Gunther Tulip G52917Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 10827002529172), received between Mar 17, 2015 and Aug 30, 2023 — classified as 4 deaths, 80 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (38 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 111 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Structural Problem; Structural Problem

  IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2013 VIA THE RIGHT FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS (DVT)/ PULMONARY EMBOLISM (PE). ALLEGATIONS INCLUDE: VENA CAVA PERFORATION. IT IS FURTHER ALLEGED THE PATIENT EXPERIENCED "FEAR THAT THE FILTER MIGHT CAUSE FURTHER DAMAGE AS IT HAS NOT YET BEEN REMOVED. " THE PATIENT REPORTEDLY EXPIRED (B)(6) 2021 AND THERE IS CURRENTLY NO REPORTED ALLEGATION OF WRONGFUL DEATH. PER CT REPORT, "FILTER CONE POSITION: BELOW." "FILTER PENETRATION: YES." "IMPRESSIONS: FILTER STRUT PENETRATION THROUGH THE IVC WALL: POSTERIOR LEFT: 14 MM, CORONAL IMAGE 58. POSTERIOR RIGHT: 9 MM, CORONAL IMAGE 60. ANTERIOR LEFT: 15MM, CORONAL IMAGE 51. ANTERIOR RIGHT: NONE." PER CT REPORT, "AN IVC FILTER IS IN PLACE. THE TIP OF THE FILTER LIES JUST BELOW THE LEVEL OF THE LEFT RENAL VEIN. THE POSTERIOR PRONGS OF THE FILTER APPEAR TO EXTEND BEYOND THE LUMEN OF THE IVC BUT DO NOT ABUT THE SPINE. NO ASSOCIATED HEMORRHAGE OR INFLAMMATORY CHANGE." PER CERTIFICATE OF DEATH, DATED (B)(6) 2021, "CAUSE OF DEATH: DRUG INDUCED CARDIAC ARRHYTHMIA (COCAINE, METHORPHAN, DOXYLAMINE, FENTANYL, ALPRAZOLAM, NORBUPRENORPHINE)".

  Patient problems: Perforation of Vessels

  MAUDE report 17654786 ↗
• InjuryJun 29, 2023Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2013 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO POST DEEP VEIN THROMBOSIS (DVT). THE PATIENT ALLEGES ORGAN PERFORATION, VENA CAVA PERFORATION, AND TILT. (B)(6) 2021, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿IVC FILTER WITH APEX NEAR THE RENAL VEIN CONFLUENCE, SLIGHTLY ANGULATED TO THE RIGHT. DISTAL STRUTS EXTEND BEYOND THE IVC LUMEN, ONE ON THE MEDIAL MARGIN IN CLOSE PROXIMITY TO THE DESCENDING ABDOMINAL AORTA.¿

  Patient problems: Insufficient Information; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 17226625 ↗
• InjuryMay 26, 2023Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  PER COMPUTED TOMOGRAPHY REPORT, "FILTER TYPE: COOK GUNTHER TULIP." "IVC STENOSIS: NO" "FILTER POSITION: NO" "FILTER POSITION: BELOW ABOVE THE RENAL VEINS." "FILTER MIGRATION: NONE." "FILTER FRACTURE/BENDING: YES." "FILTER TILT: NO." "FILTER PENETRATION: YES." "IMPRESSIONS: THE ANTERIOR RIGHT STRUT PENETRATES 9 MM THROUGH THE IVC WALL." "THE ANTERIOR LEFT STRUT PENETRATES 10 MM THROUGH THE IVC WALL." "THE POSTERIOR RIGHT STRUT PENETRATES 7 MM THROUGH THE IVC WALL." "THE POSTERIOR LEFT STRUT PENETRATES 7 MM THROUGH THE IVC WALL."

  Patient problems: Abdominal Pain; Decreased Appetite; Insufficient Information; Perforation of Vessels; Pulmonary Embolism; Sleep Dysfunction; Thrombosis/Thrombus

  MAUDE report 17009972 ↗
• InjuryMay 26, 2023Difficult to Remove; Structural Problem; Device Tipped Over; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Structural Problem; Device Tipped Over; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2021 VIA THE RIGHT FEMORAL VEIN DUE TO CONJUNCTION WITH AN ORTHOPEDIC PROCEDURE. PATIENT IS ALLEGING ORGAN/ VENA CAVA PERFORATION, TILT, MIGRATION, EMBEDDED, AND PERCUTANEOUS REMOVAL. PATIENT ALLEGES "DUE TO THE DEVICE, I HAVE SUFFERED ATRIAL FIBRILLATION CONSTANTLY/NONSTOP FOR NEARLY A YEAR. I WAS PLACED ON HEART MEDICATION TO CONTROL MY HEART RATE. I ALSO SUFFERED MAJOR ANXIETY AND DEPRESSION WHERE I COULD FUNCTION WITH MY DAILY LIFE. I WAS PLACED ON MANY DIFFERENT MEDICATIONS TO TRY TO GET MY DEPRESSION AND ANXIETY UNDER CONTROL." "I CAN NO LONGER WALK FOR LONG PERIODS OF TIME AFTER FILTER IMPLANT OR DURING FILTER. DURING FILTER, CERTAIN MOVEMENT WOULD CAUSE SHARP PAINS ON THE SIDE AREA." ADDITIONALLY, PATIENT ALLEGES AN UNSUCCESSFUL FILTER RETRIEVAL ATTEMPT (B)(6) 2021 DUE TO FILTER EMBEDMENT AND A SUCCESSFUL, MORE COMPLEX FILTER RETRIEVAL (B)(6) 2021. RETRIEVAL REPORT (ATTEMPTED): "THE PATIENT WAS BROUGHT TO THE ENDOVASCULAR SUITE, PLACED IN A SUPINE POSITION AND DRAPED IN ROUTINE STERILE FASHION. ALL ASPECTS OF THE 'TIME-OUT' VERIFICATION WERE SATISFACTORILY COMPLETED PRIOR TO THE BEGINNING OF THE PROCEDURE. PLACED IN TRENDELENB

  Patient problems: Anxiety; Atrial Fibrillation; Depression; Device Embedded In Tissue or Plaque; Insufficient Information; Internal Organ Perforation; Pain; Perforation of Vessels

  MAUDE report 17009610 ↗
• InjuryApr 19, 2023Difficult to Remove; Structural Problem; Difficult to Remove; Structural Problem

  IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2017 FOLLOWED BY AN UNSUCCESSFUL RETRIEVAL ON AN UNKNOWN DATE AND A SUCCESSFUL, PERCUTANEOUS REMOVAL ON (B)(6) 2019. PER THE SUCCESSFUL IVC FILTER REMOVAL: "IVC FILTER CAUSING PAIN AND NO LONGER NEEDED. PATIENT FAILED REMOVAL AT OUTSIDE HOSPITAL. "WITH TRACTION ON THE LOOPED GLIDEWIRE, A 17.2 FRENCH GLIDELIGHT LASER SHEATH WAS ADVANCED OVER THE FILTER AND ENGAGED THE INTIMA AT THE LEVEL OF THE IVC FILTER LEG INFILTRATION". "ONCE LASER SHEATH HAD FULLY COVERED THE FILTER LEGS, 18-GAUGE DRY SEAL SHEATH WAS ADVANCED OVER THE SYSTEM AND LASER SHEATH AND FILTER REMOVED INTACT. THE IVC FILTER WAS INSPECTED ON THE BACK TABLE AND NOTED TO BE INTACT. THERE IS SIGNIFICANT FIBRINOUS TISSUE AROUND THE FILTER, WHICH WAS SENT TO PATHOLOGY FOR ASSESSMENT". "IMPRESSION: 1. SUCCESSFUL INFERIOR VENA CAVA FILTER REMOVAL WITH GLIDELIGHT LASER SHEATH. IVC FILTER SENT FOR PATHOLOGY. 2. COMPLETION CAVOGRAM: NO EVIDENCE OF INFERIOR VENA CAVA EXTRAVASATION, STENOSIS OR THROMBOSIS".

  Patient problems: Pain; Perforation of Vessels

  MAUDE report 16773494 ↗
• InjuryFeb 8, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: UPON DEPLOYMENT OF FILTER, WHEN IT WAS UNSHEATHED IT DID NOT EXPAND IN NORMAL FASHION. THEREFORE, THE FILTER WAS RE-SHEATHED AND REMOVED FROM THE PATIENT. THE PHYSICIAN WAS ABLE TO DEPLOY THE FILTER OUTSIDE THE BODY (NOT INSIDE THE PATIENT). THE PHYSICIAN ELECTED TO OPEN AND USE A FILTER (FROM ANOTHER MANUFACTURER) TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY." PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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 16328952 ↗
• InjuryJan 30, 2023Difficult or Delayed Activation; Activation Failure; Difficult or Delayed Activation; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: UPON DEPLOYMENT OF FILTER, WHEN IT WAS UNSHEATHED IT DID NOT EXPAND IN NORMAL FASHION. THEREFORE, THE FILTER WAS RE-SHEATHED AND REMOVED FROM THE PATIENT. THE PHYSICIAN WAS ABLE TO DEPLOY THE FILTER OUTSIDE THE BODY (NOT INSIDE THE PATIENT). THE PHYSICIAN ELECTED TO OPEN AND USE A FILTER (FROM ANOTHER MANUFACTURER) TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY." PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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 16263037 ↗
• InjuryJan 18, 2023Difficult to Remove; Inadequate Filtration Process; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Inadequate Filtration Process; Unintended Movement; 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) 2010, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Insufficient Information; Pulmonary Embolism

  MAUDE report 16194246 ↗
• InjuryDec 19, 2022Activation Failure; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2022 A TULIP IVC FILTER WAS PLACED FROM FEM VEIN PER IFU. AFTER UNSHEATHING AND RELEASING THE FILTER THE CUSTOMER REPORTED THAT THE LEGS OF THE FILTER DID NOT FULLY EXPAND AND IT WAS AS IF THE LEGS WERE TANGLED OR INTERTWINED WITH EACH OTHER. HE HAD TO SERIAL DILATE THE FILTER WITH BALLOONS TO OPEN THE FILTER BACK UP. THE FILTER REMAINED IN THE PATIENT AND IS GOING TO BE RETRIEVED TOMORROW AND A NEW ONE PLACED. PATIENT OUTCOME: THE FILTER REMAINED IN THE PATIENT¿S BODY TILTED UNTIL REMOVED ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16002194 ↗
• InjuryDec 16, 2022Activation Failure; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2022 A TULIP IVC FILTER WAS PLACED FROM FEM VEIN PER IFU. AFTER UNSHEATHING AND RELEASING THE FILTER THE CUSTOMER REPORTED THAT THE LEGS OF THE FILTER DID NOT FULLY EXPAND AND IT WAS AS IF THE LEGS WERE TANGLED OR INTERTWINED WITH EACH OTHER. HE HAD TO SERIAL DILATE THE FILTER WITH BALLOONS TO OPEN THE FILTER BACK UP. THE FILTER REMAINED IN THE PATIENT AND IS GOING TO BE RETRIEVED TOMORROW AND A NEW ONE PLACED. PATIENT OUTCOME: THE FILTER REMAINED IN THE PATIENT¿S BODY TILTED UNTIL REMOVED ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15994942 ↗
• InjuryDec 2, 2022Difficult to Insert; Difficult or Delayed Activation; Difficult to Insert; Difficult or Delayed Activation

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE CUSTOMER STATED THAT THEY ACCESSED THROUGH THE GROIN AND UPON DEPLOYMENT THEY HIT THE SAFETY BLUE BUTTON, FILTER WOULDN'T RELEASE, BUT WHEN IT DID IT RELEASED IN THE SHEATH. IN DELIVERY THEY HAD TO ADVANCE THE CANNULA TO PUSH FILTER OUT OF SHEATH. FILTER WAS PLACED LOWER THAN EXPECTED, BUT NO HARM TO PATIENT. EXPLANT DATE IS TBD (TO BE DETERMINED). REP WILL BE SENDING IN A VIDEO FOR THIS COMPLAINT. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15902787 ↗
• InjuryNov 28, 2022Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available; Structural Problem; Device Tipped Over; 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) 2013, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Dyspnea; Insufficient Information; Perforation of Vessels

  MAUDE report 15870117 ↗
• InjuryNov 21, 2022Malposition of Device; Malposition of Device

  ACCORDING TO THE INITIAL REPORTER: THE CUSTOMER STATED THAT THEY ACCESSED THROUGH THE GROIN AND UPON DEPLOYMENT THEY HIT THE SAFETY BLUE BUTTON, FILTER WOULDN'T RELEASE, BUT WHEN IT DID IT RELEASED IN THE SHEATH. IN DELIVERY THEY HAD TO ADVANCE THE CANNULA TO PUSH FILTER OUT OF SHEATH. FILTER WAS PLACED LOWER THAN EXPECTED, BUT NO HARM TO PATIENT. EXPLANT DATE IS TBD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834244 ↗
• InjurySep 26, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT OF UNSPECIFIED GENDER AND AGE UNDERWENT A VENA STENTING IN THE ILIAC PROCEDURE AND THE PHYSICIAN CONCLUDED THE PATIENT WOULD ALSO NEED A VENA CAVA FILTER. THEREFORE A GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET, G52917, WAS USED. UPON DEPLOYING APPROXIMATELY ONE THIRD OF THE FILTER HOOK STUCK INSIDE BRANCH OF THE INFERIOR VENA CAVA BUT COULD NOT TELL WHICH ONE. AT THIS POINT THE DISTRICT MANAGER WAS CALLED THE PROCEDURE TO ASSIST WITH THE REMOVAL. THE FILTER WAS NOT TOTALLY DETACHED. THE PHYSICIAN TRIED TO PULL BACK ON THE FILTER, HOWEVER COULD NOT AS THERE WAS A PREVIOUSLY PLACED STENT THERE. THEN TRIED RE-SHEATHING WITH THE FILTER SHEATH, HOWEVER THE SIDE ARMS BECAME TANGLED INSIDE AND COULD NOT PULL THE SIDE ARMS IN. THE DEVICE WAS DEPLOYED WHERE IT WAS WITH THE FEET DEPLOYED INSIDE THE STENT IN THE LEFT ILIAC. THE PHYSICIAN BALLOONED AND OPENED THE FEET AND SOME FEET WERE ALSO IN THE RIGHT ILIAC. THE FILTER WAS ALSO DEPLOYED WHERE IT WAS AS THE PATIENT WAS HAVING DISCOMFORT WHILE ATTEMPTING TO PULL THE FILTER OUT. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15484446 ↗
• InjurySep 20, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A PATIENT OF UNSPECIFIED GENDER AND AGE UNDERWENT A VENA STENTING IN THE ILIAC PROCEDURE AND THE PHYSICIAN CONCLUDED THE PATIENT WOULD ALSO NEED A VENA CAVA FILTER. THEREFORE A GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET, G52917, WAS USED. UPON DEPLOYING APPROXIMATELY ONE THIRD OF THE FILTER HOOK STUCK INSIDE BRANCH OF THE INFERIOR VENA CAVA BUT COULD NOT TELL WHICH ONE. AT THIS POINT THE DISTRICT MANAGER WAS CALLED THE PROCEDURE TO ASSIST WITH THE REMOVAL. THE FILTER WAS NOT TOTALLY DETACHED. THE PHYSICIAN TRIED TO PULL BACK ON THE FILTER, HOWEVER COULD NOT AS THERE WAS A PREVIOUSLY PLACED STENT THERE. THEN TRIED RE-SHEATHING WITH THE FILTER SHEATH, HOWEVER THE SIDE ARMS BECAME TANGLED INSIDE AND COULD NOT PULL THE SIDE ARMS IN. THE DEVICE WAS DEPLOYED WHERE IT WAS WITH THE FEET DEPLOYED INSIDE THE STENT IN THE LEFT ILIAC. THE PHYSICIAN BALLOONED AND OPENED THE FEET AND SOME FEET WERE ALSO IN THE RIGHT ILIAC. THE FILTER WAS ALSO DEPLOYED WHERE IT WAS AS THE PATIENT WAS HAVING DISCOMFORT WHILE ATTEMPTING TO PULL THE FILTER OUT. 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 15453537 ↗
• InjurySep 2, 2022Appropriate 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) 2014, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15348415 ↗
• InjuryAug 30, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE WHITE PLASTIC HUB THAT HOUSES THE SAFETY AND RELEASES MECHANISM WAS NOT ALIGNED PROPERLY. THEY STATED IT WAS A VERY SMALL MISALIGNMENT. THEY REALIGNED IT AND CONTINUED WITH THE PROCEDURE. WHEN TRYING TO DEPLOY, THE FILTER WOULD NOT DISENGAGE FROM THE RELEASE MECHANISM. THEY THEN TRIED TO RE-SHEATH IT AND COULDN¿T COVER THE HOOK ON THE FILTER. ON THE WAY OUT THE FILTER GOT SNAGGED AND RELEASED IN THE FEMORAL VEIN. THE FILTER WAS OFF OF THE DEVICE BUT THE FEET WERE NOT DEPLOYED. THE FILTER THEN HAD TO BE SNARED FROM A JUGULAR VEIN APPROACH. PATIENT OUTCOME: NO HARM CAME TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322848 ↗
• InjuryAug 17, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE WHITE PLASTIC HUB THAT HOUSES THE SAFETY AND RELEASES MECHANISM WAS NOT ALIGNED PROPERLY. THEY STATED IT WAS A VERY SMALL MISALIGNMENT. THEY REALIGNED IT AND CONTINUED WITH THE PROCEDURE. WHEN TRYING TO DEPLOY, THE FILTER WOULD NOT DISENGAGE FROM THE RELEASE MECHANISM. THEY THEN TRIED TO RE-SHEATH IT AND COULDN¿T COVER THE HOOK ON THE FILTER. ON THE WAY OUT THE FILTER GOT SNAGGED AND RELEASED IN THE FEMORAL VEIN. THE FILTER WAS OFF OF THE DEVICE BUT THE FEET WERE NOT DEPLOYED. THE FILTER THEN HAD TO BE SNARED FROM A JUGULAR VEIN APPROACH. PATIENT OUTCOME: NO HARM CAME TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15238426 ↗
• InjuryJul 19, 2022Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available; Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Device Tipped Over; 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, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Anxiety; Depression; Insufficient Information; Internal Organ Perforation; Perforation of Vessels; Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 15052833 ↗
• InjuryJul 18, 2022Activation Failure; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: INFORMATION RECEIVED 27JUN2022 FROM REVIEW OF MEDICAL RECORDS FOR RELATED COMPLAINT (B)(4): THE PATIENT HAD APPARENTLY PATENT RIGHT ILIAC VEIN AND INFERIOR VENA CAVA. INITIAL DEPLOYMENT OF THE FILTER SHOWED FAILURE TO FULLY DEPLOY. SUSPECTED THE FILTER MAY HAVE BEEN TRAPPED IN A WEB WITHIN THE VEIN WALL. THE FILTER WAS, THEREFORE, SNARED WITH A GOOSENECK SNARE AN REPOSITIONED IN THE INFERIOR VENA CAVA AT THE POINT WHERE IT NOW FULLY DEPLOYED. COMPLETION VENOGRAM DID NOT SHOW ANY COMPLICATION. PATIENT OUTCOME: COMPLETION VENOGRAM DID NOT SHOW ANY COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15040690 ↗
• InjuryJun 28, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER INFRARENALLY ON (B)(6) 2014 TO AVOID THE RISK OF PULMONARY EMBOLISM.. APPROXIMATELY 4 YEARS AND 11 MONTHS LATER, THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY (CT) SCAN OF THE PATIENT'S ABDOMEN. THE CT SCAN REVEALED THAT THE STRUTS OF THE COOK TULIP FILTER HAD PERFORATED OUTSIDE OF THE WALL OF THE IVC. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 14847437 ↗
• InjuryJun 28, 2022Obstruction of Flow; Structural Problem; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Structural Problem; 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) 2013, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Insufficient Information; Internal Organ Perforation; Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 14846983 ↗
• InjuryJun 20, 2022Difficult to Remove; Structural Problem; Device Tipped Over; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Structural Problem; Device Tipped Over; Unintended Movement; 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) 2015, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Chest Pain; Device Embedded In Tissue or Plaque; Insufficient Information; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 14743944 ↗
• MalfunctionJun 15, 2022Difficult to Remove; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Obstruction of Flow; 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) 2010, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Abdominal Pain; Depression; Insufficient Information; Pain; Thrombosis/Thrombus

  MAUDE report 14691588 ↗
• InjuryJun 15, 2022Appropriate 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) 2014, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14691564 ↗