Zilver PTX G38483Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10827002384832), received between Jun 21, 2018 and Mar 19, 2026 — classified as 7 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (9 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Improper or Incorrect Procedure or Method

  THE PHYSICIAN WAS DOING A LEFT LOWER EXTREMITY ANGIOGRAM; PATIENTS ANATOMY WAS CALCIFIED. THE DEVICE WAS INTRODUCED INTO THE BODY THEN THE DEVICE ENDED UP KINKING. IT WAS NOT ABLE TO PASS OVER THE BIFURCATION TO TREAT. THEY WERE ABLE TO OPEN ANOTHER G38483 TO FINISH THE PROCEDURE. IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? STEEP CALIFIED BIFURCATION. WHAT WAS THE ACCESS SITE CHOSEN? LEFT COMMON FEM. DETAILS OF THE ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 6FR 45CM TERUMO DESTINATION DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? 014 SPIDER FILTER WIRE. WHAT APPROACH WAS USED TO ACCESS THE TARGET SITE? CONTRALATERAL. WHAT WAS THE TARGET LOCATION FOR THE STENT? MID SFA. WHAT ARTERY WAS THE STENT PLACED IN? MID SFA. WAS THE PATIENT'S ANATOMY DIFFICULT OR ALTERED? CALCIFED. WHAT INTERVENTION (IF ANY) WAS REQUIRED? NONE. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? NO. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN? NO. CAN AN ADDITIONAL QUESTION BE ASKED TO CONFIRM IS THE KINK WAS OBSERVED ON THE CATHETER OR WAS IT ON THE STE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642611 ↗
• MalfunctionMar 16, 2026Improper or Incorrect Procedure or Method

  PER REP - ON (B)(6) 2026 - WHEN THEY WERE ADVANCING IT OVER THE WIRE, THE CATHETER PART OF IT KINKED. THEY REMOVED IT AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE OF THE SAME TYPE. WHAT DISEASE PATHOLOGY WAS BEING TREATED? CALCIUM. IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? YES, NOT STEEP. WHAT WAS THE ACCESS SITE CHOSEN? RIGHT GROIN. DETAILS OF THE ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 6 FR X 45 CM COOK ANSEL SHEATH. WERE THERE ANY ISSUES WITH FLUSHING OF THE DEVICE? N/A, YES, NO, NO. DETAILS OF THE ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 6 FR X 45 CM COOK ANSEL SHEATH. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? .014 WIRE. 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) CONTRALATERAL. WHAT WAS THE TARGET LOCATION FOR THE STENT? MID SFA. 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) NOT DEPLOYED. WHAT DISEASE PATHOLOGY WAS BEING TREATED? CALCIUM. DID THE STENT DELIVERY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604161 ↗
• MalfunctionMar 28, 2025Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  A ZILVER PTX WAS BEING USED. AT SOME POINT ABOUT A THIRD OF THE STENT WAS DEPLOYED, BUT THE REST OF THE STENT WOULD NOT DEPLOY. THE SIZE IS UNKNOWN. THE DOCTOR TRIED TO BREAK OPEN THE HANDLE TO GET THE STENT TO DEPLOY, BUT IT DID NOT WORK. THE DEVICE WAS REMOVED ALTOGETHER. A STENT WAS EVENTUALLY DEPLOYED MANUALLY. THERE ALSO WAS ANOTHER DEVICE THAT THE CUSTOMER TRIED TO USE DURING THE PROCEDURE BEFORE THE STENT WAS MANUALLY DEPLOYED. PATIENT IS FINE, NO PATIENT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717934 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO CUSTOMER RELATIONS: ON THURSDAY AFTERNOON (B)(6) I SUPPORTED HER ANGIO AND LOWER EXTREMITY INTERVENTION WHERE SHE DEPLOYED FOUR ZILVER PTX STENTS IN AN SFA (TWO 7X140 PTX STENTS G38491 AND ONE 7X60 STENT G38487 IN PROXIMAL SFA ALONG WITH ONE 6X140 PTX STENT G38483) IN DISTAL SFA. AFTER POST DILATING WITH A 5X220 MUSTANG BALLOON, DOCTOR WAS PLEASED WITH THE FINAL RUN IMAGING (SEE ATTACHED). HOWEVER, SHE LET US KNOW YESTERDAY AFTERNOON THAT THE PATIENT THROMBOSED, POSSIBLY WITHIN THE STENTED SEGMENT. DR (B)(6) SAID IT¿S STRANGE THAT THE STENTS THROMBOSED BECAUSE HER REST PAIN WAS HEALED, AND SHE FEELS A LOT BETTER. THEY LOADED PLAVIX IN RECOVERY, AND SHE HAD BEEN ON ASA PRIOR TO THE CASE, SO THERE WAS NO LAPSE IN ANTI-PLATELET THERAPY. THEY JUST GOT A DUPLEX ULTRASOUND IN FOLLOW UP SO SHE¿S BRINGING THE PATIENT IN LATER TODAY FOR EITHER THROMBECTOMY OR BYPASS, BASED ON WHAT IS FOUND UNDER FLUORO. SHE BELIEVES THE LONG-STENTED SEGMENT, COMBINED WITH UNTREATED HYPOTENSION COULD BE THE SOURCE OF THE THROMBOSIS. SHE ALSO EXPRESSED CONCERNS OVER POTENTIAL FOR THUMBWHEEL DEPLOYMENT STENTS TO JUMP AND PREFERS PIN-AND-PULL FOR MORE PRECISION. THE PATIENT THROMBOSED, POSSIBLY W

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21702237 ↗
• MalfunctionJul 16, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  DESCRIPTION OF EVENT: PER REP - (B)(6) 2024 - THE DISTAL TIP OF THE DEPLOYMENT DEVICE SEPARATED FROM THE REST OF THE DEPLOYMENT DEVICE. THEY SAID THAT THE STENT DEPLOYED SUCCESSFULLY. WHEN THEY TRIED TO REMOVE THE DEPLOYMENT SYSTEM THE FROM SHEATH, IT GOT STUCK AND EVENTUALLY SEPARATED INSIDE SHEATH. IT WAS ALL REMOVED WITH THE SHEATH. THE PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. 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 -YES 3.61 WAS THE DEVICE FLUSHED BEFORE THE PROCEDURE, AS PER IFU? N/A, YES, NO -YES 3.62 WERE THERE ANY ISSUES WITH FLUSHING OF THE DEVICE? N/A, YES, NO -NO 3.63 DETAILS OF THE ACCESS SHEATH USED (NAME, FR SIZE,LENGTH)? -UNKR 3.64 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILLIC)? -UNKR, NOT HYDROPHYLIC 3.65 WHAT APPROACH WAS USED TO ACCESS THE TARGET SITE? CONTRALATERAL, IPSILATERAL, ANTEGRADE, RETROGRADE, OTHER -UNKR 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? -SFA 3.67 WHAT ARTERY WAS THE STENT PLACED IN? PROXIMAL SF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19748484 ↗
• MalfunctionMar 19, 2024Activation Failure; Activation Problem; Activation Failure; Activation Problem

  FOLLOWING DEPLOYMENT OF THE STENT, THERE WAS A FINDING OF A POTENTIAL FOLDING OR UNDER EXPANDED PORTION ON DISTAL END OF STENT (STENT EDGE UNDER DEPLOYED). ANGIOPLASTY WITH BALLOONING WAS PERFORMED BUT WAS UNSUCCESSFUL IN CORRECTING THE UNDER DEPLOYMENT. A BARE METAL STENT WAS PLACED TO OVERLAP AND KEEP THE STENT OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18929066 ↗
• MalfunctionJul 28, 2023Dent in Material; Physical Resistance/Sticking; Dent in Material; Physical Resistance/Sticking

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 19-JAN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412444 ↗
• MalfunctionApr 25, 2023Structural Problem; Structural Problem

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS ON THE 14-AUG-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805606 ↗
• MalfunctionOct 13, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PER REP - (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. 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 3.62 WERE THERE ANY ISSUES WITH FLUSHING O

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

  MAUDE report 15596481 ↗
• MalfunctionOct 13, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PER REP (B)(4) THE CUSTOMER STATED THAT THE PATIENT CAME BACK IN WITH INDURATED SKIN LESIONS. THEY WONDER IF THE PACLITAXEL MIGHT BE RESPONSIBLE FOR THIS. 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 DUE TO THIS OCCURRENCE? -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 OCCURRENCE? -POSSIBLY. 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. PREFIX ZIV6-PTX/ZISV6-PTX: ARE IMAGES (E.G. ANGIOGRAPHY, US ETC.) OF THE DEVICE AND/OR PROCEDURE AVAILABLE? N/A, YES, NO -NO. 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 ACCESS SHEATH USED (NAME, FR

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

  MAUDE report 15596305 ↗
• InjuryOct 11, 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 15581372 ↗
• InjuryOct 11, 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 15581324 ↗
• MalfunctionAug 25, 2022Improper or Incorrect Procedure or Method; Dent in Material; Improper or Incorrect Procedure or Method; Dent in Material

  AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "THE STENT WAS A LITTLE UNDER EXPANDED AFTER DEPLOYMENT. THE PHYSICIAN INDICATED THE WIRE WAS BENT AND HE HAD TO ADVANCE AND RETRACT THE DELIVERY SYSTEM. THE PHYSICIAN STATED IT APPEARS THE STRUT ON THE STENT IS BENT. THEREFORE, ANOTHER PTX WAS DEPLOYED ACROSS THE PROXIMAL PORTION OF THE STENT. NOTE: PER DM, IT'S NOT CLEAR (WHEN THE PHYSICIAN WAS ADVANCING AND RETRACTING THE DELIVERY SYSTEM )- IF THIS CAUSED THE STRUT TO BEND. 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 DUE TO THIS OCCURRENCE? - NOTHING REPORTED TO THE DM 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 OCCURRENCE? - NO HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? - NO · PLEASE SPECIFY ADVERSE EFFECTS AND PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292782 ↗
• MalfunctionJul 8, 2021Positioning Failure; Difficult to Remove; Positioning Failure; Difficult to Remove

  WOULDN¿T CROSS-GOT STUCK ON WIRE-NOT SURE WIRE USED. PATIENT OUTCOME: THE REP HAS BEEN ASKED TO PROVIDE THE ANSWERS TO THE FOLLOWING QUESTIONS. 15JUN2021 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 OCCURRENCE? -NO HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? -NO PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. THE REP HAS BEEN ASKED TO PROVIDE THE ANSWERS TO THE FOLLOWING QUESTIONS.15JUN2021 ARE IMAGES (E.G. ANGIOGRAPHY, US ETC.) OF THE DEVICE AND/OR PROCEDURE AVAILABLE? N/A, YES, NO NO 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 ACCESS SHEATH USED (NAME, FR SIZE,LENGTH)? 6-

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133206 ↗
• MalfunctionNov 17, 2020Off-Label Use; Off-Label Use

  THEY WERE DOING A RETROGRADE ACCESS OF THE ANTERIOR TIBIAL ARTERY. THEY PUT IT UP TO THE TIBIAL AND THE VESSEL SPASMED AND IT GOT STUCK. USER GAVE NITRO, WAITED A FEW MINUTES AND THEN PULLED IT OUT. DEVICE WAS NOT DEPLOYED. USER ABORTED THE PROCEDURE DO TO OTHER UNRELATED ISSUES. 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 DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. 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 OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. WHERE WAS THE ACCESS SITE? ANTERIOR TIBIAL. WHAT WAS THE PATIENT¿S ANATOMY? I.E. SCARRED, TORTUOUS, CALCIFIED, ETC. ASKU. WHAT WAS THE TARGET LOCATION FOR THE STENT? DISTAL SFA. WAS THE TARGET LOCATION SEVE

  Patient problems: Cramp(s) /Muscle Spasm(s); Muscle Spasm(s); Vasoconstriction

  MAUDE report 10849869 ↗
• MalfunctionOct 15, 2020Structural Problem; Activation Problem; Structural Problem; Activation Problem

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

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

  MAUDE report 10683031 ↗
• MalfunctionAug 25, 2020Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED TO DOCUMENT RECEIPT OF IMAGE REVIEW.

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

  MAUDE report 10447365 ↗
• InjuryApr 24, 2020Off-Label Use; Off-Label Use

  FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: PER DM VIA PHONE: 65 YEAR OLD MALE PATIENT PRESENTED WITH COLD LEG AND WAS ADMITTED TO THE FACILITY (DATE ADMITTED UNKNOWN ¿ (B)(6) 2020). THE PATIENT WAS KEPT ON HEPARIN DRIP UNTIL FRIDAY (B)(6) 2020. DURING A CALL BETWEEN THE DM AND PHYSICIAN ON FRIDAY (B)(6) 2020, THE DM MADE IT CLEAR TO THE PHYSICIAN, THAT PHYSICIAN¿S PLAN TO PLACE THE STENT IN THE DISTAL SFA/PROXIMAL POPLITEAL (RIGHT LEG) WAS OFF LABEL USE OF THE DEVICE; THE PHYSICIAN PREFERRED TO PROCEED WITH TREATMENT AS PLANNED. ON FRIDAY (B)(6) 2020, THROMBOLYSIS WAS PERFORMED; PATIENT KEPT ON THROMBOLYSIS TREATMENT UNTIL SATURDAY (B)(6) 2020. THE DM DELIVERED THE DEVICE TO THE PHYSICIAN AND WAS PRESENT FOR THE CASE ON (B)(6) 2020. THE CASE AND DEVICE PLACEMENT IN THE DISTAL SFA/PROXIMAL POPLITEAL PROCEEDED AND WAS SUCCESSFUL, CONFIRMING BLOOD FLOW TO THE FOOT. THE PATIENT WAS SENT UPSTAIRS. THE DM WAS IN CONTACT WITH THE PHYSICIAN TO KEEP UP TO DATE ON THE PATIENT¿S STATUS. UPON SPEAKING TO THE PHYSICIAN ON SUNDAY (B)(6) 2020, THE DM WAS MADE AWARE THAT THE PATIENT HAD EXPIRED SOMETIME EARLY SUNDAY (B)

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9994893 ↗
• MalfunctionMar 26, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  COMPLAINT CALLED IN BY DM ON 28FEB2020--DID 28FEB2020. AS REPORTED TO CUSTOMER RELATIONS: "DEVICE DID NOT DEPLOY. NO OTHER DETAILS PROVIDED." ADDITIONAL INFORMATION PROVIDED BY DM ON (B)(6) 2020: HOW WAS THE PROCEDURE COMPLETED? NEW PTX OPENED AND USED".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9883936 ↗
• MalfunctionDec 24, 2019Material Deformation; 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 [(B)(4)]. G38483 ¿ 6X140 LOT C1657393 [(B)(4)]. G38491 ¿ 7X140 LOT C1577799 [(B)(4)]. 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)? BENTSON, 035 7

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

  MAUDE report 9516325 ↗
• MalfunctionSep 11, 2019Difficult to Remove; Difficult to Remove

  AFTER DEPLOYING THE STENT SUCCESSFULLY, THE DELIVERY DEVICE GOT STUCK ON THE 0.035 BENTSON WIRE. THE WIRE AND DELIVERY SYSTEM WERE REMOVED TOGETHER AND A NEW WIRE WAS INTRODUCED TO COMPLETE THE PROCEDURE. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DELIVERY SYSTEM CANNOT BE WITHDRAWN¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8992559 ↗
• MalfunctionApr 25, 2019Positioning Problem; Positioning Problem

  AS REPORTED TO CUSTOMER RELATIONS "THE WIRE WAS IN. IT HAD CROSSED THE LESION. AS THEY WERE ADVANCING THE STENT OVER THE WIRE, THE STENT WAS STICKING. THE WIRE GUIDE WAS A CORDIS AQUATRACK GLIDE WIRE. WHEN THEY WENT TO REMOVE THE STENT OFF THE WIRE, THE WIRE WAS STUCK IN THE STENT. THEY COULD NOT REMOVE THE STENT FROM THE WIRE. THEY HAD TO PULL THE STENT AND WIRE FROM THE PATIENT. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH A NEW WIRE AND STENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8548219 ↗
• MalfunctionApr 16, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS, "PHYSICIAN WAS ADVANCING THE PTX CATHETER AND THERE WAS RESISTANCE. THERE WAS TORTUOSITY AND CALCIFICATION PRESENT. PHYSICIAN STARTED DEPLOYING THE STENT AND THUMBWHEEL WAS VERY HARD TO MOVE. ALL OF A SUDDEN THE THUMBWHEEL CLICKED AND IT WAS LIKE THE STENT WAS FULLY DEPLOYED BUT IT WASN'T. THERE WAS STILL A PORTION OF THE STENT THAT WAS NOT DEPLOYED BUT THE THUMBWHEEL DID NOT WORK. THE PHYSICIAN SLOWLY PULLED THE DELIVERY CATHETER AND THE REMAINDER OF THE STENT WAS FULLY OUT OF THE DELIVERY CATHETER. THERE WAS A PORTION OF THE STENT THAT ELONGATED. PHYSICIAN DID A POST DILITATION AFTERWARDS. THE PATIENT WAS NOT HARMED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8517729 ↗
• 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. UPDATE PER DM ON 29JAN2019: "THE WIRE USED IN THE CASE WAS A TERUMO STIFF STRAIGHT GLIDE WIRE. I HAVE NOT BEEN ABLE TO GET IMAGING OF THE STENTS. AFTER STENT DEPLOYMENT THERE WAS NO FLOW, I ASKED THE PHYSICIAN IF THEY THOUGHT IT WAS RELATED TO THE STENTS AND THEY SAID NO."

  Patient problems: Disability; Hypovolemia

  MAUDE report 8339304 ↗
• MalfunctionFeb 12, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PHYSICIAN WAS REALIGNING EXISTING STENTS AND DEPLOYING THE COOK STENT. AT APPROXIMATELY 70% DEPLOYMENT, THE USER FELT IT GOT TIGHT AND MIGHT SNAP. THE DEPLOYMENT WENT WELL AFTER COMMUNICATING WITH THE HEAD OF PAD THERAPIES AT COOK AND ENGINEERING PERSONNEL. INSTEAD OF USING THE WHEEL THE SYSTEM WAS PULLED BACK TO BE ABLE TO FULLY DEPLOY THE STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8330201 ↗