Gunther Tulip G33017Recalls & reported problems
Cook Incorporated · Gunther Tulip Vena Cava Filter Set Jugular Approach · Class 2 · Implant
Quick summary
This Cook Gunther Tulip is a filter placed in the vena cava, a large vein, to catch blood clots. Many of its 286 reports describe the filter tilting, its struts perforating the vein wall or nearby organs, and the filter being hard to remove. The reports include 199 injuries and 3 deaths. No recalls name this device. The latest report is from July 2023.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 286
- Deaths reported
- 3
- Injuries reported
- 199
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 286 adverse event reports that list this exact device (DI 10827002330174), received between Aug 21, 2014 and Jul 28, 2023 — classified as 3 deaths, 199 injuries, 84 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (112 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
Device problems
- Difficult to Remove112
- Appropriate Device Problem Term/Code Not Available103
- Structural Problem75
- Unintended Movement59
- Device Tipped Over36
- Adverse Event Without Identified Device or Use Problem29
- Insufficient Device Problem Information25
- Migration or Expulsion of Device23
Patient problems
- Perforation of Vessels171
- Internal Organ Perforation67
- Pain56
- Anxiety52
- Vessel Or Plaque, Device Embedded In49
- Thrombosis36
- No Known Impact Or Consequence To Patient28
- Pulmonary Embolism28
Recent adverse event reports
The 25 most recent of 286 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT ALLEGEDLY RECEIVED TWO GUNTHER TULIP FILTERS ON (B)(6) 2014 DUE TO DEEP VEIN THROMBOSIS (DVT)/PULMONARY EMBOLISM (PE). THE PATIENT ALLEGES CHEST/BACK PAIN, IMPAIRED COGNITIVE FUNCTION, LIMITED MOBILITY, SHORTNESS OF BREATH, NUMBNESS OF EXTREMITIES, AND PAIN.
Patient problems: Chest Pain; Cognitive Changes; Dyspnea; Numbness; Pain
MAUDE report 17415964 ↗InjuryJul 25, 2023Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6)2011 VIA THE RIGHT INTERNAL JUGULAR VEIN. THE PATIENT ALLEGES ORGAN PERFORATION.
Patient problems: Internal Organ Perforation; Pain; Perforation of Vessels
MAUDE report 17391796 ↗InjuryJun 27, 2023Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available
THE PATIENT ALLEGEDLY RECEIVED AN IMPLANT (B)(6) 2010 VIA RIGHT INTERNAL JUGULAR VEIN TO POST DEEP VEIN THROMBOSIS (DVT). THE PATIENT ALLEGES TILT, VENA CAVA PERFORATION, AND ORGAN PERFORATION. (B)(6) 2021, PER A REPORT FROM COMPUTED TOMOGRAPHY 2; ¿IVC FILTER WITH: TILTING WITH THE APEX AGAINST THE IVC WALL. 3 MM MESENTERIC, 4 MM AORTIC, AND 5 MM SMALL.¿
Patient problems: Insufficient Information; Internal Organ Perforation; Perforation of Vessels
MAUDE report 17212817 ↗InjuryMay 24, 2023Difficult 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) 2014 VIA THE LEFT FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE), FOLLOWED BY A SUCCESSFUL, PERCUTANEOUS FILTER RETRIEVAL REQUIRING ADVANCED TECHNIQUES ON (B)(6) 2022. PATIENT IS ALLEGING VENA CAVA PERFORATION AND DEVICE TILT. (B)(6) 2022, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿INFRARENAL IVC FILTER IN PLACE. THERE IS TILTING OF THE IVC FILTER WITH EXTENSION OF THE STRUTS OUTSIDE THE WALL OF THE IVC. NO DEFINITE EVIDENCE OF FILTER FRACTURE.¿ (B)(6)2022, PER A REPORT FROM RETRIEVAL REPORT (SUCCESSFUL); ¿TECHNICALLY SUCCESSFUL INFERIOR VENA CAVA FILTER RETRIEVAL USING ADVANCED TECHNIQUES.¿
Patient problems: Perforation of Vessels
MAUDE report 16996068 ↗InjuryMay 4, 2023Structural 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 ON (B)(6)2010. APPROXIMATELY 10 YEARS AND 11 MONTHS LATER THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY SCAN. THE SCAN REVEALED THE IVC FILTER IS TILTED POSTERIORLY AND MEDIALLY AND THE HOOK CONTACTS THE IVC WALL. ALL THE STRUTS OF THE IVC FILTER PERFORATE THE IVC UP TO 15MM. ONE (1) ANTERIOR STRUT PERFORATES THE IVC WALL 13MM AND RESIDES WITHIN THE SOFT TISSUES. ONE (1) MEDIAL STRUT PERFORATES THE IVC WALL 14MM AND CONTACTS THE AORTA. ONE (1) POSTERIOR STRUT PERFORATES THE IVC WALL 15MM AND RESIDES WITHIN THE SOFT TISSUES. ONE (1) LATERAL STRUT PERFORATES THE IVC WALL 14MM AND RESIDES WITHIN THE SOFT TISSUES. THE PATIENT EXPERIENCED ANXIETY, FEAR, DEPRESSION, AND PAIN AS A RESULT OF THE INJURIES CAUSED BY THE FILTER. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED. PER COMPUTED TOMOGRAPHY REPORT,, "THE HOOK OF THE COOK GUNTHER TULIP RETRIEVABLE IVC FILTER IS AT THE L2-3 INTERSPACE. THE IVC FILTER IS TILTED POSTERIORLY AND MEDIALLY AND THE HOOK CONTACTS THE IVC WALL. ALL THE STRUTS OF THE IVC FILTER PERFORATE THE IVC UP TO 15MM. ONE (1) ANTERIOR STRUT PERF
Patient problems: Anxiety; Depression; Pain; Perforation of Vessels
MAUDE report 16869767 ↗InjuryDec 6, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2014 DUE TO BLOOD CLOTS. PATIENT IS ALLEGING VENA CAVA PERFORATION, AND PERFORATION ABUTTING STRUCTURES. 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, ABUTTING MY L3 PREVERTEBRAL SOFT TISSUES AND DUODENUM." "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." PER COMPUTED TOMOGRAPHY REPORT, "CAVAL PERFORATION: YES. 7 O'CLOCK 5.0 MM GRADE 3 EXTENDING TO THE L3 PERVERTEBRAL SOFT TISSUES. 11 O'CLOCK 4.9 MM GRADE 3 EXTENDING TO THE PERIPHERY OF THE DUODENUM." "TILT: YES. ANTERIOR TILT MEASURING 11.23 DEGREES."
Patient problems: Anxiety; Perforation of Vessels
MAUDE report 15924430 ↗InjurySep 15, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO DEEP VEIN THROMBOSIS (DVT). PATIENT IS ALLEGING MESENTERIC PERFORATION, AND TILT. PATIENT FURTHER ALLEGES "STRESS AND WORRY OF THE FILTER STILL BEING INSIDE OF ME AND WHAT COULD HAPPEN." "I CAN NO LONGER DO HEAVY LIFTING OR LONG WALKING, NOT SURE IF IT IS RELATED TO FILTER OR NOT." PER COMPUTED TOMOGRAPHY REPORT, "A TENT SHAPED INFERIOR VENA CAVA FILTER IS IDENTIFIED IN PLACE WITH HEAD LOCATED 3.5 CM BELOW THE LEVEL OF THE RIGHT RENAL VEIN LEVEL (THE LOWEST VEIN). IT HAS A LONG AXIS PARALLEL TO THE LONG AXIS OF THE INFERIOR VENA CAVA ON THE SAGITTAL AND CORONAL PROJECTIONS. THE FILTER HAS 4 INTERCONNECTED PERIPHERAL STRUTS DEMONSTRATING MILD TENTING OF THE IVC WALL CONSISTENT WITH GRADE 1 PERFORATION. NO FRACTURE OR DEFORMITY OF THE FILTER IS IDENTIFIED. THE INFERIOR VENA CAVA ABOVE AND BELOW THAT LEVEL IS OF NORMAL CALIBER."
Patient problems: Internal Organ Perforation
MAUDE report 15428474 ↗InjurySep 14, 2022Structural Problem; Structural Problem
THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2014. APPROXIMATELY 5 YEARS AND 11 MONTHS LATER A REVIEW OF THE PATIENT COMPUTED TOMOGRAPHY SCAN REVEALED THE IVC FILTER STRUTS PERFORATED THE IVC WALL UP TO 12MM WITH ONE STRUT CONTACTING THE BOWEL AND TWO STRUTS RESIDING IN SOFT TISSUES. PATIENT ALLEGEDLY RECEIVED THE GUNTHER TULIP FILTER VIA THE RIGHT JUGULAR VEIN DUE TO DEEP VEIN THROMBOSIS (DVT) OF THE LEG AND A LARGE PULMONARY EMBOLISM (PE) WITH HYPOTENSION AND CARDIOVASCULAR COMPROMISE. PATIENT IS ALLEGING VENA CAVA AND ORGAN PERFORATION. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING "MENTALLY HINDERED FROM PERFORMING REGULAR DUTY, EXERCISE, FEAR OF WHAT COULD HAPPEN IF DOING NORMAL EVERYDAY ACTIVITIES"; WEIGHT INCREASE, RELATIONSHIP ISSUES. PER A COMPUTED TOMOGRAPHY (CT) ABDOMEN AND PELVIS: "THE HOOK OF THE COOK GUNTHER TULIP RETRIEVABLE IVC FILTER IS AT THE L1-2 INTERSPACE. THE IVC FILTER IS NOT TILTED. ALL THE STRUTS OF THE IVC FILTER PERFORATE THE IVC UP TO 12MM. ONE (1) ANTERIOR STRUT PERFORATES THE IVC WALL 12MM AND CONTACTS THE BOWEL. ONE (1) MEDIAL STRUT PERFORATES THE IVC WALL 7MM AND CONTACTS THE BO
Patient problems: Internal Organ Perforation; Perforation of Vessels; Unspecified Mental, Emotional or Behavioral Problem; Weight Changes
MAUDE report 15421190 ↗InjurySep 14, 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 ON (B)(6) 2013. APPROXIMATELY 5 YEARS AND 11 MONTHS LATER, THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN. THE PATIENT WAS INFORMED THAT THE STRUTS OF THE FILTER HAD PERFORATED THROUGH THE IVC WALL, PARTICULARLY THE ANTERIOR STRUT, WHICH HAD EXTENDED 4 MM BEYOND THE WALL OF THE INFERIOR VENA CAVA. ADDITIONAL INFORMATION PROVIDED THE PATIENT RECEIVED THE GUNTHER TULIP FILTER VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO DEEP VEIN THROMBOSIS. PATIENT IS ALLEGING DEVICE TILT, VENA CAVA AND ORGAN PERFORATION. THE PATIENT NOTES AND FURTHER ALLEGES "THE FILTER IS TILTED WITH STRUTS PERFORATING MORE THAN 3MM OUTSIDE THE IVC. ONE STRUT APPEARS TO PENETRATE THE DUODENUM"; PAIN UPON RAISING ARMS UP AND DOWN.
Patient problems: Internal Organ Perforation; Pain; Perforation of Vessels
MAUDE report 15420266 ↗MalfunctionAug 25, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(4) 2014 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO VEIN THROMBOSIS AND PULMONARY EMBOLISM (PE). THE PATIENT ALLEGES SHORTNESS OF BREATH, CHEST PAIN, NUMBNESS, BACK PAIN, IMPAIRED COGNITIVE FUNCTION, AND LIMITED MOBILITY.
Patient problems: Chest Pain; Cognitive Changes; Dyspnea; Pain
MAUDE report 15294869 ↗MalfunctionJun 20, 2022Obstruction of Flow; Unintended Movement; Obstruction of Flow; Unintended Movement
PATIENT ALLEGEDLY RECEIVED A GUNTHER TULIP IMPLANT ON (B)(6) 2012 DUE TO BLOOD CLOTS. PATIENT IS ALLEGING MIGRATION. THE PATIENT FURTHER ALLEGES BACK AND ABDOMINAL PAIN, PAIN WHILE SLEEPING, PHYSICAL LIMITATIONS, AND POST-IMPLANT DEEP VEIN THROMBOSIS (DVT). REPORT FROM CT (COMPUTED TOMOGRAPHY): "CAVAL PERFORATION: NO. RELATION OF CAVAL FILTER TO THE IVC WALL IS GRADE 1 CONSISTENT WITH TENTING. TILT: NO. MIGRATION: YES. CAVAL FILTER IS IN A LOW POSITION WITH ITS INFERIOR ASPECT AT THE BIFURCATION."
Patient problems: Pain; Thrombosis/Thrombus
MAUDE report 14743423 ↗InjuryJun 13, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over
PATIENT ALLEGEDLY RECEIVED A GUNTHER TULIP IMPLANT ON (B)(6) 2015 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO THROMBOEMBOLIC DISEASE AND CONTRAINDICATION TO ANTICOAGULATION WITH UPCOMING SURGERY. PATIENT IS ALLEGING VENA CAVA PERFORATION AND ORGAN ABUTMENT. THE PATIENT FURTHER ALLEGES ANXIETY, WORRY, FEAR, LIMITED PHYSICAL ACTIVITY. REPORT FROM CT (COMPUTED TOMOGRAPHY): "CAVAL PERFORATION: GRADE 1 CAVAL PENETRATION AT 12 O'CLOCK. GRADE 2 CAVAL PENETRATION AT 7 O'CLOCK. GRADE 3 ORGAN ABUTMENT WITH THE AORTA AT 5 O'CLOCK. TILT: YES, NO SIGNIFICANT LATERAL TILT. 13.20 DEGREE AP TILT. MIGRATION: NO. PERTINENT NEGATIVES: SEE BELOW. ADDITIONAL FINDINGS: LOCATION: 1 CM BELOW THE RENAL VEIN. NUMBER OF STRUTS 8. STRUT FRACTURE: ABSENT."
Patient problems: Anxiety; Perforation of Vessels
MAUDE report 14676168 ↗InjuryMay 19, 2022Structural Problem; Structural Problem
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: Internal Organ Perforation
MAUDE report 14444686 ↗InjuryMay 19, 2022Structural Problem; Device Tipped Over; Unintended Movement; Structural Problem; Device Tipped Over; Unintended Movement
IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING PERFORATION OF IVC. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
Patient problems: Abdominal Pain; Depression; Eye Injury; Perforation; Perforation of Vessels
MAUDE report 14444563 ↗InjuryMay 19, 2022Structural Problem; Structural Problem
IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING PERFORATION OF IVC. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
Patient problems: Perforation of Vessels
MAUDE report 14444492 ↗InjuryMay 19, 2022Structural Problem; Structural Problem
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: Internal Organ Perforation
MAUDE report 14444405 ↗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; Device Embedded In Tissue or Plaque; Internal Organ Perforation; Perforation of Vessels
MAUDE report 14444276 ↗InjuryMay 19, 2022Structural Problem; Structural Problem
IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING PERFORATION OF IVC. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
Patient problems: Perforation of Vessels
MAUDE report 14444184 ↗InjuryMay 19, 2022Structural Problem; Structural Problem
IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING FILTER EMBOLIZATION/EMBEDMENT. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
Patient problems: Device Embedded In Tissue or Plaque; Embolism/Embolus
MAUDE report 14443920 ↗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 PERFORATION OF IVC. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
Patient problems: Anxiety; Perforation of Vessels
MAUDE report 14443882 ↗InjuryMay 19, 2022Structural Problem; Structural Problem
IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING PERFORATION OF IVC. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
Patient problems: Perforation of Vessels
MAUDE report 14443770 ↗InjuryMay 19, 2022Inadequate Filtration Process; Obstruction of Flow; Detachment of Device or Device Component; Inadequate Filtration Process; Obstruction of Flow; Detachment of Device or Device Component
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; Pulmonary Embolism; Thrombosis/Thrombus
MAUDE report 14443606 ↗InjuryMay 19, 2022Structural Problem; Structural Problem
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 14443575 ↗InjuryApr 22, 2022Structural Problem; Structural Problem
PATIENT ALLEGEDLY RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER IMPLANT ON (B)(6) 2013 VIA THE RIGHT INTERNAL JUGULAR VEIN FOR PROPHYLAXIS PRIOR TO SURGERY. APPROXIMATELY SIX YEARS AND SIX MONTHS LATER, IT WAS NOTED THAT THE IVC FILTER PENETRATED THE VENA CAVA, SEVERAL STRUTS EXTENDED BEYOND THE IVC WALL. PATIENT IS ALLEGING ORGAN/ VENA CAVA PERFORATION. PATIENT FURTHER ALLEGES "7MM OF PERFORATION OF THE FILTER PRONGS INTO THE ADJACENT MESENTERY." DEPRESSION. PER COMPUTED TOMOGRAPHY REPORT, "IN THE ABDOMEN THERE IS AN IVC FILTER, THIS ABUTS THE RIGHT LATERAL WALL OF THE INFERIOR VENA CAVA, ITS TIP IS ROUGHLY 7 MM INFERIOR TO THE RIGHT RENAL VEIN. THE PRONGS APPEAR TO BE INTACT THERE IS ROUGHLY 7 MM OF PERFORATION OF THE PRONGS INTO THE ADJACENT MESENTERY, THERE IS NO DEFINITE PERFORATION INTO ADJACENT ORGANS."
Patient problems: Depression; Internal Organ Perforation; Perforation of Vessels
MAUDE report 14187532 ↗InjuryApr 18, 2022Difficult to Remove; Structural Problem; Device Tipped Over; Unintended Movement; Difficult to Remove; Structural Problem; Device Tipped Over; Unintended Movement
PATIENT ALLEGEDLY RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2013 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO DIAGNOSED WITH DEEP VEIN THROMBOSIS (DVT)/PULMONARY EMBOLISM (PE). APPROXIMATELY 6 YEARS AND 6 MONTHS LATER THE PATIENT HAD A COMPUTED TOMOGRAPHY SCAN OF THE ABDOMEN AND PELVIS, WHICH REVEALED THE FILTER LEFT A GRADE 3 PERFORATION WITH A STRUT EXTENDING 5MM OUTSIDE THE CAVA WALL AND EMBEDDED IN THE LEFT LATERAL WALL OF THE AORTA. THE FILTER HAS ALSO MIGRATED 24MM. THE PATIENT HAD NO INDICATION THAT THE FILTER CAUSED THEIR ABDOMINAL AND LOWER BACK PAIN. THE PATIENT HAS ENDURED PHYSICAL PAIN AND SUFFERING, MENTAL ANGUISH, LOSS OF ENJOYMENT OF LIFE, AND OTHER LOSSES, SOME OF WHICH ARE PERMANENT IN NATURE. THE PATIENT ALLEGES DEVICE MIGRATION, TILT, VENA CAVA PERFORATION, AND UNABLE TO BE RETRIEVED. THE PATIENT FURTHER ALLEGES CHEST/NECK PAIN.
Patient problems: Abdominal Pain; Chest Pain; Device Embedded In Tissue or Plaque; Pain; Perforation of Vessels
MAUDE report 14134962 ↗
Other FILTER, INTRAVASCULAR, CARDIOVASCULAR devices
- Denali® Vena Cava Filter DL900FBard Peripheral Vascular, Inc. · FILTER, INTRAVASCULAR, CARDIOVASCULAR22 deaths529 reports
- DENALI® Vena Cava Filter DL900JBard Peripheral Vascular, Inc. · FILTER, INTRAVASCULAR, CARDIOVASCULAR15 deaths492 reports
- Option Elite Retrievable Vena Cava Filter System 352506070EArgon Medical Devices, Inc. · Filter, Intravascular, Cardiovascular2 recalls3 deaths342 reports
- Gunther Tulip G33016Cook Incorporated · FILTER, INTRAVASCULAR, CARDIOVASCULAR3 deaths348 reports
- Cook Celect G34309William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall1 death230 reports
- Gunther Tulip G52916William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall2 deaths189 reports
- Cook Celect G34502William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall2 deaths165 reports
- Cook Celect G34505William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall1 death131 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.