Gunther Tulip G21360Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10827002213606), received between Oct 25, 2016 and Feb 7, 2023 — classified as 1 death, 43 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (18 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2023Difficult to Remove; Structural Problem; Unintended Movement; Difficult to Remove; Structural Problem; Unintended Movement

  ORIGINAL: 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 ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2016 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE), FOLLOWED BY AN UNSUCCESSFUL PERCUTANEOUS RETRIEVAL ATTEMPT ON (B)(6) 2016. PATIENT IS ALLEGING VENA CAVA PERFORATION AND PERFORATION ABUTTING STRUCTURES. PATIENT FURTHER ALLEGES ANXIETY, DEPRESSION, WORRY, FEAR, AND LIMITED PHYSICAL ACTIVITY. REPORT FROM CT (COMPUTED TOMOGRAPHY): "FINDINGS: THIS DICTATION REFERS ONLY TO THE IVC FILTER. COOK GUNTHER TULIP FILTER. CAVAL PERFORATION: YES. 9 O'CLOCK 12.30 MM GRADE 2. 11 O'CLOCK 4.10 MM GRADE 3 EXTENDING TO THE PERIPHERY OF THE DUODENUM. 7 O'CLOCK 7.80 MM GRADE 2. TILT: NO. MIGRATION: YES. APEX OF THE CAVAL FILTER IS AT THE LEVEL OF THE RENAL VEINS. PERTINENT NEGATIVES: NONE."

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

  MAUDE report 16311460 ↗
• InjuryAug 17, 2022Difficult to Remove; Device Tipped Over; Difficult to Remove; Device Tipped Over

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE FILTER WAS SEVERELY TILTED AND COULD NOT NORMALLY BE RECOVERED FOR THE PATIENT . ON (B)(6) 2022, THE PATIENT UNDERWENT INFERIOR VENA CAVA ANGIOGRAPHY AND VENA CAVA FILTER IMPLANTATION. ON (B)(6) 2022, REMOVAL OF THE FILTER AFTER THE FILTER IMPLANTED 7 WEEKS. THE USER REPEATED ATTEMPTS BUT STILL FAILED TO RETRIEVE THE FILTER. THEN THE USER CORRECTED THE POSITION OF FILTER PROPERLY USING LOOP CATHETER, THE RECOVERY HOOK OF FILTER STILL COULD NOT BE CAPTURED. AT LAST, THE USER REMOVED THE FILTER RETRIEVE SET AND DECIDED TO RETRIEVE THE FILTER ANOTHER DAY. 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 15238461 ↗
• InjuryMay 19, 2022Structural Problem; Structural Problem

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

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14444509 ↗
• InjuryMay 19, 2022Structural Problem; Structural Problem

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

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14444356 ↗
• InjuryFeb 16, 2022Obstruction of Flow; Structural Problem; Obstruction of Flow; Structural Problem

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 DUE TO DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE). PATIENT IS ALLEGING VENA CAVA AND ORGAN PERFORATION. THE PATIENT FURTHER ALLEGES "MULTIPLE PRONGS OF THE IVC FILTER IMPLANTED IN MY BODY HAVE PERFORATED MY IVC. FURTHER, ONE PRONG OF THE FILTER IS PERFORATING MY ABDOMINAL AORTA," AS WELL AS ANXIETY, WORRY, POST-IMPLANT DVT, FEAR, AND PHYSICAL LIMITATIONS. REPORT FROM CT (COMPUTED TOMOGRAPHY): "IVC FILTER IS PRESENT: LOCATION: AT THE RENAL VEINS STRUT CAVAL PENETRATION: PRESENT AT 12 O'CLOCK AND 3 O'CLOCK. STRUT ORGAN PENETRATION: PRESENT INVOLVING THE ABDOMINAL AORTA. STRUT FRACTURE: ABSENT."

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

  MAUDE report 13546522 ↗
• InjuryFeb 8, 2022Obstruction of Flow; Device Tipped Over; Obstruction of Flow; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2011 PROPHYLACTICALLY. PATIENT IS ALLEGING TILT AND OCCLUSION. PATIENT FURTHER ALLEGES "THE COOK GUNTER TULIP FILTER REMAINS IN [PATIENT'S] BODY. [PATIENT] HAS EXPERIENCED PHYSICAL PAIN, MENTAL ANGUISH, EMOTIONAL DISTRESS AND PHYSICAL IMPAIRMENT IN THE PAST AND THESE ISSUES CONTINUE AS [PATIENT] FEARS THAT THE FILTER MAY FRACTURE, MIGRATE AND PERFORATE OTHER ORGANS AND CAUSE SERIOUS INJURY OR DEATH. [PATIENT] FURTHER STATES THAT THE IVC FILTER IS CLOGGED." PATIENT CAN NO LONGER ENGAGE IN "DAILY EXERCISE, I¿M OUT OF BREATH WHEN WALKING." PER BILATERAL VENOGRAM REPORT, "COMMON FEMORAL VEIN IS 100% OCCLUDED AND HAS A VERY SMALL CHANNEL LEADING TO THE IVC." "CONCLUSION: BILATERAL CTO OF COMMON FEMORAL VEIN. TOTAL OCCLUSION OF IVC FILTER".

  Patient problems: Emotional Changes; Obstruction/Occlusion; Pain

  MAUDE report 13483438 ↗
• InjuryFeb 7, 2022Structural Problem; Device Tipped Over; Unintended Movement; 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 LEFT FEMORAL ILIAC DEEP VEIN THROMBOSIS (DVT). PATIENT IS ALLEGING VENA CAVA PERFORATION. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING "ANXIETY", WORRY, AND PHYSICAL LIMITATIONS.

  Patient problems: Anxiety; Perforation of Vessels

  MAUDE report 13477146 ↗
• InjuryNov 11, 2021Structural Problem; Structural Problem

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO MULTIPLE TRAUMA, HIGH RISK FOR DEEP VEIN THROMBOSIS (DVT), AND PULMONARY EMBOLISM (PE). THE PATIENT ALLEGES VENA CAVA AND ORGAN PERFORATION. THE PATIENT FURTHER ALLEGES ANXIETY, WORRY, FEAR, AND LIMITED MOBILITY. THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2012. THE GUNTHER TULIP FILTER HAS PERFORATED THE IVC, FURTHER PERFORATING THE L3 VERTEBRAL BODY.

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

  MAUDE report 12796113 ↗
• MalfunctionOct 29, 2021Device Tipped Over; Device Tipped Over

  ADDITIONAL INFORMATION RECEIVED 03NOV2021: THE DISTRIBUTOR LEARNED THAT THE FILTER WAS IMPLANTED ON (B)(6) 2021 AND ANGIOGRAPHY FOUND THAT THE FILTER WAS TILTED AFTER IMPLANTATION. ON (B)(6) 2021 THE FILTER WAS REMOVED. AFTER THE FILTER WAS REMOVED, THE PATIENT'S CONDITION WAS STABLE AND NO OBVIOUS ABNORMALITY WAS OBSERVED. HE WAS DISCHARGED ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12718094 ↗
• InjurySep 22, 2021Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED A COOK TULIP FILTER IMPLANT ON (B)(6) 2014 VIA THE RIGHT FEMORAL VEIN DUE TO AN UPCOMING BARIATRIC PROCEDURE. PATIENT IS ALLEGING VENA CAVA PERFORATION. THE PATIENT FURTHER ALLEGES ANXIETY, WORRY, FEAR, AND PHYSICAL LIMITATIONS. IMPLANT REPORT: "USING ULTRASOUND GUIDANCE, THE RIGHT FEMORAL VEIN WAS IDENTIFIED." "THE WIRE WAS THEN REMOVED AND WE PLACED THE FILTER MECHANISM INTO THE 11-FRENCH SHEATH AND WE THEN UN-SHEATHED THE FILTER AND THEN THE FILTER WAS DEPLOYED. THE FILTER WAS NOTED TO BE IN GOOD POSITION BELOW THE RENALS AND THERE WAS MINIMAL TILT TO THE FILTER."

  Patient problems: Anxiety; Perforation of Vessels

  MAUDE report 12512055 ↗
• InjurySep 8, 2021Difficult to Remove; Obstruction of Flow; Structural Problem; Difficult to Remove; Obstruction of Flow; Structural Problem

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 PROPHYLACTICALLY. PATIENT IS ALLEGING VENA CAVA PERFORATION, DEVICE IS UNABLE TO BE RETRIEVED. PATIENT FURTHER ALLEGES PHYSICAL PAIN, MENTAL ANGUISH, EMOTIONAL DISTRESS, PHYSICAL IMPAIRMENT, FEAR.

  Patient problems: Emotional Changes; Pain; Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 12442537 ↗
• InjuryAug 30, 2021Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  NO ADDITIONAL EVENT INFORMATION.

  Patient problems: Anxiety; Perforation of Vessels

  MAUDE report 12385768 ↗
• InjuryAug 23, 2021Activation Failure; Activation Failure

  ACCORDING TO INITIAL REPORTER: PUNCTURE OF THE RIGHT FEMORAL VEIN THEN INSERT THE SHEATH, AND ADVANCED THE PIG TAIL CATHETER FOR INFERIOR VENA CAVA ANGIOGRAPHY. THERE WAS NO THROMBOSIS FOUND AT THE END OF IVC AND THE BLOOD FLOW WAS SMOOTH. THEN THE PHYSICIAN ADVANCED THE WIRE GUIDE AND DELIVERY SYSTEM INTO THE PATIENT. THE PHYSICIANS PLAN WAS TO DEPLOY THE FILTER AT THE POSITION OF BELOW RENAL VEIN THROUGH PERSPECTIVE AND TRACKING FUNCTION. WITHDRAW THE DELIVERY SHEATH FIRST, THEN UNSCREW THE RED SAFETY VALVE, AND FIX THE END HANDLE OF THE FILTER ,THEN WITHDRAW THE SHEATH TO RELEASE THE FILTER. BUT THE FILTER HAVE NOT COMPLETELY POP-UP. AFTER REPEATED OPERATIONS, THE FILTER CANNOT BE RELEASED NORMALLY AND THE SHEATH CANNOT BE WITHDRAWN. FINALLY, THE FILTER IS RECOVERED THROUGH THE JUGULAR VEIN. AFTER THE HOOK OF THE FILTER WAS PUT ON, THE SHEATH WAS PUSHED TO RETRACT THE FILTER. REPEATED ATTEMPTS WERE MADE TO RECOVER THE FILTER SUCCESSFULLY. CHECK THAT THE RECOVERED FILTER WAS DEFORMED, AND FINALLY RE-PLACE ANOTHER SET OF FILTER AND RELEASE SUCCESSFULLY. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352241 ↗
• InjuryApr 27, 2021Difficult to Remove; Structural Problem; Device Tipped Over; Difficult to Remove; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2013 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. PATIENT IS ALLEGING TILT, DEVICE IS UNABLE TO RETRIEVE, ORGAN PERFORATION. PATIENT FURTHER ALLEGES PAIN THROUGHOUT BODY, DISCOMFORT, STRESS, FEAR, PHYSICAL LIMITATIONS.

  Patient problems: Discomfort; Internal Organ Perforation; Pain

  MAUDE report 11732138 ↗
• InjuryJan 19, 2021Difficult to Remove; Obstruction of Flow; Device Tipped Over; Difficult to Remove; Obstruction of Flow; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2011 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO DEEP VEIN THROMBOSIS (DVT) FOLLOWED BY AN UNSUCCESSFUL, PERCUTANEOUS FILTER REMOVAL ATTEMPT (B)(6) 2018. PATIENT IS ALLEGING TILT, VENA CAVA PERFORATION, DEVICE IS UNABLE TO RETRIEVED, FILTER HOOK EMBEDDED IN VENA CAVA. PATIENT FURTHER ALLEGES FEAR, FILTER NOT REMOVED, FAILED REMOVAL ATTEMPT, WONT LIFT ARMS OVER HEAD, POPPING SOUND IN CHEST, ANXIETY, DEPRESSION. RETRIEVAL REPORT (ATTEMPTED): "ATTEMPTED RETRIEVAL OF A VENA CAVA FILTER." "CT IMAGING DEMONSTRATED THAT THE LEGS OF THE FILTER APPEARED TO BE EXTENDING BEYOND THE WALLS OF THE INFERIOR VENA CAVA AND THAT THE HOOK WAS TILTED IN PERHAPS WITHIN THE WALL OR SOME THROMBUS, BUT THERE DID NOT APPEAR TO BE A SIGNIFICANT AMOUNT OF THROMBUS WITHIN THE INFERIOR VENA CAVA." "A TOTAL OF 2-1/2 HOURS WAS SPENT TRYING TO RETRIEVE THIS FILTER ULTIMATELY WITHOUT SUCCESS". "AT THIS POINT, WE BOTH AGREED THAT NO FURTHER OPTIONS WERE GOING TO BE SUCCESSFUL AND THAT POSSIBLY COMING BACK WITH A LONG 16-FRENCH SHEATH AND RETRIEVAL FORCEPS MIGHT ALLOW US TO REPOSITION THE FILTER, SO THAT IT COULD BE CAPTURED OR AT LEAST REMOVE SOME OF THE SURROUNDING CH

  Patient problems: Perforation of Vessels; Thrombosis; Vessel Or Plaque, Device Embedded In

  MAUDE report 11194739 ↗
• InjuryNov 23, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: AFTER THE FILTER WAS IMPLANTED, THE RADIOGRAPHY SHOWED A BEND IN ONE OF THE PRIMARY LEG. THE FILTER WAS THEN RETRIEVED WITH A RETRIEVAL SET. A NEW FILTER WAS PLACED FOR THE PATIENT TO COMPLETE THE PROCEDURE. 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 Consequences Or Impact To Patient

  MAUDE report 10883739 ↗
• InjuryNov 20, 2020Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2014 DUE TO DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE). THE PATIENT ALLEGES ORGAN PERFORATION, VENA CAVA PERFORATION, AND TILT. THE PATIENT FURTHER ALLEGES POOR BLOOD FLOW, LEGS/ARM/HAND NUMBNESS, SEVERE HEADACHES, PAIN WHILE STANDING/WALKING, LIMITED MOBILITY, DEPRESSION, AND ANXIETY. ON (B)(6) 2019, REPORT FROM COMPUTED TOMOGRAPHY; ¿THE IVC FILTER IS POSITIONED WITHIN THE INFERIOR VENA CAVA IMMEDIATELY BELOW THE LEVEL OF THE RENAL VEINS. IT HAS AN 5 DEGREE RIGHTWARD TILT WITH PENETRATION OF THE 2 DEVICE STRUTS LOCATED ALONG THE LEFT SIDE OF THE DEVICE THROUGH THE WALL OF THE INFERIOR VENA CAVA. THE TIP OF THE MORE ANTERIOR PENETRATED STRUT ABUTS THE WALL OF A SEGMENT OF SMALL BOWEL AND THE TIP OF THE MORE POSTERIOR PENETRATED STRUT ABUTS THE WALL OF THE MID INFRARENAL ABDOMINAL AORTA. THERE IS NO EVIDENCE OF THROMBUS WITHIN THE INFERIOR VENA CAVA, COMMON ILIAC VEINS, EXTERNAL ILIAC VEINS OR COMMON FEMORAL VEINS.¿

  Patient problems: Internal Organ Perforation; Perforation of Vessels; Vascular System (Circulation), Impaired

  MAUDE report 10876146 ↗
• InjuryNov 19, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION 16DEC2020: FILTER WAS PLACED FROM JUGULAR APPROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10866277 ↗
• InjurySep 17, 2020Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2014 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO FREE FLOATING THROMBUS. PATIENT IS ALLEGING TILT, VENA CAVA PERFORATION, ORGAN PERFORATION. PATIENT FURTHER ALLEGES CHRONIC LEG SWELLING AND PAIN, PERSISTENT CHEST PAIN AND SHORTNESS OF BREATH, CHRONIC ABDOMINAL PAIN; CHRONIC LOWER BACK PAIN, SLOWED BLOOD FLOW AND PHYSICAL LIMITATIONS. REPORT ROM RADIOLOGY: "THE ANTERIOR MOST FILTER STRUT IS SEEN PIERCING (11.32MM) THE ANTERIOR WALL OF IVC AND. NO EVIDENCE OF FILTER BREAKAGE IMPINGING THE DUODENUM ANTERIORLY. THE MEDIAL FILTER STRUT IS SEEN PIERCING (10.27MM) THE MEDIAL WALL OF IVC AND IMPINGING THE AORTA MEDIALLY. THE LATERAL FILTER STRUT IS SEEN PIERCING (10.35MM) THE LATERAL WALL OF IVC AND IMPINGING THE BOWELS LATERALLY. THE POSTERIOR FILTER STRUT IS SEEN PIERCING (19.11MM) THE POSTERIOR WALL OF IVC AND IMPINGING THE PREVERTEBRAL STRUCTURES POSTERIORLY. THE FILTER APPEARS TILTED POSTERIORLY (15.63 DEG)."

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

  MAUDE report 10550444 ↗
• InjuryJun 10, 2020Structural Problem; Structural Problem

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

  Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10137101 ↗
• MalfunctionMay 11, 2020Sharp Edges; Sharp Edges

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE USER FELT RESISTANCE DURING THE PROCESS OF ADVANCING THE DELIVERY SYSTEM, THEN REMOVED THE DEVICE AND FOUND THE SHEATH WAS PUNCTURED BY ONE OF THE PRIMARY LEGS. THE USER CHANGED TO ANOTHER NEW DEVICE TO COMPLETED THIS 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 Consequences Or Impact To Patient

  MAUDE report 10042422 ↗
• InjuryApr 23, 2020Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO POST DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM. PER AN (B)(6) 2016 COMPUTED TOMOGRAPHY (CT) ANGIOGRAM PULMONARY ARTERIES: "FINDINGS: PULMONARY ARTERIES: FILLING DEFECT IS SEEN IN THE RIGHT LOWER LOBE SEGMENTAL AND SUBSEGMENTAL BRANCHES (SERIES 5, IMAGES 61 THROUGH 72) CONSISTENT WITH PULMONARY EMBOLUS". PER A (B)(6) 2016 REPORT FROM COMPUTED TOMOGRAPHY; ¿FINDINGS: VESSELS: THERE IS AN IVC FILTER IN PLACE. TIP OF THE IVC FILTER IS BELOW THE RENAL VEINS. TWO OF THE LEGS SLIGHTLY PROTRUDE OUTSIDE THE IVC. HOWEVER, THERE IS NO EVIDENCE FOR FISTULA. NO SURROUNDING SOFT TISSUE STRANDING.¿ ¿IMPRESSION: PULMONARY ANGIOGRAM, THROMBOLYSIS AND PLACEMENT OF BILATERAL LOWER LOBE PULMONARY ARTERY EKOS THROMBOLYSIS CATHETERS. PULMONARY ARTERY PRESSURES WERE MODERATE TO SEVERELY ELEVATED MEASURING 48/21 WITH A MEAN OF 33 MMHG. VENACAVOGRAM DEMONSTRATED NO EVIDENCE OF THROMBUS ON THE TOP OF THE EXISTING IVC FILTER. DESPITE THE LACK OF THROMBUS OVER THE FILTER, LIKELY THE THROMBUS AROSE FROM THIS LOCATION GIVEN THE VOLUME OF THROMBUS IN THIS ACUTE PE.¿ PER A (B)(6) 2016 FOLLOW-UP BILATERAL PULMONARY ARTER

  Patient problems: Pain; Perforation of Vessels; Pulmonary Embolism; Thrombus

  MAUDE report 9990433 ↗
• InjuryApr 15, 2020Activation Failure; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PRIOR TO USE, THE PHYSICIAN CHECKED THE FILTER AND NO ABNORMALITY WAS FOUND IN VITRO. THEN THE PHYSICIAN ADVANCED THE FILTER FOLLOWING THE STEPS AND INSTRUCTION. AFTER REACH TO THE TARGET LOCATION THE PHYSICIAN RELEASED THE FILTER, BUT UNDER THE RAY, THE USER FOUND THE SHAPE OF THE FILTER WAS ABNORMAL. IMMEDIATELY, THE PHYSICIAN RETRIEVED THE FILTER BY (B)(4) THROUGH JUGULAR VEIN SUCCESSFULLY. THE PHYSICIAN REPLACED ANOTHER SET OF FILTER AND PLACED IN THE PATIENT SUCCESSFULLY. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9961701 ↗
• InjuryApr 2, 2020Difficult to Remove; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Appropriate Device Problem Term/Code Not Available

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2014 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO PULMONARY EMBOLISM (PE). PATIENT IS ALLEGING VENA CAVA PERFORATION AND THE DEVICE IS UNABLE TO BE RETRIEVED. ON 27JUN2019, PER A REPORT FROM COMPUTED TOMOGRAPHY (CT); ¿FINDINGS: THERE IS AN IVC FILTER IN PLACE. FILTER IS JUST BELOW THE RENAL VEINS IN GOOD POSITION. THE LEGS OF THE IVC FILTER EXTEND BEYOND THE LUMEN OF THE IVC. ONE FILTER LEG CONTACTS THE AORTA ALTHOUGH IT DOES NOT DEFINITELY PENETRATE THE AORTA. THERE IS NO THROMBUS IN THE FILTER OR IVC. THERE IS FUSIFORM ANEURYSMAL DILATION OF THE INFRARENAL ABDOMINAL AORTA MEASURING UP TO 33 X 38 MM WITH SOME INDISTINCTNESS OF THE LEFT LATERAL WALL AND A NIPPLE-LIKE APPEARANCE.¿

  Patient problems: Perforation of Vessels

  MAUDE report 9916093 ↗
• InjuryFeb 25, 2020Insufficient Device Problem Information

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2015 VIA THE RIGHT GROIN. NO ALLEGATIONS HAVE BEEN RECEIVED.

  Patient problems: No Information

  MAUDE report 9751386 ↗