABLE? N/A, YES, NO 3.61 WAS THE DEVICE FLUSHED BEFORE THE PROCEDURE, AS PER IFU? N/A, YES, NO 3.62 WERE THERE ANY ISSUES WITH FLUSHING OF THE DEVICE? N/A, YES, NO 3.63 DETAILS OF THE ACCESS SHEATH USED (NAME, FR SIZE,LENGTH)? 3.64 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? 3.65 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 3.66 WHAT WAS THE TARGET LOCATION FOR THE STENT? 3.67 WHAT ARTERY WAS THE STENT PLACED IN? PROXIMAL SFA, MID SFA, DISTAL SFA, AT THE OSTIUM OF THE PROFUNDA, P1 (PROXIMAL POPLITEAL), OTHER PLEASE SPECIFY FOR OTHER: 3.68 WAS THE WIRE GUIDE REMOVED FROM THE PATIENT PRIOR TO ADVANCING THE DELIVERY SYSTEM? N/A, YES, NO 3.69 IF REMOVED, WAS THE WIRE GUIDE WIPED PRIOR TO ADVANCEMENT OF THE DELIVERY SYSTEM? N/A, YES, NO 3.70 DID THE STENT DELIVERY SYSTEM CROSS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19426127 ↗
• MalfunctionMar 12, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 24-JUL-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886259 ↗
• MalfunctionJan 9, 2023Failure to Advance; Activation, Positioning or Separation Problem; Failure to Advance; Activation, Positioning or Separation Problem

  SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 14-MAR-23 AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121029 ↗
• MalfunctionOct 13, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PER REP ON (B)(6) 2022 THE CUSTOMER STATED THAT THE PATIENT CAME BACK IN WITH INDURATED SKIN LESIONS. THEY WONDER IF THE PACLITAXEL MIGHT BE RESPONSIBLE FOR THIS. LEG ANGIOGRAM WITH PACLITAXEL STENT PLACEMENT PATIENT OUTCOME: 6.3.1.1 DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. 6.3.1.2 WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? NO. 6.3.1.3 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. 6.3.1.4 DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 6.3.1.5 HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? POSSIBLY. 6.3.1.6 HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? POSSIBLY. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. INDURATED SKIN LESIONS. ADDITIONAL INFO: 3.60 ARE IMAGES (E.G. ANGIOGRAPHY, US ETC.) OF THE DEVICE AND/OR PROCEDURE AVAILABLE? N/A, YES, NO? NO. 3.61 WAS THE DEVICE FLUSHED BEFORE THE PROCEDURE, AS PER IFU? N/A, YES, NO? YES.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 15596433 ↗
• InjuryOct 12, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE INITIAL REPORTER, POST A LEG ANGIOGRAM WITH PACLITAXEL STENT PLACEMENT PROCEDURE, THE INITIAL REPORTER STATED THAT THE PATIENT CAME BACK IN WITH INDURATED SKIN LESIONS. THEY WONDER IF THE PACLITAXEL MIGHT BE RESPONSIBLE FOR THIS.

  Patient problems: Reaction to Medicinal Component of Device

  MAUDE report 15589425 ↗
• InjuryJun 3, 2022Fracture; Fracture

  ACCORDING TO THE INITIAL REPORTER "THE STENT WAS IMPLANT AND LOOKED GREAT UPON IMPLANTATION. TODAY, THE PATIENT WAS BROUGHT BACK IN FOR THE STENT TO PLACED IN THE OTHER LEG. HOWEVER, IMAGE REVIEW THE STENT THAT WAS ALREADY PLACED ((B)(6) 2022) HAD COMPLETELY SEPARATED INTO TWO PIECES." THE SEPARATED STENT IS BEING LEFT IN THE PATIENT AT THIS POINT. THE PHYSICIAN WILL BE PERFORMING AN ULTRASOUND (TO CONFIRM FLOW / AND POSSIBLE 'BRIDGING STENT' PLACEMENT - TO ENSURE FLOW) TO DECIDE THE BEST FORM OF SUBSEQUENT ACTION. PER PHONE CONVERSATION WITH THE COOK REPRESENTATIVE ON (B)(6) 2022: THE PATIENT'S LEG WAS BENT WHEN THE STENT WAS DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14595668 ↗
• InjuryApr 12, 2022Fracture; Improper or Incorrect Procedure or Method; Structural Problem; Fracture; Improper or Incorrect Procedure or Method; Structural Problem

  AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "THE STENT WAS IMPLANT AND LOOKED GREAT UPON IMPLANTATION. TODAY, THE PATIENT WAS BROUGHT BACK IN FOR THE STENT TO PLACED IN THE OTHER LEG. HOWEVER, IMAGE REVIEW THE STENT THAT WAS ALREADY PLACED ((B)(6)2022) HAD COMPLETELY SEPARATED INTO TWO PIECES." NOTE: THE SEPARATED STENT IS BEING LEFT IN THE PATIENT AT THIS POINT. THE PHYSICIAN WILL BE PERFORMING AN ULTRASOUND (TO CONFIRM FLOW / AND POSSIBLE 'BRIDGING STENT' PLACEMENT - TO ENSURE FLOW) TO DECIDE THE BEST FORM OF SUBSEQUENT ACTION. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? NOT AT THIS TIME. PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NONE REPORTED TO THE DM. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NONE REPORTED TO THE DM . PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. PREFIX ZIV6-PTX/ZISV6-PTX 3.60 ARE IMAGES (E.G. AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14084428 ↗
• InjuryMar 24, 2021Break; Fracture; Structural Problem; Break; Fracture; Structural Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11564420 ↗
• InjuryMar 24, 2021Fracture; Fracture

  COMPLAINT RECEIVED FROM DM VIA E-MAIL ON (B)(6) 2021. AS REPORTED TO CUSTOMER RELATIONS: "STENTING THE SFA. WAS ABLE TO ROLL THE WHEEL BACK A LITTLE BIT THEN HEARD A "SNAPPING" NOISE. ABOUT 10MM OF THE 120MM STENT WAS EXPOSED AT THIS POINT. OPENED UP THE HANDLE TO TRY AND BYPASS THE WHEEL AND MANUALLY PULL THE INTERNAL METAL WIRE THAT RUNS INSIDE THE LENGTH OF THE ZPTX DEPLOYMENT SYSTEM. THIS WAS NOT SUCCESSFUL. THEY THEN TRIED TO PULL THE WHOLE SYSTEM UP INTO THE SHEATH. SO HERE THEY ARE PULLING ON THE DEPLOYMENT SYSTEM AND PUSHING THE SHEATH IN. THIS CAUSED THE STENT TO FRACTURE AND THE EXPOSED 10MM (APPROXIMATELY) TO BE LEFT BEHIND IN THE SFA. WHILE THE REMAINDER OF THE STENT AND DEPLOYMENT SYSTEM, WAS THEN REMOVED FROM THE SHEATH." ADDITIONAL INFORMATION PROVIDED BY DM ON (B)(6) 2021: "I¿D ALSO LIKE TO GET A ZERO DOLLAR REPLACEMENT SENT OUT TO REPLACE THIS STENT. BELOW IS THE INFO I HAVE ON THE STENT IN QUESTION PRODUCT DESCRIPTION: ZILVER PTX STENT 6MM X 120 MM 6FR, G38482, LOT#C1656615, EXPIRATION:3-11-21". ADDITIONAL INFORMATION PROVIDED BY DM ON 02MAR2021: "HOW WAS THE PROCEDURE COMPLETED? YES. ADDITIONAL INFORMATION PROVIDED BY DM ON 09MAR2021: "HOW WAS THE PROCEDURE COMPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11562898 ↗
• MalfunctionApr 4, 2019Difficult to Remove; Difficult to Remove

  AS REPORTED TO CUSTOMER RELATIONS: "THE INITIAL ISSUE WAS THAT THERE AS A COOK ROSEN WIRE IN, AND WHEN THEY WENT TO ADVANCE THE DELIVERY SYSTEM OVER THE BIFURCATION THEY WERE UNABLE TO (DIFFICULT BIFURCATION, PER PHYSICIAN). THEY CHANGED OUT THE WIRE TO A BOSTON AMPLATZ WIRE AND CHANGED OUT THE SHEATH TOO. AT THIS POINT THEY WERE ABLE TO ADVANCE AND DEPLOY. WHEN THEY WENT TO REMOVE DELIVERY SYSTEM, THEY WERE UNABLE TO PULL IT OUT OVER THE WIRE, SO THEY HAD TO REMOVE IT WITH THE WIRE (LOST ACCESS IN THE PATIENT AT THIS POINT). DEVICE WILL BE RETURNED WITH THE BOSTON WIRE. DM BELIEVES PROCEDURE WAS COMPLETED SUCCESSFULLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8482167 ↗
• InjuryJan 8, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS, "MID-DISTAL SFA INTERVENTION. THE STENT WAS DEPLOYED IN NORMAL FASHION, BUT AT SOME POINT THE DISTAL END OF THE STENT WAS INVERTED OR PULLED BACK UP INTO THE STENT. IT APPEARS THE WIRE GOT ENTRAPPED IN THE STENT, POSSIBLY. THERE WAS A LARGE DISSECTION DISTAL TO THE STENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8225834 ↗
• MalfunctionJan 3, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS, "THE DOCTOR WAS DEPLOYING THE DEVICE BACKWARDS AND AFTER 3 CLICKS, THE DEVICE JUST STOPPED AND THE STENT DID NOT DEPLOY. THE COMPLAINT DEVICE WAS REMOVED AND A NEW G38482-ZISV6-35-125-6-120-PTX WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8211406 ↗
• MalfunctionNov 9, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE STENT WOULD NOT DEPLOY. NO PART OF THE STENT WAS DEPLOYED. THE SAFETY BUTTON WAS PUSHED AND THE THUMBWHEEL WOULD SPIN, BUT WOULD NOT EXPOSE STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8054263 ↗
• MalfunctionJul 11, 2018Fracture; Activation Failure; Fracture; Activation Failure

  INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT", ¿DEPLOYMENT DIFFICULTY RESULTING IN PARTIAL STENT DEPLOYMENT¿. AS REPORTED TO CUSTOMER RELATIONS, "THE THUMBWHEEL STOPPED WORKING AND SO THE STENT WOULD NOT DEPLOY. A NEW ZILVER STENT WAS OPENED AND USED TO COMPLETE THE PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7677449 ↗
• MalfunctionMay 15, 2018Fracture; Delivery System Failure; Fracture; Delivery System Failure

  INITIAL MDR IS BEING SUBMITTED BASED ON SERIOUS INJURY. SURGICAL INTERVENTION WAS PERFORMED. AS REPORTED TO CUSTOMER RELATIONS: "WHILE BEING DEPLOYED, THUMBWHEEL DEVICE STOPPED WORKING (WHEEL WAS TURNING FREELY). WHEN PHYSICIAN STARTED PULLING THE DEVICE BACK OUT, THE STENT DETACHED. REQUIRED ANOTHER STENT IN ANOTHER LOCATION, BUT DURING THE SAME PROCEDURE". ADDITIONAL INFORMATION PROVIDED BY DM ON 20APR2018: (QUESTION: IT WAS NOTED ON THE FILE THAT THE STENT PARTIALLY DEPLOYED. DID THE STENT DEPLOY IN THE PATIENT? IF SO, HOW WAS THE STENT REMOVED?) STENT WAS NO REMOVED. THEY SMASHED IT WITH ANOTHER STENT. ADDITIONAL INFORMATION PROVIDED BY DM ON 23APR2018: "THE FIRST STENT WAS NOT DEPLOYED UNINTENTIONALLY. DUE TO THE SYSTEM BREAKING-HE HAD ALREADY DEPLOYED SOME OF THE STENT AND AS HE WAS DRAGGING THE SYSTEM BACK, THE STENT BROKE OFF INTO ANOTHER STENT THAT WAS THERE. HE THEN HAD TO PUT IN ANOTHER STENT (DIFFERENT COMPANY) TO SMASH THE STENT PORTION THAT WAS BROKEN OFF FROM OUR SYSTEM. I¿M NOT SURE THIS IS CLASSIFIED AS A FRACTURE?".

  Patient problems: Foreign Body In Patient

  MAUDE report 7514145 ↗
• MalfunctionMay 2, 2018Fracture; Delivery System Failure; Fracture; Delivery System Failure

  INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: 'STENT FRACTURE' AND 'RETRACTION WIRE SEPARATES FROM STENT RETRACTION SHEATH'. AS REPORTED TO CUSTOMER RELATIONS, "THEY WERE DEPLOYING THE ZILVER PTX STENT AND ABOUT A QUARTER OF THE WAY DEPLOYING, THE WIRE INSIDE THE RETRACTING SYSTEM BROKE AND THEY WERE UNABLE TO COMPLETE THE DEPLOYMENT. THEY OPENED UP THE HANDLE TO TRY TO GET THE RETRACTING WIRE AND WERE UNABLE TO DO SO. THEY CALLED PRODUCT SPECIALIST, (B)(6), AND SUGGESTED PULLING BACK ON THE WHOLE SYSTEM. UPON DOING THAT, THE STENT BROKE AND A QUARTER OF THE STENT STAYED IN THE PATIENT AND THE REST OF THE STENT IS STILL IN THE DELIVERY SYSTEM. THEY OPENED UP AN ADDITIONAL PTX AND DEPLOYED OVER THE FIRST ONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DM ALSO NOTED THAT THE PATIENT HAD SEVERE OSTEOARTHRITIS IN HER JOINTS. HER LEG WAS BENT 90 DEGREES WITH HER FOOT ON THE TABLE. MAYBE THE ANGLES PUT EXTRA STRESS THE WIRES."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7479259 ↗
• MalfunctionApr 10, 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, "STENT DELIVERY SYSTEM WAS DELIVERED WITH DIFFICULTLY ACROSS BIFURCATION AND TO LEFT SFA OCCLUSION. DURING DELIVERY OF ZILVER PTX STENT THE DELIVERY WHEEL STOPPED MOVING AND EVENTUALLY SNAPPED. MD HAD BREAK APART HANDLE OF DELIVERY SYSTEMS TO MANUALLY COMPLETE THE STENT PLACEMENT. PROCEDURE FINISHED WITHOUT FURTHER ISSUES. ANOTHER STENT FROM ANOTHER MANUFACTURER WAS PLACED THROUGH THE ZILVER PTX TO COMPLETE STUDY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7412431 ↗
• MalfunctionApr 10, 2018Delivery System Failure; Delivery System Failure

  INITIAL MDR IS BEING SUBMITTED BASED ON MALFUNCTION PRECEDENCE. THEY HAD A 6X45 CM LONG SHEATH OVER BIFURCATION AND PUT A ZILVER ACROSS IT AND GOT IT LINED UP TO DEPLOY. WHEN TRYING TO USE THE THUMBWHEEL, THEY MET A LOT OF RESISTANCE. THE ZILVER KINKED ON THE INSIDE OF THE SHEATH WHERE IT CROSSES THE ILIAC BIFURCATION. THEY TOOK IT OUT AND UTILIZED ANOTHER DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7410537 ↗
• MalfunctionApr 3, 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: "PUT STENT IN, STARTED TO DEPLOY IT, THE WHEEL STOPPED WORKING WHEN PHYSICIAN WAS ROLLING IT BACK. AFTER WHEEL STOPPED WORKING, WAS ALSO GETTING STUCK ON WIRE. PHYSICIAN WENT BACK WITH BIGGER SHEATH AND USED ANOTHER DEVICE SUCCESSFULLY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7391791 ↗
• MalfunctionMar 22, 2018Kinked; Activation, Positioning or Separation Problem; Kinked; Activation, Positioning or Separation Problem

  INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE. AS REPORTED TO CUSTOMER RELATIONS, "THE ZILVER PTX WAS INSERTED THRU A 6FR SHEATH (UNKNOWN MAKE AND MODEL). DURING INSERTION, THE STENT ENCOUNTERED INCREASED RESISTANCE AT WHICH POINT, UPON SIGNIFICANT RESISTANCE THE PHYSICIAN CHOSE TO REMOVE AND INSPECT THE STENT. UPON REMOVAL AND INSPECTION, IT WAS NOTED THE STENT WAS ACCORDIONED. APPROXIMATELY 10 CM OF THE STENT WAS ACCORDIONED. AT THIS POINT, THE FACILITY CALLED THE REGIONAL MANAGER FOR SUPPORT / ADVICE ON HOW TO PROCEED. ITS UNKNOWN AT THIS TIME HOW THE PROCEDURE WAS COMPLETED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7361121 ↗
• MalfunctionMar 20, 2018Fracture; Fracture

  INITIAL MDR IS BEING SUBMITTED BASED ON SERIOUS INJURY: STENT FRACTURE WITH SURGICAL INTERVENTION PER REP - THE TECH WAS PREPPING STENT. SHE PUT A SYRINGE ON THE LUER LOCK END OF THE WIRE LUMEN. AT THAT POINT, SHE FLUSHED THE STENT SYSTEM AND ATTEMPTED TO DETACH THE SYRINGE FROM THE LUER LOCK OF THE WIRE LUMEN. SHE COULD NOT DETACH THE SYRINGE. AT THAT POINT, SHE GRABBED THE LUER LOCK END OF THE WIRE LUMEN WITH HEMOSTATS. SHE FORCED THE SYRINGE OFF OF THE LUER LOCK END. THE PHYSICIAN THEN TRIED TO THREAD THE STENT SYSTEM OVER THE WIRE AND THE WIRE WOULD NOT FEED THROUGH THE END OF THE LUER LOCK WIRE LUMEN ((B)(4)). THE PHYSICIAN THEN, OF HIS OWN VOLITION, REMOVED THE SYSTEM OVER THE WIRE AND BROKE OPEN THE DISTAL HANDLE OF THE STENT CATHETER. HE TOOK IT APART AND RETHREADED THE STENT SYSTEM OVER THE WIRE INTO THE PATIENT. HE TRIED TO DEPLOY THE STENT MANUALLY. IT PARTIALLY DEPLOYED INSIDE THE PATIENT. IT COULD NOT BE FULLY DEPLOYED. HE TRIED TO PULL IT BACK OUT OF THE PATIENT AND THE STENT FRACTURED ((B)(4)). HE WAS ABLE TO PULL THE REST OF THE SYSTEM OUT WITH A PIECE LEFT IN THE PATIENT. WHEN HE SAW THAT THIS HAD HAPPENED, HE UPSIZED HIS SHEATH FROM 6 FR TO 7 FR. HE THEN INSERTED

  Patient problems: Foreign Body In Patient

  MAUDE report 7353040 ↗
• MalfunctionFeb 28, 2018Delivery System Failure; Delivery System Failure

  THIS INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT¿ AND "DEPLOYMENT DIFFICULTY RESULTING IN PARTIAL STENT DEPLOYMENT" PER REP - AS THEY WERE ROLLING BACK THE THUMBWHEEL, THE SHEATH WOULD NOT FULLY RETRACT AND THE DEVICE WOULD NOT DEPLOY. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH A DRUG COATED BALLOON. UPDATE 01FEB2018 - PER REP - I WAS ABLE TO TALK WITH DR. (B)(6) ABOUT THE CASE. PATIENT HAD A STEEP BIFURCATION WITH A LARGE CHUNK OF CALCIUM AT THE PROXIMAL PORTION. HE USED CSI TO CUT THROUGH IT. WITH THE VIPER WIRE DOWN, HE PUT THE 6X120 ZPTX TO COVER ISR TOWARD THE DISTAL SFA. A FEW CLICKS AND THE RETRACTABLE SHEATH QUIT MOVING. HE REMOVED THE VIPER AND PLACED AN 0.035 DOWN, REMOVED THE PARTIALLY DEPLOYED ZPTX IN ITS ENTIRETY, AND UTILIZED A DCB INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7302224 ↗