Zilver PTX G38490Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10827002384900), received between Jun 3, 2016 and Apr 17, 2025 — classified as 13 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (13 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 08-JUL-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857652 ↗
• MalfunctionJan 25, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA PHONE: A 60 YEAR OLD MALE PATIENT UNDERWENT A STENTING OF THE SFA PROCEDURE IN WHICH THE ZILVER PTX 35 DRUG-ELUTING STENT. G38490, WAS USED. IT WAS NOTED THE PATIENT HAD A VERY TIGHT BIFURCATION AND THE DEVICE WAS HARD TO DO UP AND OVER AND THEN INTO POSITION. THE PHYSICIAN STARTED DEPLOYING AND THE DEVICE BROKE AFTER 30MM OF DEPLOYMENT. THE DISTRICT MANAGER AND PHYSICIAN BROKE OPEN THE HANDLE TO DEPLOY AND THE HANDLE BROKE. EVENTUALLY WAS ABLE TO DEPLOY THE STENT BUT THE STENT WAS ELONGATED ABOUT 200 MM AND DEFORMED. THE STENT WAS LEFT IN THE PATIENT AND THE PHYSICIAN DEPLOYED A LIFESTENT 6X150 INSIDE THE ZILVER TO OPEN UP THE ZILVER. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342692 ↗
• MalfunctionDec 4, 2020Failure to Advance; Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Failure to Advance; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE INVESTIGATION BEING COMPLETED ON 30-APR-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10945352 ↗
• MalfunctionDec 24, 2019Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PER COMPLAINT EMAIL: ANTEGRADE STICK TO THE LEFT LEG USING A 6FR 10CM SHEATH (COMPANY NOT SPECIFIED). FROM DISTAL TO PROXIMAL THE FOLLOWING STENTS WERE PLACED IN THE SFA: 6X100, 6X140, 7X140, 7X120, 7X60. THE THREE STENTS IN THE MIDDLE (6X140, 7X140, 7X120) ALL DID NOT DEPLOY CORRECTLY. IN THE IMAGE, THE STENTS LOOKED LIKE THEY WERE CRUNCHED UP AND NOT FULLY DEPLOYED. HOWEVER BOTH OF THE STENTS DISTAL AND PROXIMAL DEPLOYED JUST FINE. THERE WERE ALL DEPLOYED IN THE LEFT SFA. THE PATIENT DID NOT HAVE ANY FURTHER COMPLICATIONS OR ANY LONGER OF HOSPITAL STAY, THE OUTCOME LOOKED FINE EXCEPT HE HAD TO USE 5 STENTS INSTEAD OF 3. G38490 ¿ 7X120 LOT: C1547234 [PR286445]. G38483 ¿ 6X140 LOT: C1657393 [PR286450]. G38491 ¿ 7X140 LOT: C1577799 [PR286451]. 1. ARE IMAGES OF THE DEVICE OF PROCEDURE AVAILABLE? REP TOOK SOME PHOTOS ON PHONE, WILL TRY TO GET SENT IF MORE NEEDED. 2. WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? CONTRALATERAL. 3. IF CONTRALATERAL, WAS THE BIFURCATION ANGLE TIGHT? NO. 4. WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? YES. 5. WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? YES. 6. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)?

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9516324 ↗
• InjuryDec 11, 2019Material Twisted/Bent; Material Twisted/Bent

  REPORTED BY THE DM VIA COMPLAINT COMMUNICATION FORM- THE STENT WOULD ONLY DEPLOY ABOUT 2/3 AND THE THUMBWHEEL WOULD NOT COMPLETELY DEPLOY THE STENT. THEY HAD TO BREAK UP THE WHITE CARTRIDGE AND MANUALLY DELIVER THE STENT BY MANIPULATING THE WIRE/CATHETER. THE STENT WAS SOMEWHAT "SCRUNCHED" AND THEY LINED IT WITH VIABAHN. POST ARTERIALGRAM SHOWED A PATENT VESSEL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9450634 ↗
• InjuryNov 21, 2019Mechanical Jam; Mechanical Jam

  ACCORDING TO THE INITIAL REPORTER- THE STENT WOULD ONLY DEPLOY ABOUT 2/3 AND THE THUMBWHEEL WOULD NOT COMPLETELY DEPLOY THE STENT. THEY HAD TO BREAK UP THE WHITE CARTRIDGE AND MANUALLY DELIVER THE STENT BY MANIPULATING THE WIRE/CATHETER. THE STENT WAS SOMEWHAT "SCRUNCHED" AND THEY LINED IT WITH ANOTHER MANUFACTURER'S STENT. POST ARTERIALGRAM SHOWED A PATENT VESSEL. NO ADDITIONAL PROCEDURES WERE REQUIRED.

  Patient problems: No Information

  MAUDE report 9355623 ↗
• MalfunctionApr 1, 2019Off-Label Use; Off-Label Use

  AS REPORTED TO CUSTOMER RELATIONS: "(B)(6) THE HANDLE BREAK DURING DEPLOYMENT. HE WAS ABLE TO DEPLOY THE STENT MANUALLY HOWEVER HE HAD TO TAKE THE HANDLE APART. THERE WAS NO HARM TO THE PATIENT. ZISV6-35-125-7-120-PTX; 7/120; LOT: C1429587; EXP: 10/11/2019; I HAVE THE DEVICE FOR YOU IF YOU¿D LIKE IT, CAN YOU SEND ME A REPLACEMENT".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8469018 ↗
• InjuryMar 6, 2019Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  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." FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. AFTER THE STENT FRACTURED AN ANGIOPLASTY WAS REQUIRED. ALSO REPORTABLE UNDER THE FOLLOWING PRECEDENCES: THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT STENT FRACTURE DEPLOYMENT DIFFICULTY RESULTING IN PARTIAL STENT DEPLOYMENT. THIS COMPLAINT REPORT DOES NOT MEET THE REQUIREMENTS OF AN ADVERSE REACTION/DEVICE DEFECT REPORT AS PER 21 CFR PART 814.82 (A)(9).

  Patient problems: Failure of Implant

  MAUDE report 8394415 ↗
• InjuryNov 6, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS: "FOLLOWING LASER ATHERECTOMY AND ANGIOPLASTY - ZILVER PTX 6MMX120MM PLACED IN DISTAL LEFT SFA - MALFUNCTIONING PRODUCT (7MMX120MM PTX) STENT WAS OVERLAPPED AT PROXIMAL END OF 6MMX120MM PTX STENT. DURING DEPLOYMENT OF 7X120, THE PROXIMAL/LAST APPROX. 10MM OF STENT DEPLOYMENT ENCOUNTERED LARGE AMOUNT OF RESISTANCE AND DEPLOYMENT THUMBWHEEL SYSTEM NO LONGER WAS DEPLOYING STENT - LAST 10MM OF STENT FRACTURED DURING ATTEMPT TO PULL BACK THUMBWHEEL DELIVERY SYSTEM IN EFFORT TO MANUALLY DEPLOY STENT. FOLLOWING FRACTURE - FRACTURED 10MM OF STENT WAS SNARED/CAPTURED AND PULLED BACK INTO LEFT EXTERNAL ILIAC IN SAFE STENTING AREA AND RE-LINED/OVERLAPPED WITH A NEW LARGER BARE METAL SELF-EXPANDING STENT. AN ADDITIONAL 7MMX120MM ZILVER PTX STENT WAS PLACED INSIDE FRACTURED 7X120 TO RELINE STENT AND AT THE AT THE PROXIMAL EDGE OF NEW 7X120 STENT, AN ADDITIONAL 7MMX40MM PTX STENT PLACED TO COVER OCCLUDED LEFT SFA DISEASED VESSEL/COMPLETE STENTING PROCEDURE. IN TOTAL 6X120+7X120+7X40 ALONG WITH FRACTURED 7X120 WERE PLACED IN PATIENTS SFA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8042993 ↗
• MalfunctionOct 31, 2018Mechanical Problem; Mechanical Problem

  AS REPORTED TO CUSTOMER RELATIONS "IT INITIALLY WENT IN AND WOULD NOT CROSS. THEY TOOK IT OUT AND IT BOUND ON THE WIRE ON THE WAY OUT. THEY GOT IT OUT. THEY TRIED TO PUT IT BACK IN AND THE WIRE WOULD NOT GO THROUGH THE SHAFT OF THE DELIVERY SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SIMILAR STENT".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8025050 ↗
• MalfunctionOct 2, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS, "WHEN THEY DEPLOYED IT, THE STENT STRETCHED OUT TO ABOUT 200MM IN LENGTH INSTEAD OF 120MM. THEY PLACED ANOTHER STENT OVER THE DEVICE." UPDATED COMPLAINT INFORMATION FROM THE DM: "WHEN DEPLOYING STENT, THE FIRST 40MM DEPLOYED NORMALLY, THEN A WIRE POPPED OUT WHERE THE THUMBWHEEL IS. HE HAD TO CRANK REALLY HARD AT THAT POINT AND THE STENT STARTED TO ELONGATE. HE ENDED UP LEAVING THE STENT AS IT WAS. THERE WAS NOT AN ADDITIONAL STENT PLACED" -(B)(4) 05SEPT2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7925218 ↗
• InjuryAug 29, 2018Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  REPORT IS BEING SUBMITTED AS IT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. ALSO REPORTABLE UNDER THE PRECEDENCE FOR "THUMBWHEEL MALFUNCTIONS" "DEPLOYMENT DIFFICULTY RESULTING IN PARTIAL STENT DEPLOYMENT" AND "STENT FRACTURE". "THEY HAD GOTTEN THE ZILVER PTX TO THE DEPLOYMENT SITE AT THE DISTAL END OF A PREVIOUS STENT. THE PHYSICIAN STARTED DEPLOYING THE STENT AND ONCE THE STENT WAS ABOUT HALF-WAY DEPLOYED, IT WOULD NOT DEPLOY ANY FURTHER BUT THE THUMBWHEEL KEPT SPINNING. THE PHYSICIAN THEN ATTEMPTED THE PIN AND PULL METHOD BUT WAS UNSUCCESSFUL. HE THEN TRIED PULLING THE ENTIRE SYSTEM OUT OF THE BODY AND THE DEPLOYED PORTION OF THE STENT FRACTURED AND REMAINED IN THE PATIENT. THE UNDEPLOYED PORTION REMAINED IN THE SYSTEM AND WAS PULLED OUT. THE PHYSICIAN THEN PLACED A NEW STENT INSIDE OF THE FRACTURED STENT AND COMPLETED THE PROCEDURE SUCCESSFULLY."

  Patient problems: No Consequences Or Impact To Patient; Thrombosis/Thrombus

  MAUDE report 7826169 ↗
• InjuryAug 24, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS: "DEPLOYMENT HANDLE STOPPED DEPLOYING. THUMBWHEEL TURNED FREELY, STOPPED DEPLOYING. UPON ATTEMPTED REMOVAL, DISTAL PORTION OF THE DEVICE BROKE OFF AND THE REST WAS REMOVED. ANOTHER STENT WAS USED TO COVER UP THE DISTAL PORTION THAT REMAINED. APPROXIMATELY 2CM DEPLOYED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812127 ↗
• InjuryAug 21, 2018Break; Activation, Positioning or Separation Problem; Material Deformation; Break; Activation, Positioning or Separation Problem; Material Deformation

  THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. ALSO REPORTABLE UNDER PRECEDENCE'S: STENT FRACTURE, THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT AND RETRACTION WIRE SEPARATES FROM STENT RETRACTION SHEATH. AS REPORTED TO CUSTOMER RELATIONS: "FIRST DEVICE (7X120) WAS DEPLOYED SUCCESSFULLY. SECOND DEVICE (7X120) DIDN'T DEPLOY CORRECTLY, AND THE 2ND STENT BROKE TRYING TO REMOVE THE DELIVERY DEVICE. THE DISTAL PORTION THAT BROKE WAS LEFT IN THE PATIENT'S SFA AND BALLOONED AGAINST THE ARTERIAL WALLS. EVERYTHING ELSE WAS ATTACHED TO THE DELIVERY DEVICE AND WAS REMOVED SUCCESSFULLY. A THIRD DEVICE (7X100, AS THEY DIDN'T HAVE ANY 7X120S LEFT) WAS USED SUCCESSFULLY TO COMPLETE". PER DM: "STARTED TO DEPLOY (2ND DEVICE), THUMBWHEEL KEPT SPINNING BUT WOULDN'T DEPLOY ANY FURTHER. WIRE INSIDE BROKE, COULDN'T DO "PIN AND PULL", PHYSICIAN TRIED TO RETRIEVE EVERYTHING AND THAT'S WHEN THE DISTAL PORTION BROKE OFF".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801597 ↗
• InjuryJul 5, 2018Delivery System Failure; Activation, Positioning or Separation Problem; Delivery System Failure; Activation, Positioning or Separation Problem

  THIS MDR IS BEING SUBMITTED DUE TO SERIOUS INJURY. THEY RETRIEVED IT USING MULTIPLE DEVICES (DEVICE SPLIT INTO MULTIPLE PIECES DURING REMOVAL) AND HAVING TO DO ANOTHER GROIN PUNCTURE. PROCEDURE WAS ABORTED." NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING AFTER THIS EVENT. AS REPORTED TO CUSTOMER RELATIONS: "DURING NORMAL DEPLOYMENT, ABOUT 1/3 OF THE WAY DEPLOYED, CUSTOMER HEARD A LOUD POPPING SOUND AND THE THUMBWHEEL STOPPED WORKING (SPINNING FREELY). THEY RETRIEVED IT USING MULTIPLE DEVICES (DEVICE SPLIT INTO MULTIPLE PIECES DURING REMOVAL) AND HAVING TO DO ANOTHER GROIN PUNCTURE. PROCEDURE WAS ABORTED."

  Patient problems: Foreign Body In Patient

  MAUDE report 7663546 ↗
• InjuryFeb 28, 2018Fracture; Fracture

  THIS INITIAL MDR IS BEING SUBMITTED DUE TO SERIOUS INJURY. THE PATIENT REQUIRED SURGICAL INTERVENTION. AS REPORTED TO CUSTOMER RELATIONS: " DURING AN AIF INTERVENTION PROCEDURE ON A MALE PATIENT THE ZILVER PTX 35 DRUG-ELUTING STENT (G38490) WAS USED. A 6X5 FR ANSEL SHEATH WAS ALSO USED. THE PHYSICIAN HAD BALLOON AND LASERED THE SFA. ADVANCED THE DEVICE INTO THE SFA AND DEPLOYED THE FIRST 20 MM AND IT WOULD NOT GO ANY FURTHER. THE PHYSICIAN WAS STILL TURNING THE THUMB WHEEL AND THE STENT WOULD NOT ADVANCE. PULLED BACK SLIGHTLY ON STENT AND TRIED THE THUMBWHEEL BUT ONLY ELONGATED THE STENT. THE PHYSICIAN TOOK THE HANDLE APART TO MANUALLY DEPLOY BY PULLING BACK ON THE WIRE BUT THE WIRE WAS ALREADY BROKE. WHILE REMOVING THE PART OF DEPLOYED STENT APPROXIMATELY 10 MM OF STENT BROKE OFF IN THE PATIENT OVER THE FEMORAL HEAD. THE PHYSICIAN REMOVED EVERYTHING ELSE OF THE DEVICE. THEN WENT IN WITH A 7X80 R35 LP BALLOON AND BALLOON THE STENT UP AGAINST THE WALL. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED 3 FURTHER STENTS. ONE STENT WAS CONFIRMED TO BE COVERING THE 10 MM FRAGMENT OF STENT SECURELY. NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES REQUIRED."

  Patient problems: Foreign Body In Patient

  MAUDE report 7303306 ↗
• MalfunctionFeb 13, 2018Fracture; Delivery System Failure; Fracture; Delivery System Failure

  THERE WERE 5 PREVIOUS STENTS PLACED IN LEFT LEG FROM ILIAC TO SFA. WE WERE DEPLOYING THE LAST DEVICE AND THE THUMBWHEEL STOPPED DEPLOYING HALF WAY THROUGH THE STENT DEPLOYMENT. WE TOOK THE HANDLE APART AND TRIED TO FINISH DEPLOYMENT BUT WAS UNSUCCESSFUL. PHYSICIAN PULLED DELIVERY DEVICE AND DEPLOYED SOME MORE BUT BROKE IN TWO. PART OF THE STENT STAYED IN THE DELIVERY SYSTEM AND WAS PULLED OUT. THEY USED ANOTHER OF THE SAME DEVICE, REWIRED IT, AND SUCCESSFULLY DEPLOYED INSIDE OF THE PARTIALLY DEPLOYED STENT. ACCESS WAS LEFT BRACHIAL APPROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7265988 ↗
• InjuryJan 31, 2018Fracture; Delivery System Failure; Activation, Positioning or Separation Problem; Fracture; Delivery System Failure; Activation, Positioning or Separation Problem

  DURING DEPLOYMENT OF A G38490-ZISV6-35-125-7-120-PTX (LOT# C1421608), THE DEPLOYMENT MECHANISM FAILED AND THE DEVICE WOULD NOT DEPLOY. THE DISTAL SEVERAL CENTIMETERS OF THE STENT SHEARED OFF. A CUT DOWN WAS PERFORMED TO FULLY REMOVE THE PORTION OF THE STENT. AFTER THIS DIFFICULTY WAS EXPERIENCED, A G38482-ZISV6-35-125-6-120-PTX WAS PULLED FOR USE AND THE DEVICE DID FLUSH AS INTENDED. THE DEVICE WAS USED AND THERE WAS SOME DIFFICULTY ENCOUNTERED; HOWEVER THE DEVICE WAS SUCCESSFULLY DEPLOYED AND PLACED AS INTENDED IN THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 7230429 ↗
• 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 # 3001845648-2017-00574.

  Patient problems: Pain

  MAUDE report 7070514 ↗
• 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 6943506 ↗
• MalfunctionJun 16, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE FACILITY WAS STENTING THE ENTIRE SFA AND THEY SUCCESSFULLY PUT TWO OTHER STENTS (7X120 PTX) IN THE PATIENT. THE PHYSICIAN WENT TO DEPLOY THE THIRD STENT AND THE THUMBWHEEL BROKE. THIS THIRD STENT WAS NOT FULLY DEPLOYED AND THE PHYSICIAN WAS UNSURE HOW TO PROCEED. THE PHYSICIAN ENDED UP TAKING APART THE HANDLE OF THE THUMBWHEEL AND WAS ABLE TO GET THE DEVICE TO DEPLOY. THE PHYSICIAN WAS ABLE TO CONTINUE THE PROCEDURE WITH THE COMPLAINT DEVICE AND COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6646061 ↗
• MalfunctionMay 2, 2017Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  THE PHYSICIAN DELIVERED A DISTAL PTX STENT. UPON DELIVERING THE COMPLAINT DEVICE TO OVERLAP, THE PHYSICIAN NOTED HAVING A DIFFICULT TIME CROSSING THE LESION AND UPON TURNING THE THUMB WHEEL, IT WAS VERY TOUGH. ONCE THE COMPLAINT DEVICE WAS DEPLOYED APPROXIMATELY 2CM, THE THUMB WHEEL WAS ROTATING WITHOUT RESPONSE AND THE STENT WOULD NOT DEPLOY ANY FURTHER. THE STENT COULD NOT BE PULLED BACK, SO THE PHYSICIAN ADVANCED THE SHEATH OVER THE STENT TO ATTEMPT TO RECAPTURE, BUT THE ENTIRE STENT COULD NOT BE RECAPTURED. UPON REMOVING THE COMPLAINT DEVICE WHICH WAS PARTIALLY RECAPTURED, THE DISTAL END OF THE COMPLAINT DEVICE FRACTURED AND WAS LEFT INSIDE THE DISTAL PTX. THE FRACTURED PORTION OF THE DEVICE REMAINED IN THE DISTAL STENT, AND AN ABBOT SUPERA STENT WAS DEPLOYED INSIDE THE DISTAL PTX AND FRACTURED PORTION OF THE COMPLAINT DEVICE, ESSENTIALLY TRAPPING THE FRACTURED PORTION INTO PLACE.

  Patient problems: No Code Available

  MAUDE report 6536370 ↗
• InjuryJun 3, 2016Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS BY THE REP WHO ATTENDED THE CASE: WE WERE IN WITH A 6FR 45CM ANSEL 0 SHEATH AND A HYDRO ST WIRE. WE FIRST BALLOONED WITH A 4X20CM 14LP. THERE WERE A FEW REALLY TIGHT PLACES. NEXT, WE UPSIZED AND BALLOONED WITH A 6X20CM 18LP. STILL, THERE WERE A FEW REALLY TIGHT LESIONS. HOWEVER, THEY SEEMED TO GIVE ONCE BALLOONED. THEN WE REMOVED THE BALLOON AND WENT IN WITH A 7X120 ZILVER PTX STENT AND PLACED IT DISTALLY, THROUGH THE HUNTERS CANAL. NEXT, HE ENTERED THE SHEATH, OVER THE HYDRO ST 300CM WIRE WITH ANOTHER 7X120MM ZILVER PTX STENT (THIS REPORT 3001845648-2016-00147). HE ADVANCED THE DELIVERY SYSTEM PAST THE LESIONS AND INTO THE PROXIMAL PORTION OF THE FIRST STENT HE PLACED. HE PRESSED THE SAFETY BUTTON AND BEGAN CLICKING THE THUMBWHEEL. CLOSE TO ¼ OF THE STENT WAS DEPLOYED WHEN HE STARTED FEELING A LOT OF RESISTANCE. HE CONTINUED TO TRY AND ROLL THE THUMBWHEEL. THEN HE HEARD A "POP." AT THAT POINT, THE THUMBWHEEL WOULD CLICK BUT THE STENT WOULD NOT CONTINUE TO DEPLOY LEAVING IT PARTIALLY DEPLOYED IN THE SYSTEM. HE TRIED PULLING BACK TENSION ON THE DELIVERY SYSTEM. HOWEVER, IT WOULDN'T BUDGE. AS HE USED MORE FORCE THE ENTIRE PARTIALLY DEPLOYED STENT POR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5697163 ↗