Gunther Tulip G52916Recalls & reported problems

Summary

The FDA's MAUDE database contains 189 adverse event reports that list this exact device (DI 10827002529165), received between Jan 28, 2015 and Sep 8, 2025 — classified as 2 deaths, 70 injuries, 115 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (25 reports).

1 FDA recall record name this device's 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, 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.

Recalls naming this device

1. Feb 14, 2022Class IIITerminated

   IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events

   Z-0875-2022 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 189 reports, in the reporter's own words as published by the FDA.

• DeathSep 8, 2025Inadequate Filtration Process; Inadequate Filtration Process

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2025, A FILTER WAS PLACED IN THE INFERIOR VENA CAVA (IVC) VIA THE RIGHT JUGULAR VEIN. AFTER FILTER PLACEMENT, THE PATIENT RETURNED TO THE ROOM. SUBSEQUENTLY (TIMING UNKNOWN), CARDIAC ARREST OCCURRED AND THE PATIENT DIED. THE PHYSICIAN DOES NOT KNOW THE CAUSE BECAUSE SHE HAS NOT DONE AN AUTOPSY, BUT SHE THINKS THE BLOOD CLOT MAY HAVE SLIPPED THROUGH THE FILTER AND CAUSED PULMONARY EMBOLISM. ON (B)(6) 2025: AFTER OVARIAN TUMOR REMOVAL, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). ON (B)(6) 2025: D-DIMER LEVEL WAS HIGH (12.2), AND AN ULTRASOUND CONFIRMED DEEP VENOUS THROMBOSIS (DVT), BUT PULMONARY EMBOLISM (PE) WAS NOT CONFIRMED. INTRAVENOUS (IV) HEPARIN 3.5CC WAS STARTED. ON (B)(6) 2025: AN IVC FILTER WAS PLACED TO PREVENT DVT DISPERSION. HEPARIN 3CC/6H WAS ADMINISTERED 4 TIMES. ON (B)(6) 2025: THE PATIENT BEGAN TO GET OUT OF BED, AND WAS ABLE TO STAND WITHOUT ANY PROBLEMS, SO WAS TRANSFERRED FROM THE ICU TO THE GENERAL WARD. WHEN THE PATIENT BEGAN STEPPING FOR REHABILITATION PURPOSES, SHE LOST CONSCIOUSNESS AT 15:07. HER PULSE WEAKENED AND SHE WENT INTO CARDIAC ARREST, SO SHE WAS MOVED TO THE CATHETERIZATION

  Patient problems: Embolism/Embolus

  MAUDE report 22990676 ↗
• InjuryMay 28, 2025Activation Failure; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: GUNTHER TULIP FILTER REPLACEMENT. THE GUNTHER THAT HAD BEEN PLACED WAS SUCCESSFULLY RETRIEVED, AND THE LEGS OF THE NEWLY PLACED IGTCFS-65-1-JUG-TULIP BECAME TANGLED AND DID NOT DEPLOY. THE GUNTHER THAT HAD BEEN PLACED WAS REMOVED USING THE DEVICE (GTRS) THAT WAS USED TO RETRIEVE IT, AND A DIFFERENT DEVICE WAS PLACED. PATIENT OUTCOME: NO HEALTH HAZARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094482 ↗
• MalfunctionJan 16, 2025Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE INFERIOR VENA CAVA FILTER DID NOT COME OFF WHEN IT WAS DEPLOYED. IT WAS PLACED BACK INTO THE SHEATH AND REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER IGTCFS-65-1-JUG-TULIP FROM THE HOSPITAL INVENTORY AND IT WAS SUCCESSFULLY PLACED. THE FILTER DID NOT COME OFF THE INTRODUCER HOOK EVEN WHEN THE BLUE RELEASE BUTTON WAS PRESSED. THE FILTER WAS DEPLOYED IN THE JUGULAR VEIN, JUST BELOW THE RENAL VEIN. DUE TO THE FILTER RELEASE FAILURE, IT WAS PLACED BACK INTO THE SHEATH AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21165822 ↗
• InjuryDec 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2017. IT IS ALLEGED THAT THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20833863 ↗
• MalfunctionNov 14, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHEN THE INFERIOR VENA CAVA WAS ACCESSED FROM THE JUGULAR VEIN FOR IVC FILTER PLACEMENT, THE FILTER FAILED TO EXPAND, SO THE FILTER WAS RETURNED INTO THE SHEATH AND ABANDONED FILTER PLACEMENT. AS THERE WAS NO REPLACEMENT DEVICE AVAILABLE ON THE DAY, THE PROCEDURE WAS RESCHEDULED. PATIENT OUTCOME: NO ADVERSE EFFECT ON THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20680641 ↗
• MalfunctionSep 30, 2024Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE INFERIOR VENA CAVA WAS APPROACHED FROM THE RIGHT JUGULAR VEIN. AFTER DETERMINING THE PLACEMENT POSITION JUST BELOW THE RENAL VEIN, THE PHYSICIAN DEPLOYED THE FILTER AND ATTEMPTED TO RELEASE IT, BUT THE FILTER WAS NOT RELEASED, SO HE COVERED THE FILTER WITH THE SHEATH AGAIN AND REMOVED IT. THE PROCEDURE WAS COMPLETED WITH THE PLACEMENT OF A TEMPORARY FILTER FROM ANOTHER MANUFACTURER. PATIENT OUTCOME: NO ADVERSE EFFECT ON THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20331974 ↗
• MalfunctionSep 30, 2024Activation Failure; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THIS WAS A CASE OF EMERGENCY SURGERY. THERE WAS A BLOOD CLOT IN BOTH LEGS AND THE RIGHT INTERNAL JUGULAR VEIN. APPROACHED FROM THE RIGHT INTERNAL JUGULAR VEIN. THE PHYSICIAN PRESSED THE RED SAFETY LOCK AND THEN THE BLUE RELEASE BUTTON BUT THE FILTER WAS NOT RELEASED. HE PRESSED THE BLUE RELEASE BUTTON SEVERAL TIMES BUT THE FILTER WAS NOT RELEASED SO THE DEVICE WAS REMOVED FROM THE PATIENT BODY. THE PROCEDURE WAS COMPLETED BY USING COMPETITOR'S PRODUCT (BD/DENALI IVC FILTER) INSTEAD OF IGTCFS-65-1-JUG-TULIP. PATIENT OUTCOME: NO ADVERSE EFFECT ON THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20331847 ↗
• InjuryAug 7, 2024Difficult to Remove; Structural Problem; Device Tipped Over; Difficult to Remove; Structural Problem; Device Tipped Over

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation of Vessels

  MAUDE report 19928009 ↗
• InjuryFeb 21, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PHYSICIAN WENT TO DEPLOY THE FILTER, BUT THE FILTER WOULD NOT DEPLOY. THE PHYSICIAN WAS ABLE TO GET FILTER TO EVENTUALLY DEPLOY (THE FILTER DEPLOYED CROOKED), BUT IT TOOK A LOT OF WORK TO DO SO, IN THAT PURSUIT, THE USER HAD TO OPEN AND USE A SNARE TO REPOSITION / ALIGN THE FILTER ACCORDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18751718 ↗
• InjuryFeb 6, 2024Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18648692 ↗
• InjuryJan 11, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE DOCTOR WAS TRYING TO DEPLOY A JUG CELECT FILTER THAT WOULD NOT DETACH (B)(4). HE HAD TO OPEN A SECOND FILTER THAT WAS A JUG TULIP AND HAD THE SAME ISSUE (B)(4). HE TRIED APPLYING FORWARD PRESSURE TO UNHOOK THE FILTER BUT THAT PUSHED THE FILTER INTO THE RENAL VEIN. HE HAD TO OPEN A RETRIEVAL SYSTEM AND RETRIEVE THIS FILTER. HE HAD TO OPEN A THIRD FILTER FOR PLACEMENT.

  Patient problems: Failure of Implant

  MAUDE report 18493689 ↗
• InjuryJan 3, 2024Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE DOCTOR WAS TRYING TO DEPLOY A JUG CELECT FILTER THAT WOULD NOT DETACH (B)(4). HE HAD TO OPEN A SECOND FILTER THAT WAS A JUG TULIP AND HAD THE SAME ISSUE (B)(4). HE TRIED APPLYING FORWARD PRESSURE TO UNHOOK THE FILTER BUT THAT PUSHED THE FILTER INTO THE RENAL VEIN. HE HAD TO OPEN A RETRIEVAL SYSTEM AND RETRIEVE THIS FILTER. HE HAD TO OPEN A THIRD FILTER FOR PLACEMENT.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434507 ↗
• MalfunctionDec 12, 2023Premature Activation; Premature Activation

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: APPROACHED FROM THE RIGHT JUGULAR VEIN TO THE INFERIOR VENA CAVA. THE DEVICE WAS ADVANCED TO THE IMPLANTATION POSITION AND THE FILTER WAS EXPANDED, BUT WHEN IT WAS RE-STOWED INTO THE DELIVERY SHEATH TO ADJUST THE IMPLANTATION POSITION, THE DELIVERY CATHETER (FILTER CATHETER) WAS FOUND TO BE DETACHED FROM THE FILTER. THEREFORE, THE DELIVERY CATHETER (FILTER CATHETER) WAS COMPLETELY REMOVED, A 0.014 WIRE GUIDE WAS LOOPED AND BROUGHT INTO THE SHEATH, HOOKED ONTO THE HOOK OF THE FILTER, AND THE DELIVERY SHEATH WAS REMOVED (BECAUSE IT COULD FALL OUT INTO THE BODY IF REMOVED AS IS). THE PROCEDURE WAS COMPLETED BY USING ANOTHER IGTCFS-65-1-JUG-TULIP WITH A DIFFERENT LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18309509 ↗
• MalfunctionDec 4, 2023Premature Activation; Improper or Incorrect Procedure or Method; Premature Activation; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: (B)(6) 2023: AFTER THE USER DEPLOYED THE FILTER, HE WAS ATTEMPTING TO RE-SHEATH THE FILTER, AND THE FILTER HOOK WAS RELEASED FROM THE FILTER CATHETER WITHOUT INTENTION. THE FILTER WAS INSIDE THE CATHETER SHEATH AT THE UNINTENDED RELEASE, SO HE REMOVED THE WHOLE SYSTEM WITH THE FILTER INSIDE FROM THE PATIENT BODY AND ENDED THE PROCEDURE. (B)(6) 2023: HE CONDUCTED ANOTHER FILTER PLACEMENT USING ANOTHER IGTCFS-65-1-JUG-TULIP AND PLACED A FILTER SUCCESSFULLY. PATIENT OUTCOME: THE PATIENT HAD TO BE UNDER SECOND FILTER PLACEMENT NEXT DAY. ALTHOUGH THE PATIENT IS DOING FINE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18259239 ↗
• InjuryOct 19, 2023Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: AFTER CATCHING THE HOOK OF THE FILTER IGTCFS-65-1-JUG-TULIP WITH A SNARE GTRS-200-RB, THERE WAS RESISTANCE DURING INSERTION INTO THE RETRIEVAL SHEATH AND THE USER ROTATED THE FILTER. IN DOING SO, IT PROBABLY ENTRAPPED PART OF THE VEIN'S INTIMA, CAUSING THE LEG TO CLOSE. THE FILTER WAS NOT ABLE TO BE PULLED INTO THE SHEATH DUE TO THE ENTRAPMENT OF THE VEIN AND COULD NOT BE RETRIEVED. THE FEMORAL SIDE WAS PUNCTURED AND ANOTHER SNARE WAS USED, AND RETRIEVAL WAS SOMEHOW COMPLETED. THE USER BELIEVES THAT THE VEIN ENTRAPMENT CAUSED BY THE ROTATION OF THE FILTER WAS THE CAUSE OF THE DIFFICULTY IN REMOVAL. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17964099 ↗
• InjuryMay 16, 2023Improper or Incorrect Procedure or Method; Device Tipped Over; Improper or Incorrect Procedure or Method; Device Tipped Over

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16937684 ↗
• InjuryMay 2, 2023Fracture; Fracture

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PHYSICIAN WENT TO DEPLOY THE TULIP FROM THE JUGULAR APPROACH AS HE UN-SHEATHED THE FILTER HE NOTICED THE LEGS DID NOT OPEN UP TO THE DIAMETER OF THE IVC. HE THEN DECIDED TO RECAPTURE IT. HE WAS ABLE TO GET THE FILTER HALFWAY INTO THE DELIVERY SHEATH WITH THE RELEASE MECHANISM BROKE. THE FILTER WAS STILL HALFWAY OUT THE DELIVERY SHEATH. THE PHYSICIAN DID NOT WANT TO REMOVE THAT WAY, SO HE DECIDED TO PUSH THE FILTER OUT OF THE SHEATH WITH A WIRE. THE LEGS STILL DID NOT OPEN UP. HE WAS ABLE TO RETRIEVE THE FILTER USING THE CLOVERSNARE. ONCE THE FILTER WAS RETRIEVED IT WAS PLACED INTO A SPECIMEN CUP, THE LEGS THEN OPENED UP. HE THEN PLACED AN FILTER FORM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16853584 ↗
• InjuryApr 27, 2023Activation Failure; Activation Failure

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822066 ↗
• InjuryApr 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2012 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO A HISTORY OF PULMONARY EMBOLISM (PE), FOLLOWED BY SUCCESSFUL PERCUTANEOUS FILTER RETRIEVAL ON (B)(6) 2016. PER THE SUCCESSFUL IVC FILTER REMOVAL: "A SPOT IMAGE OF THE CHEST WAS OBTAINED, SHOWING ABSENCE OF ANY IDENTIFIABLE FILTER STRUTS IN THE IMAGED PORTION OF THE CHEST. 0.035 GUIDEWIRE WAS THEN PLACED THROUGH THE RIGHT ATRIUM TO THE INFERIOR VENA CAVA BELOW THE LEVEL OF THE FILTER, WHICH APPEARS IN VERY SIMILAR POSITION TO ITS ORIGINAL PLACEMENT". "INFERIOR VENACAVOGRAM WAS PERFORMED, SHOWING NO SIGNIFICANT THROMBUS WITHIN THE FILTER, AND A WIDELY PATENT IVC". "9 FRENCH INNER SHEATH WAS THEN ADVANCED OVER THE FILTER TO COLLAPSE IT, AND THE FILTER WAS THEN PULLED INTO THE SHEATH AND ITS ENTIRETY". "IMPRESSION: SUCCESSFUL REMOVAL OF INFRARENAL INFERIOR VENA CAVA FILTER. INSPECTION OF THE FILTER FOLLOWING REMOVAL SHOWS THE FILTER TO BE INTACT, WITH NO APPARENT MISSING STRUTS OR FRAGMENTS".

  Patient problems: Insufficient Information

  MAUDE report 16799458 ↗
• InjuryApr 17, 2023Unintended Movement; Unintended Movement

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: AFTER INSERTING THE FILTER CATHETER INTO THE SHEATH, THE USER ATTEMPTED TO DEPLOY THE FILTER BUT THERE WAS A POSSIBILITY THAT THE FILTER CATHETER MIGHT HAVE ADVANCED IN THE BLOOD VESSEL OTHER THAN IVC SO HE STOPPED DEPLOYING. HE ATTEMPTED TO PULL BACK THE FILTER CATHETER IN TO THE SHEATH FORCEDLY, FILTER WAS STAYED OFF AT THE TIP OF THE SHEATH. WHEN HE ATTEMPTED TO REMOVE THE SHEATH OUT OF THE PATIENT'S BODY, THE FILTER DROPPED OFF AND FLOWED IN THE RIGHT ATRIUM. HE MANAGED TO RETRIEVE THE FILTER FROM THE RIGHT ATRIUM USING A SNARE AND A GUIDING SHEATH. PATIENT OUTCOME: NO HEALTH HAZARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16749702 ↗
• InjuryMar 23, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE RED SAFETY BUTTON COULDN¿T BE DEPRESSED ALL THE WAY WHICH THEN LED TO THE BLUE RELEASE BUTTON NOT BEING ABLE TO BE DEPRESSED. THE PHYSICIAN PRESSED THE RED SAFETY HARDER WITH A HEMOSTAT AND THEN WAS ABLE TO RELEASE THE FILTER, WHICH WAS TILTED AND NEEDED TO BE RETRIEVED. THE PHYSICIAN GRABBED ANOTHER SET OFF THE SHELF AND HAD THE SAME ISSUE WITH THE RED SAFETY BUTTON, BUT THE FILTER EVENTUALLY WAS RELEASED CLEANLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598017 ↗
• InjuryMar 9, 2023Improper or Incorrect Procedure or Method; Device Tipped Over; Improper or Incorrect Procedure or Method; Device Tipped Over

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16510889 ↗
• InjuryJan 27, 2023Premature Activation; Premature Activation

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PLACING THE FILTER THROUGH THE RIGHT INTERNAL JUGULAR IJ ACCESS. THE PHYSICIAN WAS MANIPULATE THE DEVICE AND WAS UNABLE TO GET THE FILTER TO DEPLOY. IN THE PROCESS OF TRYING TO RE-SHEATH THE FILTER, THE PHYSICIAN INADVERTENTLY DEPLOYED THE FILTER IN SUPRA RENAL. ANOTHER PHYSICIAN RETRIEVED THE FILTER AS IT WAS PLACED IN THE INCORRECT LOCATION. THE PHYSICIAN PLACED A SECONDARY FILTER THAT DEPLOYED SUCCESSFULLY TO COMPLETE THE INTENDED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16253536 ↗
• InjuryJan 23, 2023Premature Activation; Difficult or Delayed Activation; Premature Activation; Difficult or Delayed Activation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16222742 ↗
• InjuryDec 22, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PATIENT WAS HAVING AN OPEN SURGERY FOR ANOTHER TREATMENT. THE SURGEON NOTED THAT THE FILTER WAS PENETRATED FROM THE IVC DURING THE SURGERY. DEGREE OF THE PENETRATION WAS UNKNOWN. (B)(6) 2022: THE FILTER WAS PLACED FOR DVT (DEEP VEIN THROMBOSIS) BY THE RIGHT JUG APPROACH. NO TILTING WAS CONFIRMED. IT WAS PLACED STRAIGHT UP AGAINST THE IVC. (B)(6) 2022: TILT OF THE FILTER WAS CONFIRMED BY FOLLOW-UP CT IMAGES. (B)(6) 2022: THE PATIENT HAD AN OPEN SURGERY TO REMOVE OVARIAN CANCER AT THE DEPARTMENT OF GYNECOLOGY BY A GYNECOLOGIST. WHEN THE PHYSICIAN WHO PLACED THE FILTER TO THE PATIENT CHECKED IT VISUALLY, HE CONFIRMED APPROX. 5MM-PENETRATION OF THE FILTER. THEN THE GYNECOLOGIST CONTINUED A PROTECTIVE SURGICAL PROCEDURE BY COVERING THE ADJACENT STRUCTURES WITH FAT IN ORDER TO AVOID THEM FROM DAMAGING.

  Patient problems: Great Vessel Perforation

  MAUDE report 16031980 ↗