Gunther Tulip G33016Recalls & reported problems

Summary

The FDA's MAUDE database contains 348 adverse event reports that list this exact device (DI 10827002330167), received between Dec 15, 2015 and Aug 23, 2024 — classified as 3 deaths, 262 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (128 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 348 reports, in the reporter's own words as published by the FDA.

• DeathAug 23, 2024Difficult to Remove; Obstruction of Flow; Structural Problem; Difficult to Remove; Obstruction of Flow; Structural Problem

  THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2010 TO PREVENT BLOOD CLOTS. THE FOLLOWING IS ALLEGED: DEATH, STROKE, VENA CAVA AND ORGAN PERFORATION, BLOOD CLOTS, AND DEVICE IS UNABLE TO BE RETRIEVED. IT IS NOTED AND FURTHER ALLEGED, THE PATIENT EXPERIENCED POOR GENERAL HEALTH DUE TO THE FILTER. APPROXIMATELY 11 YEARS AND 3 MONTHS AFTER RECEIVING THE FILTER IMPLANT, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN AND THE IMAGING FROM THIS SCAN SHOWED THAT THE LEGS OF THE PATIENT'S FILTER HAD PENETRATED THE IVC. THE SCAN ALSO SHOWED THAT THE FILTER LEGS HAD "GONE INTO" THE PATIENT'S PANCREAS, DUODENUM, AND WERE ALSO NEAR THE RENAL VEIN. THE PATIENT EXPIRED ABOUT A MONTH AFTER THE AFOREMENTIONED CT SCAN. THE DEATH CERTIFICATE LISTS INTRACEREBRAL HEMORRHAGE, CHRONIC ANTICOAGULATION, AND DEEP VENOUS THROMBOSIS (DVT) AS THE CAUSES OF DEATH. WRONGFUL DEATH IS ALLEGED BY THE PATIENT'S ESTATE. PER THE DEATH CERTIFICATE: CAUSE OF DEATH: INTRACEREBRAL HEMORRHAGE; CHRONIC ANTICOAGULATION; DEEP VENOUS THROMBOSIS. OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO DEATH: TRAUMATIC BRAIN INJURY; OSTEOMYELITIS.

  Patient problems: Internal Organ Perforation; Perforation of Vessels; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 20051069 ↗
• InjuryMar 18, 2024Obstruction of Flow; Structural Problem; Unintended Movement; Obstruction of Flow; Structural Problem; Unintended Movement

  PATIENT ALLEGEDLY RECEIVED THE TULIP FILTER ON (B)(6) 2014 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO BARIATRIC SURGERY. PATIENT IS ALLEGING DEVICE MIGRATION, VENA CAVA AND ORGAN PERFORATION. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING "GROIN PAIN, BACK PAIN, ABDOMINAL & CHEST PAIN. I ALSO HAVE DIFFICULTY WALKING (LIMP) AND CANNOT STAND. I HAVE SHARP THROBBING PAIN IN MY CHEST AND I AM ON LIFE-LONG ANTICOAGULATION WHICH PREVENTS ME FROM MAINTAINING A HEALTHY LIFESTYLE", "CANNOT RIDE A BICYCLE, CURRENTLY SWIM". ADDITIONALLY, PATIENT ALLEGES TWO DEEP VEIN THROMBOSIS AFTER FILTER IMPLANT AND, ANXIETY. PER A REPORT FROM COMPUTED TOMOGRAPHY (CT) 2: "COOK GUNTHER TULIP FILTER PLACED (B)(6) 2014. CAVAL PERFORATION: YES. 4:30 O'CLOCK 3.9 MM GRADE 4 EXTENDING INTO THE L4 VERTEBRAL BODY. TILT: NO. MIGRATION: NO. PERTINENT NEGATIVES: NONE. ADDITIONAL FINDINGS: NONE". PER A REPORT FROM CT: "ACUTE DEEP VENOUS THROMBOSIS BILATERAL COMMON FEMORAL VEINS SHOWN BY ULTRASOUND NOVEMBER 23". "IMPRESSION: 1. NONOCCLUSIVE THROMBUS IN RIGHT COMMON FEMORAL VEIN. OCCLUSIVE THROMBUS LEFT COMMON FEMORAL AND EXTERNAL AND COMMON ILIAC VEIN NOT EXCLUDED, IVC THROMBUS NOT EXCLUDED, BUT TECHNIQUE NOT OPTIMIZED FO

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Anxiety; Chest Pain; Internal Organ Perforation; Pain; Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 18924516 ↗
• InjuryMar 18, 2024Structural Problem; Device Tipped Over; Unintended Movement; Structural Problem; Device Tipped Over; Unintended Movement

  UPDATE 21FEB2024: PATIENT ALLEGEDLY RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2011 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO ACUTE PULMONARY EMBOLISM (PE). PER A REPORT FROM COMPUTED TOMOGRAPHY (CT): "CAVAL PERFORATION: YES. GRADE 4 PERFORATION OF 12 O'CLOCK STRUT INTO DUODENUM. GRADE 3 PERFORATION OF 6 O'CLOCK STRUT TO ABUT L3 VERTEBRAL BODY. MULTIPLE GRADE 1 PERFORATIONS. TILT: YES. NO SUBSTANTIAL CORONAL TILT. 10.79 DEGREES OF SAGITTAL TILT. APEX OF FILTER TOUCHES ANTERIOR WALL OF IVC. MIGRATION: YES. APEX OF FILTER 0.9 CM ABOVE THE LEFT RENAL VEIN CONFLUENCE. PERTINENT NEGATIVES: NO FRACTURE OR MISSING STRUTS SEEN. NO IVC STENOSIS. ADDITIONAL FINDINGS: NO".

  Patient problems: Internal Organ Perforation; Perforation of Vessels

  MAUDE report 18922937 ↗
• InjuryJan 25, 2024Difficult to Remove; Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Difficult to Remove; Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component

  PATIENT ALLEGEDLY RECEIVED A GUNTHER-TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2011 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO A HISTORY OF PULMONARY EMBOLISM (PE) AND INABILITY TO TAKE ANTICOAGULANTS. PATIENT IS ALLEGING DEVICE TILT, VENA CAVA AND ORGAN PERFORATION (WITH TINES ABUTTING THE ABDOMINAL AORTA AND THE PSOAS MUSCLE), DEVICE FRACTURE, UNABLE TO BE RETRIEVED, AND EMBEDMENT. IT IS ALLEGED THE PATIENT UNDERWENT TWO UNSUCCESSFUL PERCUTANEOUS FILTER RETRIEVAL ATTEMPTS ((B)(6) 2022) AND A FINAL SUCCESSFUL PERCUTANEOUS RETRIEVAL ((B)(6) 2022) WITH TWO FRACTURED TINES REMAINING IN PATIENT. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING PAIN AND DISTRESS RESTRICTING THE ABILITY TO ENGAGE IN ACTIVITIES OF DAILY LIVING AS WELL AS USE OF APPROXIMATELY "20% OF MY HANDS MY BACK", PATIENT CANNOT GET UP OR DOWN; "THEY BROKE THE HOOK OF FILTER OFF IN MY KIDNEY AND CAN NEVER GET IT OUT". "I CANT LIFT, HOLD ANYTHING W/HANDS WEAK". PER A CT ABDOMEN/PELVIS: "AN IVC FILTER IS NOTED WITHIN THE INFERIOR VENA CAVA. THE IVC FILTER EXTENDS STRUTS EXTENT BEYOND THE IVC WALL. ONE PRONG/STRUT ABUTS THE AORTA. ANOTHER ABUTS THE PSOAS MUSCLE. THERE IS EXTENSION OF THE STRUTS BEYOND THE IVC WALL O

  Patient problems: Device Embedded In Tissue or Plaque; Distress; Internal Organ Perforation; Muscle Weakness/Atrophy; Pain; Perforation of Vessels; Stenosis

  MAUDE report 18580588 ↗
• InjuryOct 10, 2023Structural Problem; Structural Problem

  PATIENT ALLEGEDLY RECEIVED A COOK GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2015 VIA RIGHT COMMON FEMORAL VEIN DUE TO TRAUMA. PATIENT IS ALLEGING ORGAN AND VENA CAVA PERFORATION. PER A REPORT OF COMPUTED TOMOGRAPHY (CT) 1 DATED 30AUG2021, "IVC STENOSIS: NO. FILTER POSITION: BELOW THE RENAL VEINS. FILTER MIGRATION: NONE. FILTER FRACTURE/BENDING: NO. FILTER TILT: NO. FILTER PENETRATION: YES. OTHER FINDINGS: YES. IMPRESSIONS: THE FILTER IS NOT TILTED BUT THE CONE OF THE FILTER IS AGAINST THE ANTERIOR WALL OF THE IVC. AXIAL IMAGE 34. THE ANTERIOR STRUT PENETRATES 8 MM THROUGH THE IVC WALL. IT PENETRATES INTO THE DUODENUM. SAGITTAL IMAGE 71. THE LEFT STRUT PENETRATES 5 MM THROUGH THE IVC WALL. CORONAL IMAGE 70. THE POSTERIOR STRUT PENETRATES 9 MM THROUGH THE IVC WALL. SAGITTAL IMAGE 72. THE RIGHT STRUT PENETRATES 6MM THROUGH THE IVC WALL. IT PENETRATES INTO THE DUODENUM. CORONAL IMAGE 71."

  Patient problems: Internal Organ Perforation; Perforation of Vessels

  MAUDE report 17905816 ↗
• InjuryAug 22, 2023Obstruction of Flow; Structural Problem; Device Tipped Over; Obstruction of Flow; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT IN (B)(6) 2012 VIA THE UNSPECIFIED FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS (DVT). THE PATIENT ALLEGES VENA CAVA PERFORATION AND TILT. THE PATIENT FURTHER ALLEGES 4 PRONGS PERFORATE THE INFERIOR VENA CAVA, MAXIMUM DISTANCE OF PERFORATION IS 3.63 MM, 4.72-DEGREE TILT SUPERIOR LEFT TO INFERIOR RIGHT, LIMITED ACTIVITY, PAIN, INTERNAL BLEEDING, SWELLING, CLOTTING, SCARRING, AND DEFECTIVE FOREIGN OBJECT IN THE BODY PROVIDING REDUCED OR NON-EXISTENT BENEFIT. ON (B)(6) 2019, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿POSITIVE FOR CAVAL PERFORATION. SUPERIOR EXTENT OF IVC FILTER L3 VERTEBRAL BODY. INFERIOR EXTENT L4 VERTEBRAL BODY. A TOTAL OF 4 PRONGS HAVE PERFORATED THROUGH IVC. MAXIMUM DISTANCE PRONGS PERFORATED THROUGH IVC 3.63 MM. 4.72 DEGREE TILT SUPERIOR LEFT TO INFERIOR RIGHT.¿

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Perforation of Vessels; Scar Tissue; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 17596772 ↗
• InjuryJul 24, 2023Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2015 VIA THE RIGHT COMMON FEMORAL VEIN AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS (DVT) / PULMONARY EMBOLISM (PE). THE PATIENT ALLEGES TILT AND VENA CAVA PERFORATION. ON (B)(6) 2020, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿IVC FILTER WITH: TILTING WITH THE APEX AGAINST THE IVC WALL. 4 MM VERTEBRAL AND 3 MM MESENTERIC PERFORATION. NO FRACTURE, STENOSIS, OR MIGRATION.¿

  Patient problems: Internal Organ Perforation; Perforation of Vessels

  MAUDE report 17381014 ↗
• InjuryFeb 17, 2023Structural Problem; Appropriate Device Problem Term/Code Not Available; Structural Problem; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION PROVIDES THE PATIENT RECEIVED THE TULIP FILTER DUE TO DVT, HISTORY OF PE, AND HYPERCOAGULABILITY. PATIENT IS ALLEGING VENA CAVA PERFORATION. PATIENT ADDITIONALLY ALLEGES LIMITED PHYSICAL ACTIVITY.

  Patient problems: Insufficient Information; Perforation of Vessels

  MAUDE report 16397956 ↗
• InjuryFeb 1, 2023Obstruction of Flow; Structural Problem; Device Tipped Over; Obstruction of Flow; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2013 VIA THE RIGHT COMMON FEMORAL VEIN PRIOR TO PRE-BARIATRIC SURGERY. PATIENT'S REPRESENTATIVE IS ALLEGING VENA CAVA PERFORATION AND TILT. PATIENT REPRESENTATIVE ADDITIONALLY ALLEGES "ABDOMINAL TENDERNESS AND DISCOMFORT/ PAIN." DEPRESSION AND BLOOD CLOTS POST FILTER PLACEMENT. THE PATIENT REPORTEDLY EXPIRED (B)(6) 2021; HOWEVER, IT HAS NOT BEEN INDICATED THE DEVICE WAS A CONTRIBUTING FACTOR. PER COMPUTED TOMOGRAPHY REPORT, "INFRARENAL IVC FILTER IS IN PLACE WITH FILTER TIP 2.6 CM BELOW THE RENAL VEINS. THERE IS LATERAL TILT OF 16 DEGREES AND NO SIGNIFICANT ANTERIOR OR POSTERIOR TILT. THE FILTER TIP ABUTS THE POSTERIOR WALL OF THE IVC. NO STENOSIS. RIGHT AND LEFT LATERAL AND POSTERIOR STRUTS ARE LOCATED IMMEDIATELY EXTERNAL TO THE IVC WALL. ANTERIOR STRUT EXTENDS 6 MM INTO THE ADJACENT RETROPERITONEAL FAT." PER CERTIFICATE OF DEATH, DATED (B)(6) 2021: "IMMEDIATE CAUSE OF DEATH: COVID 19 INFECTION AND ATYPICAL PNEUMONIA, CONGESTIVE HEART FAILURE"

  Patient problems: Depression; Discomfort; Pain; Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 16276993 ↗
• InjuryDec 16, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 DUE TO PULMONARY EMBOLISM (PE). THE PATIENT ADDITIONALLY ALLEGES PERFORATION ABUTTING ORGAN. THE PATIENT FURTHER ALLEGES FEAR, ANXIETY, AND DEPRESSION. REPORTEDLY, THE PATIENT UNDERWENT PERCUTANEOUS FILTER REMOVAL SURGERY ON (B)(6) 2019 DUE TO NO LONGER NEEDED AND REQUESTED DUE TO THROMBOGENIC POSSIBILITIES DUE TO ANTIPHOSPHOLIPID SYNDROME. (B)(6) 2018, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿POSITIVE FOR CAVAL PERFORATION. SUPERIOR EXTENT OF IVC FILTER INFERIOR L2 VERTEBRAL BODY. INFERIOR EXTENT L3-L4 DISC. A TOTAL OF 4 PRONGS HAVE PERFORATED THE IVC. MAXIMUM DISTANCE PRONGS PERFORATED 5 MM. CORONAL IMAGES 5 DEGREE TILT LEFT TO RIGHT. SAGITTAL IMAGES 0 DEGREE TILT. DIAMETER OF IVC DIRECTLY ABOVE 10 MM X 14 MM. ATTENTION: PRONGS HAVE PERFORATED THE DUODENUM.¿. (B)(6) 2019, PER A REPORT FROM RETRIEVAL REPORT (SUCCESSFUL); "DURING THE PLACEMENT OF THE ["16 FR - 30CM"]SHEATH, THE PATIENT BECAME PROFOUNDLY BRADYCARDIC WITH A HEART RATE IN THE 20S, POSSIBLE DUE TO PRESSURE UPON THE CAROTID BULB WHILE TRYING TO ADVANCE THE LARGE SHEATH. ATROPINE WAS GIVEN WITH GOOD RESPONSE. THE PATIENT WAS STABILIZED IN THE PROCEDURE CONTINUED". "THE

  Patient problems: Anxiety; Bradycardia; Depression; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 15996509 ↗
• InjuryDec 6, 2022Structural Problem; Structural Problem

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2011 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO ACL IMPLANTED SURGERY PREPARATION. PATIENT IS ALLEGING VENA CAVA PERFORATION, AND FILTER ABUTS DUODENUM. PATIENT ALLEGES "STRESS, ANXIETY." DEPRESSION. PER COMPUTED TOMOGRAPHY (CT) REPORT, "THE INFERIOR VENA CAVA FILTER APPROPRIATELY POSITIONED BELOW THE RENAL VEINS. THERE IS NO EVIDENCE OF FILTER MIGRATION:. THE INFERIOR VENA CAVA REMAINS PATENT. THE ANTERIOR, POSTERIOR, MEDIAL AND LATERAL PORTIONS OF THE FILTER APPEAR TO PROTRUDE BEYOND THE LUMEN OF THE INFERIOR VENA CAVA. THE ANTERIOR PORTION OF THE FILTER ABUTS THE POSTERIOR MARGIN OF THE DUODENUM. THERE IS NO FILTER EROSION INTO THE AORTA."

  Patient problems: Anxiety; Depression; Perforation of Vessels

  MAUDE report 15924350 ↗
• InjuryDec 5, 2022Structural Problem; Structural Problem

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2013 DUE TO DEEP VEIN THROMBOSIS (DVT). PATIENT IS ALLEGING VENA CAVA PERFORATION. PATIENT ALLEGES "I LIVE WITH THE ANXIETY OF HAVING A FILTER THAT COULD FAIL FURTHER AT ANY TIME, BUT THAT CANNOT BE RETRIEVED WITHOUT A SERIOUS SURGERY. I AM WORRIED BECAUSE MY FILTER HAS PERFORATED OUTSIDE OF MY VENA CAVA." "FOR FEAR OF AGGRAVATING MY CURRENT CONDITION AND CAUSING POTENTIAL FUTURE INJURIES RELATED TO THE COOK FILTER, I TRY NOT TO ENGAGE IN ANY ACTIVITIES THAT COULD CAUSE ME TO EXERT MYSELF. THIS INCLUDES EVERYDAY LIFTING." PER COMPUTED TOMOGRAPHY REPORT, "CAVAL PERFORATION: YES. 10 O'CLOCK 7.00 MM GRADE 2."

  Patient problems: Anxiety; Perforation of Vessels

  MAUDE report 15915611 ↗
• MalfunctionSep 30, 2022Difficult to Remove; Unintended Movement; Difficult to Remove; Unintended Movement

  PATIENT ALLEGEDLY RECEIVED A TULIP IMPLANT ON (B)(6) 2012 VIA THE RIGHT FEMORAL VEIN DUE TO TRAUMA/MOTOR VEHICLE ACCIDENT. PATIENT IS ALLEGING UNABLE TO RETRIEVE. THE PATIENT FURTHER ALLEGES MIGRATION.

  Patient problems: Insufficient Information

  MAUDE report 15512681 ↗
• InjuryAug 30, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED THE GUNTHER TULIP FILTER VIA AN UNSPECIFIED COMMON FEMORAL VEIN ON (B)(6) 2015 DUE TO DEEP VEIN THROMBOSIS (DVT). PATIENT IS ALLEGING VENA CAVA PERFORATION. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING FEAR, "TROUBLE BREATHING, BED-RIDDEN, SITS IN A RECLINER ALL DAY, CANNOT GO ON WALKS WITHOUT EXERTING [SELF]" PER A COMPUTED TOMOGRAPHY (CT) ABDOMEN: "FILTER TYPE: COOK. IVC STENOSIS: NO. FILTER CONE POSITION: BELOW. FILTER MIGRATION: NO. FILTER FRACTURE/BENDING: NO. FILTER TILT: YES. FILTER PENETRATION: YES. OTHER FINDINGS: NO. IMPRESSIONS: THE FILTER IS TILTED SUCH THAT ITS CONE LIES ON THE ANTERIOR IVC WALL, AXIAL IMAGE 51. THE LEFT SIDED SUPPORT STRUT HAS PENETRATED 9 MM THROUGH THE IVC WALL, CORONAL IMAGE 58. THE POSTERIOR SUPPORT STRUT HAS PENETRATED 9 MM THROUGH THE IVC WALL, THE ANTERIOR STRUT IS 10 MM THROUGH THE IVC WALL". PER A CT ABDOMEN: "AN INFERIOR VENA CAVA FILTER IS NOTED WITH THE TIP AT THE LEVEL OF RENAL VEINS. THE LEGS ALONG THE MEDIAL WALL AND INFERIOR VENA CAVA UP APPEAR TO BE PROJECTING SLIGHTLY PAST OUTSIDE THE WALL OF THE INFERIOR VENA CAVA. THERE IS NO SURROUNDING INFLAMMATION".

  Patient problems: Ambulation or Postural Difficulties; Dyspnea; Perforation of Vessels

  MAUDE report 15325474 ↗
• MalfunctionAug 8, 2022Difficult to Remove; Difficult to Remove

  PATIENT ALLEGEDLY RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER VIA THE RIGHT COMMON FEMORAL VEIN ON (B)(6) 2011 DUE TO BARIATRIC SURGERY. THE PATIENT ALLEGES UNABLE TO BE REMOVED. THE PATIENT FURTHER ALLEGES CHEST PAINS, HEAVY FEELING IN CHEST, ANXIETY, AND LIMITED MOBILITY.

  Patient problems: Anxiety; Chest Pain

  MAUDE report 15186617 ↗
• InjuryAug 8, 2022Difficult to Remove; Structural Problem; Device Tipped Over; Difficult to Remove; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2011 VIA THE RIGHT FEMORAL VEIN DUE TO TRAUMA. PATIENT IS ALLEGING TILT, VENA CAVA PERFORATION, UNABLE TO RETRIEVE, AND EMBEDMENT (ENDOTHELIALIZATION). THE PATIENT FURTHER ALLEGES CONCERN REGARDING STRENUOUS PHYSICAL ACTIVITY, AS WELL AS STRESS AND ANXIETY. (B)(6) 2018, REPORT FROM CT (COMPUTED TOMOGRAPHY): ""THE INFERIOR VENA CAVA FILTER IS IDENTIFIED. THERE ARE FOUR PRONGS WHICH PROJECT OUTSIDE THE CONFINES OF THE INFERIOR VENA CAVA INDICATING THIS HAS BEEN COMPLETELY ENDOTHELIALIZED AND THE RISK OF ATTEMPTED REMOVAL WOULD FAR EXCEED THE REWARD. MORE IMPORTANTLY, THE SUPRARENAL, JUXTARENAL, AND INFRARENAL INFERIOR VENA CAVA ARE ALL WIDELY PATENT."

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

  MAUDE report 15184802 ↗
• InjuryJun 17, 2022Difficult to Remove; Structural Problem; Difficult to Remove; Structural Problem

  PATIENT ALLEGEDLY RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON 26AUG2012 VIA THE RIGHT FEMORAL VEIN DUE TO PULMONARY EMBOLISM. THE PATIENT ALLEGES VENA CAVA/ORGAN PERFORATIONS AND MULTIPLE RETRIEVAL PROCEDURES. THE PATIENT FURTHER ALLEGES ANXIETY, WORRY, FEAR, AND LIMIT ACTIVITIES. UNSUCCESSFUL PERCUTANEOUS FILTER REMOVAL ON (B)(6) 2019 DUE TO CONCERN OVER LONG-TERM COMPLICATIONS. PERCUTANEOUS (COMPLEX/LASER ASSISTED) FILTER REMOVAL ON (B)(6) 2020 DUE TO NO LONGER NEEDED. ON 10DEC2020, PER A REPORT FROM RETRIEVAL REPORT (SUCCESSFUL); ¿THE GUNTHER TULIP FILTER IN THE INFRARENAL IVC WAS RETRIEVED WITH THE ASSISTANCE OF A LASER APPLICATION TO FREE IT FROM THE WALL. THE REMOVED FILTER WAS INTACT.¿

  Patient problems: Anxiety; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 14735390 ↗
• InjuryJun 14, 2022Obstruction of Flow; Structural Problem; Device Tipped Over; Obstruction of Flow; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2011 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE). PATIENT IS ALLEGING VENA CAVA PERFORATION. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING ANXIETY, WORRY, PHYSICAL LIMITATIONS, AND POST FILTER PLACEMENT BLOOD CLOTS. PER A COMPUTED TOMOGRAPHY (CT) ABDOMEN/PELVIS: "CAVAL PERFORATION: GRADE 2 CAVAL PENETRATION AT 7 O'CLOCK. GRADE 1 CAVAL PENETRATION AT 1 O'CLOCK, 4 O'CLOCK AND 10 O 'CLOCK . TILT : YES 7.90 DEGREE LEFT LATERAL TILT. NO AP TILT. MIGRATION: NO. PERTINENT NEGATIVES: SEE BELOW. ADDITIONAL FINDINGS: LOCATION: TIP IS 1.5 CM BELOW THE RIGHT RENAL VEIN. NUMBER OF STRUTS 12. STRUT FRACTURE: NO".

  Patient problems: Anxiety; Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 14687288 ↗
• InjuryMay 19, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING FILTER PERFORATION OF ORGAN. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

  Patient problems: Anxiety; Depression; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 14444891 ↗
• InjuryMay 19, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING FILTER PERFORATION OF ORGAN. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

  Patient problems: Anxiety; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 14444687 ↗
• InjuryMay 19, 2022Structural Problem; Unintended Movement; Structural Problem; Unintended Movement

  IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING FILTER PERFORATION OF ORGAN. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

  Patient problems: Anxiety; Internal Organ Perforation; Pain; Perforation of Vessels

  MAUDE report 14444255 ↗
• InjuryMay 19, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING FILTER PERFORATION OF ORGAN. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

  Patient problems: Anxiety; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 14443982 ↗
• InjuryMay 19, 2022Difficult to Remove; Obstruction of Flow; Structural Problem; Device Tipped Over; Difficult to Remove; Obstruction of Flow; Structural Problem; Device Tipped Over

  IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING FILTER PERFORATION OF ORGAN. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

  Patient problems: Anxiety; Depression; Internal Organ Perforation; Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 14443766 ↗
• InjuryMay 19, 2022Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement

  IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING FILTER FRACTURE. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

  Patient problems: Anxiety; Insufficient Information; Pain; Perforation of Vessels

  MAUDE report 14443729 ↗
• MalfunctionApr 7, 2022Device Tipped Over; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED A GUNTHER TULIP IMPLANT ON (B)(6) 2012 VIA THE RIGHT FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE). PATIENT IS ALLEGING TILT. THE PATIENT FURTHER ALLEGES PAIN, ABDOMINAL PAIN WITH MOVEMENT, AND ANXIETY. REPORT FROM CT (COMPUTED TOMOGRAPHY): "CAVAL PERFORATION: NO. RELATION OF THE CAVAL FILTER TO THE IVC WALL IS GRADE 1 CONSISTENT WITH TENTING. TILT: YES. RIGHT-SIDED TILT MEASURING 8.95 DEGREES. POSTERIOR TILT MEASURING 3.69 DEGREES. MIGRATION: APEX OF THE CAVAL FILTER IS AT THE ORIGIN OF THE RIGHT RENAL VEIN."

  Patient problems: Abdominal Pain; Anxiety; Pain

  MAUDE report 14043857 ↗