Zilver PTXRecalls & reported problems across all models

We found 28 models of Zilver PTX by Cook Ireland Ltd in the FDA's device registry (GUDID). Together they are named in 302 adverse event reports in the FDA's MAUDE database, received between Oct 30, 2014 and Apr 3, 2026 — classified as 138 injuries, 164 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (75 reports).

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Zilver PTX recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 18, 2013Terminated

   Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation

   Z-1275-2013 · Root cause: Process control · Recall details · FDA record ↗

2. Apr 18, 2013Terminated

   Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation

   Z-1274-2013 · Root cause: Process control · Recall details · FDA record ↗

Most reported Zilver PTX problems

Zilver PTX models

28 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Zilver PTX G24890

  Stent, superficial femoral artery, drug-eluting
  1 recall24 reports
• Zilver PTX G38482

  Stent, superficial femoral artery, drug-eluting
  57 reports
• Zilver PTX G24895

  Stent, superficial femoral artery, drug-eluting
  1 recall3 reports
• Zilver PTX G38483

  Stent, superficial femoral artery, drug-eluting
  32 reports
• Zilver PTX G38490

  Stent, superficial femoral artery, drug-eluting
  23 reports
• Zilver PTX G24888

  Stent, superficial femoral artery, drug-eluting
  20 reports
• Zilver PTX G38481

  Stent, superficial femoral artery, drug-eluting
  16 reports
• Zilver PTX G38480

  Stent, superficial femoral artery, drug-eluting
  14 reports
• Zilver PTX G38488

  Stent, superficial femoral artery, drug-eluting
  14 reports
• Zilver PTX G38489

  Stent, superficial femoral artery, drug-eluting
  14 reports
• Zilver PTX G38491

  Stent, superficial femoral artery, drug-eluting
  11 reports
• Zilver PTX G24935

  Stent, superficial femoral artery, drug-eluting
  10 reports
• Zilver PTX G38479

  Stent, superficial femoral artery, drug-eluting
  10 reports
• Zilver PTX G38463

  Stent, superficial femoral artery, drug-eluting
  8 reports
• Zilver PTX G38416

  Stent, superficial femoral artery, drug-eluting
  6 reports
• Zilver PTX G38487

  Stent, superficial femoral artery, drug-eluting
  6 reports
• Zilver PTX G24894

  Stent, superficial femoral artery, drug-eluting
  5 reports
• Zilver PTX G38486

  Stent, superficial femoral artery, drug-eluting
  5 reports
• Zilver PTX G38516

  Stent, superficial femoral artery, drug-eluting
  5 reports
• Zilver PTX G38407

  Stent, superficial femoral artery, drug-eluting
  4 reports
• Zilver PTX G24937

  Stent, superficial femoral artery, drug-eluting
  3 reports
• Zilver PTX G38532

  Stent, superficial femoral artery, drug-eluting
  3 reports
• Zilver PTX G24889

  Stent, superficial femoral artery, drug-eluting
  2 reports
• Zilver PTX G38415

  Stent, superficial femoral artery, drug-eluting
  2 reports
• Zilver PTX G38495

  Stent, superficial femoral artery, drug-eluting
  2 reports
• Zilver PTX G34314

  Stent, superficial femoral artery, drug-eluting
  1 report
• Zilver PTX G24891

  Stent, superficial femoral artery, drug-eluting
  1 report
• Zilver PTX G38518

  Stent, superficial femoral artery, drug-eluting
  1 report

Recent Zilver PTX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Improper or Incorrect Procedure or Method

  THE SHAFT WAS KINKED AND THEY WERE NOT ABLE TO ADVANCE A .018 WIRE TO EXIT THE TIP. THEY HAD TO USE ANOTHER G38481 TO FINISH THE PROCEDURE. IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? DID NOT GET INTO THE PATIENT, TRIED TO LOAD THE .018¿ WIRE THROUGH THE ZILVER PTX 6 MM X 100 MM OUTSIDE OF BODY WOULDN'T ADVANCE, THERE WAS A KINK IN SHAFT THE DRS. TRIED TO STRAIGHTEN IT OUT WITH FORCEPS. WHAT WAS THE ACCESS SITE CHOSEN? COMMON FEMORAL. DETAILS OF THE ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? RAABE 6 FR X 55 CM. WHAT APPROACH WAS USED TO ACCESS THE TARGET SITE? CONTRALATERAL, NO. WHAT WAS THE TARGET LOCATION FOR THE STENT? SFA, STENT DID NOT ENTER VASCULAR. WHAT ARTERY WAS THE STENT PLACED IN? PROXIMAL SFA TO PROXIMAL POPLITEAL. ANOTHER ZILVER PTX 6 MM X 100 MM WAS PLACED NOT THE KINKED SHAFT ONE. IT WAS ALSO FROM THE SAME LOT NUMBER. WHAT DISEASE PATHOLOGY WAS BEING TREATED? MIXED PLAQUE. DID THE STENT DELIVERY SYSTEM CROSS THE TARGET LOCATION? NO, USED ANOTHER ZILVER PTX STENT- 6 MM X 100 MM THAT CROSSED USING THE SAME .018¿ WIRE WHAT WAS THE ACCESS SITE CHOSEN? COMMON FEMORAL HAD NO BARING ON THE WIRE INITIALING NOT PASSING THROUGH THE WIRE LUMEN OF STENT. WAS THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24774894 ↗
• 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 3, 2026Improper or Incorrect Procedure or Method

  AS REPORTED VIA EMAIL: "ONE OF MY PHYSICIANS USED ZILVER PTX DURING A PROCEDURE LAST WEEK, AND THE STENT MOVED DURING DEPLOYMENT. THE PHYSICIAN IS A VASCULAR SURGEON WHO IS NOT VERY EXPERIENCED WITH ENDOVASCULAR PROCEDURES. IT WAS HIS FIRST TIME USING ZILVER PTX. AN INTEGRATED ACCESS APPROACH WAS DONE. THE PATIENT WAS ELDERLY AND HAD SEVERE PERIPHERAL ARTERIAL DISEASE. CROSSING THE LESION WAS CHALLENGING, AS THE VESSEL WAS HIGHLY STENOTIC AND CALCIFIED. BECAUSE THE ACCESS WAS INTEGRATED AND POSITIONED ON THE OPPOSITE SIDE OF THE TABLE, THE DR WAS WORKING IN AN UP-AND-OVER POSITION BUT OUTSIDE OF THE PATIENT. AT THE TIME OF STENT DEPLOYMENT, THE SYSTEM WASN¿T STABILIZED PROPERLY AND THE STENT MOVED. AFTER DISCUSSION WITH COLLEAGUES, IT SEEMS THAT IT IS A USER ERROR." WHAT WAS THE DATE OF THE OCCURRENCE? FEBRUARY 2ND. WILL THE FACILITY BE REPORTING THIS TO A GOVERNMENT AGENCY (FDA, COMPETENT AUTHORITY, ETC.) NO. USAGE OF PRODUCT: INITIAL USE OF DEVICE. IS THE DEVICE AVAILABLE FOR RETURN? NO DID THE PATIENT REQUIRE ANY ADDITIONAL INTERVENTIONS/PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT? NO WERE BOTH OF THOSE DEVICES USED IN THE SAME PATIENT? YES WHAT WAS THE ACCESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495519 ↗
• MalfunctionJan 23, 2026Fracture; Improper or Incorrect Procedure or Method

  A SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE ON (B)(6) 2026 TO CAPTURE THE INVESTIGATION CONCLUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159857 ↗
• MalfunctionJan 23, 2026Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 19-MAR-26.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159708 ↗
• MalfunctionDec 10, 2025Failure to Advance; Deformation Due to Compressive Stress; Failure to Advance; Deformation Due to Compressive Stress

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 22-JAN-26.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768232 ↗
• InjuryAug 27, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PER REP - (B)(6) 2025 - THEY HAD ACCESS ON RIGHT SIDE OF THE PATIENT AND WERE OVER THE BIFURCATION ATTEMPTING TO STENT THE LEFT LEG. DURING DEPLOYMENT, ROUGHLY TWO THIRDS OF THE STENT DEPLOYED AND ONE THIRD WAS STUCK IN THE DEPLOYMENT SYSTEM. THEY ENDED UP BREAKING OPEN THE HANDLE OF THE PTX AND ATTEMPTING TO DEPLOY THE REST OF STENT. THEY WERE ABLE TO GET THE PROXIMAL ONE THIRD OF THE STENT DEPLOYED BUT IT WAS INSIDE OF THE INTRODUCER SHEATH THAT WAS OVER THE BIFURCATION. THE CASE IS STILL GOING ON. THEY ARE PRESENTLY ATTEMPTING TO EXTRACT THE REST OF THE STENT FROM THE SHEATH. UPDATE FROM REP - (B)(6) 2025 - FROM THE PHYSICIAN THE DEVICE FAILED TO FULLY DEPLOY, AND AS THEY WERE TRYING TO BACK IT OUT, WHILE PARTIALLY DEPLOYED, IT GOT STUCK ON THE AORTIC BIFURCATION AND THEN BECAME DETACHED FROM THE DELIVERY SYSTEM COMPLETELY. THEY ENDED UP HAVE TO USED 3 MORE DEVICES TO ANCHOR IT IN PLACE. PT IS DOING FINE. OUTSIDE OF A SOMEWHERE STEEP AORTIC BI-FUR, NOTHING WAS OUT OF THE ORDINARY. I HAVE THE FAILED DEVICE IN QUESTION, AS I STOPPED BY TO PICK IT UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904252 ↗
• 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 ↗
• InjuryJul 8, 2025Off-Label Use; Activation, Positioning or Separation Problem; Off-Label Use; Activation, Positioning or Separation Problem

  PER REP - 10JUN2025 - THEY HAD ACCESS ON RIGHT SIDE OF THE PATIENT AND WERE OVER THE BIFURCATION ATTEMPTING TO STENT THE LEFT LEG. DURING DEPLOYMENT, ROUGHLY TWO THIRDS OF THE STENT DEPLOYED AND ONE THIRD WAS STUCK IN THE DEPLOYMENT SYSTEM. THEY ENDED UP BREAKING OPEN THE HANDLE OF THE PTX AND ATTEMPTING TO DEPLOY THE REST OF STENT. THEY WERE ABLE TO GET THE PROXIMAL ONE THIRD OF THE STENT DEPLOYED BUT IT WAS INSIDE OF THE INTRODUCER SHEATH THAT WAS OVER THE BIFURCATION. THE CASE IS STILL GOING ON. THEY ARE PRESENTLY ATTEMPTING TO EXTRACT THE REST OF THE STENT FROM THE SHEATH. UPDATE FROM REP - 16JUN2025 - FROM THE PHYSICIAN THE DEVICE FAILED TO FULLY DEPLOY, AND AS THEY WERE TRYING TO BACK IT OUT, WHILE PARTIALLY DEPLOYED, IT GOT STUCK ON THE AORTIC BIFURCATION, AND THEN BECAME DETACHED FROM THE DELIVERY SYSTEM COMPLETELY. THEY ENDED UP HAVE TO USED 3 MORE DEVICES TO ANCHOR IT IN PLACE. PT IS DOING FINE. OUTSIDE OF A SOMEWHERE STEEP AORTIC BI-FUR, NOTHING WAS OUT OF THE ORDINARY. I HAVE THE FAILED DEVICE IN QUESTION, AS I STOPPED BY TO PICK IT UP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22453444 ↗
• InjuryJun 27, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ACCORDING TO THE INITIAL REPORTER, FROM THE PHYSICIAN THE DEVICE FAILED TO FULLY DEPLOY, AND AS THEY WERE TRYING TO BACK IT OUT, WHILE PARTIALLY DEPLOYED, IT GOT STUCK ON THE AORTIC BIFURCATION AND THEN BECAME DETACHED FROM THE DELIVERY SYSTEM COMPLETELY. THEY ENDED UP HAVE TO USED 3 MORE DEVICES TO ANCHOR IT IN PLACE. PT IS DOING FINE. OUTSIDE OF A SOMEWHERE STEEP AORTIC BI-FUR, NOTHING WAS OUT OF THE ORDINARY. I HAVE THE FAILED DEVICE IN QUESTION, AS I STOPPED BY TO PICK IT UP. FURTHER INFORMATION PROVIDED - THEY HAD ACCESS ON RIGHT SIDE OF THE PATIENT AND WERE OVER THE BIFURCATION ATTEMPTING TO STENT THE LEFT LEG. DURING DEPLOYMENT, ROUGHLY TWO THIRDS OF THE STENT DEPLOYED AND ONE THIRD WAS STUCK IN THE DEPLOYMENT SYSTEM. THEY ENDED UP BREAKING OPEN THE HANDLE OF THE PTX AND ATTEMPTING TO DEPLOY THE REST OF STENT. THEY WERE ABLE TO GET THE PROXIMAL ONE THIRD OF THE STENT DEPLOYED BUT IT WAS INSIDE OF THE INTRODUCER SHEATH THAT WAS OVER THE BIFURCATION. THE CASE IS STILL GOING ON. THEY ARE PRESENTLY ATTEMPTING TO EXTRACT THE REST OF THE STENT FROM THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345588 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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