TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator 466P306AURecalls & reported problems

Summary

The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 20705032009451), received between Aug 14, 2017 and Sep 16, 2022 — classified as 6 deaths, 180 injuries.

The most frequently reported specific device problem is “Unintended Movement” (71 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 186 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO FILTER IS TILTED ANTERIORLY AT THE SUPERIOR END. THE FILTER IS TILTED POSTERIORLY AT THE INFERIOR END, BUT DOES NOT CONTACT THE INFERIOR VENA CAVA (IVC) WALL. ALL THE STRUTS OF THE IVC FILTER PERFORATE THE IVC UP TO 7MM. ONE ANTERIOR STRUT PERFORATES THE IVC WALL 5MM AND CONTACTS THE BOWEL. TWO MEDIAL STRUTS PERFORATE THE IVC WALL 5MM AND 6MM AND CONTACTS THE AORTA. ONE POSTERIOR STRUT PERFORATES THE IVC WALL 7MM AND RESIDES WITHIN THE SOFT TISSUES. TWO LATERAL STRUTS PERFORATE THE IVC WALL AT 5MM AND RESIDE WITHIN THE SOFT TISSUE. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.

  Patient problems: Internal Organ Perforation; Myocardial Infarction; Perforation of Vessels

  MAUDE report 15440681 ↗
• InjurySep 6, 2022Fracture; Unintended Movement; Fracture; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO SPECIFIC EVIDENCE THAT THE FILTER PERFORATES THE MESENTERY BY 4MM, IS TILTED WITH THE APEX AGAINST THE INFERIOR VENA CAVA (IVC) WALL AND HAS A FRACTURED STRUT. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.

  Patient problems: Internal Organ Perforation; Perforation of Vessels

  MAUDE report 15365264 ↗
• InjuryAug 31, 2022Therapeutic or Diagnostic Output Failure

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO FILTER PERFORATION. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.

  Patient problems: Perforation; Perforation of Vessels

  MAUDE report 15328912 ↗
• InjuryAug 30, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO MEDIAL AND POSTERIOR TILT OF THE FILTER AT THE SUPERIOR END; ANTERIOR TILT AT THE INFERIOR END WHERE IT CONTACTS THE INFERIOR VENA CAVA (IVC) WALL; PERFORATION OF THE IVC BY ALL STRUTS UP TO 6 MM WITH TWO ANTERIOR STRUTS PERFORATING THE IVC AT 4 MM AND 5 MM AND CONTACTS THE BOWEL. ONE MEDAL STRUT PERFORATES THE IVC WALL 4 MM AND RESIDES WITHIN THE SOFT TISSUES; ONE POSTERIOR STRUT PERFORATES THE IVC WALL AND CONTACTS THE LC VERTEBRAL BODY; AND TWO LATERAL STRUTS PERFORATE THE IVC WALL BOTH AT 4 MM AND RESIDE WITHIN THE SOFT TISSUES. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.

  Patient problems: Internal Organ Perforation; Perforation of Vessels

  MAUDE report 15324500 ↗
• InjuryAug 29, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO FILTER PERFORATION AND TILT. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.

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

  MAUDE report 15315574 ↗
• InjuryAug 29, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO FILTER PERFORATION AND TILT. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.

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

  MAUDE report 15314865 ↗
• InjuryAug 5, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, A PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO TILTING OF THE INFERIOR VENA CAVA (IVC) FILTER. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, AND PAIN AND SUFFERING AND OTHER DAMAGES.

  Patient problems: Failure of Implant

  MAUDE report 15174962 ↗
• InjuryAug 2, 2022Therapeutic or Diagnostic Output Failure

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO PERFORATION AND STENOSIS. THE PATIENT BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY TEN MONTHS AFTER THE INDEX PROCEDURE.

  Patient problems: Perforation; Perforation of Vessels; Stenosis

  MAUDE report 15147801 ↗
• InjuryJul 5, 2022Therapeutic or Diagnostic Output Failure

  AS REPORTED BY THE LEGAL BRIEF, A PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO FILTER PERFORATION. AS A DIRECT AND PROXIMATE RESULT, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.

  Patient problems: Perforation; Perforation of Vessels

  MAUDE report 14918845 ↗
• DeathJun 28, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO THE SUPERIOR END OF THE CORDIS FILTER WAS IN THE L2-L3 INTERSPACE; THE FILTER WAS TILTED LATERALLY AT THE SUPERIOR END AND THE HOOK CONTACTED THE INFERIOR VENA CAVA (IVC) WALL. ALL THE STRUTS OF THE IVC FILTER PERFORATED THE IVC UP TO 6MM. TWO (2) LATERAL STRUTS PERFORATED THE IVC AND CONTACTED THE AORTA. THE NATIVE LUMEN OF THE IVC WAS 10MM. DECEDENT UNDERWENT AN ANGIOPLASTY AND STENT PLACEMENT DILATION OF THE IVC PROCEDURE PERFORMED AND WITHIN THE CENTRAL PORTION OF THE IVC FILTER APPROXIMATELY FIVE YEARS AND TEN MONTHS AFTER THE INDEX PROCEDURE. THE LUMEN OF THE STENT WITHIN THE IVC FILTER DID NOT APPEAR TO BE PATENT. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE DECEDENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. THE PATIENT IS DECEASED, BUT THERE WAS NO INFORMATION PROVIDED TO RELATE THEIR DEMISE TO THE DEVICE. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUF

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Perforation of Vessels; Stenosis

  MAUDE report 14844572 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL DEPARTMENT, THE PATIENT UNDERWENT PLACEMENT OF THE TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, PERFORATION OF THE INFERIOR VENA CAVA (IVC).

  Patient problems: Perforation; Perforation of Vessels

  MAUDE report 14787197 ↗
• InjuryJun 9, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL DEPARTMENT, THE PATIENT UNDERWENT PLACEMENT OF THE TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, FILTER PERFORATION, TILT, AND STENOSIS. AS A DIRECT AND PROXIMATE RESULT, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.

  Patient problems: Perforation; Perforation of Vessels; Stenosis

  MAUDE report 14647140 ↗
• InjuryJun 8, 2022Fracture; Unintended Movement; Fracture; Unintended Movement

  AS REPORTED BY THE LEGAL DEPARTMENT, THE PATIENT UNDERWENT PLACEMENT OF THE TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, FILTER FRACTURE, PERFORATION, AND TILT. AS A DIRECT AND PROXIMATE RESULT, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.

  Patient problems: Perforation; Perforation of Vessels

  MAUDE report 14632789 ↗
• InjuryJun 6, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO ORGAN PERFORATION, TILT AND STENOSIS. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.

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

  MAUDE report 14601976 ↗
• InjuryJun 3, 2022Fracture; Fracture

  AS REPORTED IN THE LEGAL BRIEF, A PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING BUT NOT LIMITED TO FILTER FRACTURE AND ORGAN PERFORATION. AS A DIRECT AND PROXIMATE RESULT, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING AND OTHER DAMAGES.

  Patient problems: Internal Organ Perforation; Perforation of Vessels

  MAUDE report 14595883 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL DEPARTMENT, THE PATIENT UNDERWENT PLACEMENT OF THE TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, MALFUNCTION INCLUDING PERFORATION ABUTTING ADJACENT ORGANS . AS A DIRECT AND PROXIMATE RESULT, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.

  Patient problems: Perforation; Perforation of Vessels

  MAUDE report 14453460 ↗
• InjuryMay 17, 2022Unintended Movement; Unintended Movement

  AS REPORTED IN THE LEGAL BRIEF, A PATIENT WAS NOTED TO HAVE A CORDIS FILTER PER SCAN IMAGING DONE. THE TYPE OF FILTER WAS NOT IDENTIFIED. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, THE PATIENT IS AT RISK OF SUFFERING INJURIES, POSSIBLY PERMANENT AND LIFE-THREATENING, AND WILL REQUIRE EXTENSIVE MEDICAL CARE, MONITORING AND TREATMENT DUE TO LONG TERM IMPLANT OF THE IVC FILTER. THE PATIENT SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, LOSS OF ENJOYMENT OF LIFE, DISABILITY AND OTHER LOSSES, NOT LIMITED TO THE APPREHENSION AND RISK ASSOCIATED WITH RETAINING A DEFECTIVE DEVICE INSIDE THE BODY. THE REFERENCED FILTER WAS IDENTIFIED AS A TRAPEASE VENA CAVA FILTER. ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) STATES THAT THE PATIENT EXPERIENCED FILTER PERFORATION, TILT, FILTER EMBEDDED IN WALL OF THE INFERIOR VENA CAVA (IVC), BLOOD CLOTS, CLOTTING (BOTH LEGS AND GROIN), AND/OR OCCLUSION OF THE INFERIOR VENA CAVA (IVC). THE PATIENT BECAME AWARE OF BLOOD CLOTS IN BOTH LEGS AND GROIN STARTING THREE DAYS AFTER THE FILTER WAS IMPLANTED. THE PATIENT SOUGHT TREATMENT

  Patient problems: Coagulation Disorder; Device Embedded In Tissue or Plaque; Obstruction/Occlusion; Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 14420327 ↗
• InjuryMay 2, 2022Fracture; Migration; Fracture; Migration

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO MIGRATION, PERFORATION AND BROKEN POSTERIOR SIDE STRUT. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, AND PAIN AND SUFFERING, LOSS OF ENJOYMENT OF LIFE AND OTHER DAMAGES. INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF BILATERAL ACUTE PULMONARY EMBOLISM WITH RELATIVE CONTRAINDICATION OF ANTICOAGULATION. THE PATIENT WAS A POOR CANDIDATE FOR LONG TERM ANTICOAGULATION AS SHE STUMBLES AND HAS AN ATAXIC GAIT. THE FILTER WAS IMPLANTED VIA THE PATIENT'S RIGHT FEMORAL VEIN. THE TIP OF THE SHEATH WAS PLACED AT THE LEVEL OF THE FOURTH LUMBAR VERTEBRA. A VENA CAVA GRAM WAS PERFORMED. NO CLOTS WERE FOUND AND THE VENA CAVA MEASURED LESS THAN 30 MM IN DIAMETER. THE SHEATH WAS REPOSITIONED SO THAT TH

  Patient problems: Perforation of Vessels

  MAUDE report 14260916 ↗
• DeathApr 26, 2022Therapeutic or Diagnostic Output Failure

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO PERFORATION OF THE FILTER. THE PATIENT IS DECEASED, BUT THERE WAS NO INFORMATION PROVIDED TO RELATE HIS DEMISE TO THE DEVICE. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED SIGNIFICANT MEDICAL EXPENSES PAIN AND SUFFERING, LOSS OF ENJOYMENT OF LIFE AND OTHER DAMAGES. INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF PULMONARY EMBOLI. THE FILTER WAS IMPLANTED VIA THE PATIENT'S RIGHT FEMORAL VEIN USING THE SELDINGER TECHNIQUE. CONTRAST WAS INJECTED TO CONFIRM THERE WERE NO CLOTS WITHIN THE FEMORAL OR ILIAC VEINS. A VENOCAVOGRAM WAS PERFORMED. THIS DEMONSTRATED THE ORIGIN OF THE RENAL VEINS AND THE CAVAL DIAMETER (3 CM). THE FILTER WAS PLACED INTO THE INFRARENAL AREA OF THE INFERIOR VENA CAVA (IVC) WITH THE LEADING EDGE OF THE FILTER AT THE L2 LEVEL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Perforation of Vessels

  MAUDE report 14215257 ↗
• DeathApr 22, 2022Fracture; Migration; Fracture; Migration

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO MIGRATION, FRACTURE OF THE FILTER AND PERFORATION BY THE FILTER. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES. THE PATIENT IS DECEASED, BUT THERE WAS NO INFORMATION PROVIDED TO RELATE THEIR DEMISE TO THE DEVICE. ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF RECURRENT VENOUS THROMBOEMBOLIC DISEASE DESPITE USE OF COUMADIN AND MILD ALLERGIC REACTION TO CONTRAST IN THE DISTANT PAST. THE INDICATION FOR FILTER PLACEMENT WAS CHRONIC RECURRENT PULMONARY EMBOLISM (PE) DESPITE ADEQUATE ANTICOAGULATION OR CONTRAINDICATION TO ANTICOAGULATION. THE FILTER WAS IMPLANTED VIA THE PATIENT'S RIGHT FEMORAL VEIN USING REAL-TIME SONOGRAPHIC GUIDANCE. THE P

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Perforation of Vessels

  MAUDE report 14180477 ↗
• InjuryApr 20, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO TILT AND PERFORATION BY THE INFERIOR VENA CAVA (IVC) FILTER. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES. THE FILTER WAS IMPLANTED VIA THE PATIENT'S RIGHT FEMORAL VEIN. GUIDE WIRE WAS INSERTED AND THEN THE INTRODUCER WITH THE SHEATH WAS PASSED OVER THE GUIDE WIRE. THE INTRODUCER SHEATH WAS THEN POSITIONED BETWEEN L3-L4 LEVEL. NEXT, AN INFERIOR VENOCAVOGRAM WAS PERFORMED WHICH SHOWED A SINGLE INFERIOR VENA CAVA (IVC). THE INTRODUCER WAS REMOVED. THE FILTER WAS PASSED THROUGH THE SHEATH AND PUSHED BY THE OBTURATOR AND FIRED AT THE L3-L4 LEVEL, UPPER PART OF L3 LEVEL. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS IN STABLE CONDITION. INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (P

  Patient problems: Perforation of Vessels

  MAUDE report 14163565 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO PERFORATION BY THE INFERIOR VENA CAVA (IVC) FILTER. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES. ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF CHRONIC PULMONARY EMBOLISM (PE). THE FILTER WAS IMPLANTED VIA THE PATIENT'S RIGHT SIDE FEMORAL ACCESS. DOPPLER WAS USED TO FIND THE VEIN. A NEEDLE WAS PASSED INTO THE VEIN. FLUOROSCOPIC GUIDANCE WAS USED TO PASS THE GUIDE WIRE THROUGH THE NEEDLE WELL UP INTO THE IVC. NEXT AN INFERIOR VENOCAVOGRAM WAS TAKEN. THE PATIENT HAD A VERY FAST RUNOFF. IT TOOK SEVERAL RUNS TO DEFINE THE ANATOMY AND MAKE SURE THERE WERE NO CLOTS IN THE CAVA. NO CLOTS WERE SEEN. THE FILTER WAS PASSED UP TO THE END OF THE

  Patient problems: Perforation of Vessels

  MAUDE report 14162019 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO PERFORATION BY THE INFERIOR VENA CAVA (IVC) FILTER. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES. ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF MODERATE VENOUS INSUFFICIENCY, SUPERFICIAL THROMBOPHLEBITIS AND MORBID OBESITY. THE FILTER WAS IMPLANTED PRIOR TO PLANNED BARIATRIC SURGICAL PROCEDURE. THE FILTER WAS IMPLANTED VIA THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN (IJV). ULTRASOUND WAS USED TO CANNULATE THE RIGHT IJV. A GUIDE WIRE WAS PASSED THROUGH THE IJV THROUGH THE RIGHT ATRIUM AND VENTRICLE INTO THE INTERNAL VENA CAVA (IVC). THE FILTER WAS PLACED THROUGH THE DILATOR SHEATH TO THE L3 LEVEL. THE DILATOR SHEATH WAS WITHDRAWN. HEMOST

  Patient problems: Perforation of Vessels

  MAUDE report 14160613 ↗
• InjuryApr 8, 2022Fracture; Fracture

  AS REPORTED BY THE LEGAL TEAM, THE PATIENT UNDERWENT PLACEMENT OF THE TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, FRACTURED STRUT, PERFORATION, AND TENTING WITH THE IVC FILTER. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICATE MEDICAL EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES.

  Patient problems: Perforation; Perforation of Vessels

  MAUDE report 14054637 ↗
• InjuryApr 4, 2022Fracture; Unintended Movement; Fracture; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO FILTER FRACTURE, ORGAN PERFORATION AND TILT. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.

  Patient problems: Internal Organ Perforation; Perforation of Vessels

  MAUDE report 14006151 ↗