OptEase Vena Cava Filter 466F220ARecalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 20705032009413), received between Aug 8, 2017 and Sep 28, 2022 — classified as 3 deaths, 97 injuries.

The most frequently reported specific device problem is “Unintended Movement” (45 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 100 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2022Patient Device Interaction Problem

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE 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. 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 15499263 ↗
• InjurySep 20, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A OPTEASE 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 OF CHRONIC OCCLUSION OF THE INFERIOR VENA CAVA (IVC) AND BOTH COMMON EXTERNAL ILIAC VEINS, COLLAPSE OF THE IVC AND THROMBOSIS (CHRONIC IVC AND ILIAC). 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 STATE THAT THE PATIENT'S PREOPERATIVE DIAGNOSIS WAS MOTOR VEHICLE ACCIDENT (MVA), SPINAL INJURY, PARAPLEGIC, RESPIRATORY FAILURE, ENDOTRACHEAL TUBE, ENTERIC FEEDING TUBE, NASOGASTRIC TUBE AND SOME HAZY BILATERAL OPACITIES THAT WERE COMPATIBLE WITH UNDERLYING PULMONARY CONTUSIONS WERE SEEN ON A COMPUTED TOMOGRAPHY (CT) SCAN. THE FILTER WAS IMPLANTED VIA THE PATIENT'S RIGHT COMMON FEMORAL VEIN. THE FILTER WAS DEPLOYED INTO

  Patient problems: Coagulation Disorder; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 15459046 ↗
• InjurySep 16, 2022Positioning Problem

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A OPTEASE 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 INFERIOR VENA CAVA (IVC) WALL. 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 MEDICAL RECORDS STATE THAT THE PATIENT COMPLAINED OF BACK PAIN IMMEDIATELY PRIOR TO FILTER IMPLANTATION. THE FILTER WAS IMPLANTED VIA THE PATIENT'S RIGHT COMMON FEMORAL VEIN USING ULTRASOUND GUIDANCE. THE FILTER WAS DEPLOYED WITHIN THE INFRARENAL AREA. THE TIP OF THE FILTER WAS PLACED AT THE LEVEL OF THE LOWEST RENAL VEIN INFLOW. THE PATIENT TOLERATED THE PROCEDURE WITH WITHOUT ANY IMMEDIATE COMPLICATIONS. THE RESULTS OF COMPUTED TOMOGRAPHY (CT) SCAN DONE APPROXIMATELY SEVEN YEARS AND NINE MONTHS AFTER THE INDEX PROCEDURE INDICATE THAT THE FILTER WAS BELOW THE

  Patient problems: Perforation of Vessels

  MAUDE report 15442773 ↗
• InjurySep 16, 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 SPECIFIC EVIDENCE THAT THE FILTER BROKE, BECAME FRAGMENTED AND MIGRATED TO THE RIGHT GROIN. THIS REQUIRED FLUOROSCOPICALLY ASSISTED SURGERY WITH 3-4 INCH INCISIONS TO REMOVE THE FOREIGN BODY FROM THE PATIENT'S RIGHT UPPER THIGH. 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 MORBID OBESITY WITH INCREASED PROPENSITY FOR DEEP VEIN THROMBOSIS AND PULMONARY EMBOLI. THE FILTER WAS PLACED PROPHYLACTICALLY FOR GASTRIC BYPASS PROCEDURE. THE FILTER WAS IMPLANTED VIA THE PATIENT'S RIGHT COMMON FEMORAL VEIN. THE FILTER WAS DEPLOYED USING DIRECT FLUOROSCOPIC GUIDANCE. THERE WAS NO EVIDENCE OF MIGRATION

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

  MAUDE report 15435425 ↗
• InjurySep 14, 2022Failure to Align; Unintended Movement; Failure to Align; Unintended Movement

  AS REPORTED BY THE LEGAL DEPARTMENT, THE PATIENT UNDERWENT PLACEMENT OF THE OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, TILT AND EMBEDMENT OF THE FILTER. 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: Coagulation Disorder; Device Embedded In Tissue or Plaque; Obstruction/Occlusion

  MAUDE report 15415524 ↗
• InjurySep 9, 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 OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, THROMBOSED FILTER REQUIRING SUCTION THROMBECTOMY OF THE IVC AND COMPLEX FORCEPS RETRIEVAL OF THE FILTER. 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: Coagulation Disorder; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 15391566 ↗
• InjuryAug 31, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A OPTEASE 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: Perforation; Perforation of Vessels

  MAUDE report 15329379 ↗
• InjuryAug 31, 2022Failure to Align; Unintended Movement; Failure to Align; Therapeutic or Diagnostic Output Failure; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AV OPTEASE 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 15327368 ↗
• InjuryAug 23, 2022Material Perforation

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A OPTEASE 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 15279635 ↗
• InjuryAug 23, 2022Fracture; Fracture

  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 AND 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 15279312 ↗
• InjuryAug 18, 2022Fracture; Unintended Movement; Fracture; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO FRACTURED STRUT, PERFORATION AND 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: Perforation; Perforation of Vessels

  MAUDE report 15249922 ↗
• InjuryAug 11, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A OPTEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO UNSUCCESSFUL REMOVAL ATTEMPT DUE TO FILTER EMBEDMENT APPROXIMATELY FOURTEEN YEARS AND ELEVEN MONTHS AFTER THE INDEX PROCEDURE. THE PATIENT ALSO REPORTED PERFORATION APPROXIMATELY FIFTEEN YEARS AND NINE MONTHS AFTER THE INDEX PROCEDURE. ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF RIGHT KNEE REPLACEMENT, RIGHT KNEE SURGERY, BACK SURGERY, OBSTRUCTIVE SLEEP APNEA AND GASTROESOPHAGEAL REFLUX DISEASE. NINE DAYS BEFORE FILTER IMPLANT THE PATIENT UNDERWENT ARTHROSCOPIC KNEE SURGERY. THREE DAYS BEFORE THE PATIENT PRESENTED WITH INCREASED PAIN AND SWELLING AND WAS NOTED TO HAVE HEMARTHROSIS, REQUIRING TWO SUBSEQUENT SURGERIES FOR IRRIGATION, DEBRIDEMENT, LAVAGE AND DRAINAGE. THE PATIENT WAS ALSO NOTED TO HAVE EXTENSIVE DEEP VEIN THROMBOSIS (DVT) OF THE RIGHT LEG. THE PATIENT WAS STARTED ON ANTICOAGULATION THERAPY; HOWEVER, DUE TO CONTINUED BLEEDING PROBLEMS IT WAS DECIDED TO PLACE AN INFERIOR VENA CAVA (IVC) FIL

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

  MAUDE report 15210797 ↗
• InjuryAug 1, 2022Nonstandard Device; Therapeutic or Diagnostic Output Failure

  AS REPORTED, PATIENT HAD AN OPTEASE FILTER PLACED IN THE VENA CAVA SEVERAL YEARS AGO AND PATIENT HAS BEEN ON BLOOD THINNERS EVER SINCE AND HAVING NOTHING BUT PROBLEMS EVER SINCE. THE PATIENT MENTIONED THAT THEY WERE AWARE THE FILTER HAS BEEN RECALLED TWICE AND THAT THEY CANNOT GET IT OUT UNLESS THEY DO OPEN-CHEST SURGERY, WHICH THE PATIENT DOES NOT WANT TO DO AND THAT THEY WERE HAVING "MORE AND MORE PROBLEMS AFTER GETTING THIS THING". PER THE IMPLANT RECORDS, THE FILTER WAS INDICATED FOR RECURRENT RIGHT LOWER EXTREMITY DEEP VENOUS THROMBOSIS (DVT) DESPITE ANTICOAGULATION. THE RIGHT COMMON FEMORAL VEIN WAS ACCESSED USING MICROPUNCTURE SELDINGER TECHNIQUE. AN INFERIOR VENACAVAGRAM REVEALED A NORMAL SIZE INFERIOR VENA CAVA (IVC) WITH SOLITARY BILATERAL RENAL VEINS. THE DEVICE WAS PLACED INTO THE INFRARENAL LOCATION WITHOUT DIFFICULTY. POST PROCEDURE INFERIOR VENACAVAGRAM DEMONSTRATED EXCELLENT POSITIONING. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO IMMEDIATE COMPLICATIONS. ACCORDING TO THE INFORMATION RECEIVED IN THE PATIENT PROFILE FORM (PPF), THE PATIENT REPORTS BLOOD CLOTS, CLOTTING AN OCCLUSION OF THE IVC, BECOMING AWARE OF THESE EVENTS APPROXIMATELY NINE YEARS AND

  Patient problems: Coagulation Disorder; Obstruction/Occlusion

  MAUDE report 15141675 ↗
• InjuryJul 12, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE 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 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Easy Bruising; Pain

  MAUDE report 14988398 ↗
• InjuryJul 12, 2022Fracture; Unintended Movement; Fracture; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE 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 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Unspecified Tissue Injury

  MAUDE report 14988222 ↗
• InjuryJul 5, 2022Fracture; Fracture

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN UNSPECIFIED VENA CAVA FILTER MANUFACTURED BY CORDIS. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO FILTER FRACTURE. 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 of Vessels; Unspecified Tissue Injury

  MAUDE report 14918810 ↗
• InjuryJun 28, 2022Fracture; Fracture

  AS REPORTED IN THE LEGAL BRIEF, A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO A FRACTURED STRUT. AS A DIRECT AND PROXIMATE RESULT OF THIS MALFUNCTION, 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: Pain; Unspecified Tissue Injury

  MAUDE report 14842708 ↗
• InjuryJun 24, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL DEPARTMENT, THE PATIENT UNDERWENT PLACEMENT OF THE OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY, DAMAGE, AND/OR WRONGFUL DEATH TO PLAINTIFF/DECEDENT, INCLUDING, BUT NOT LIMITED TO: TILT AND PERFORATION OF THE VENA CAVA.

  Patient problems: Perforation of Vessels

  MAUDE report 14798708 ↗
• InjuryJun 15, 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 OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, PERFORATION OF THE VENA CAVA AND ABUTMENT OF THE ILIAC ARTERY AND VEIN.

  Patient problems: Coagulation Disorder; Perforation of Vessels; Pulmonary Embolism

  MAUDE report 14700922 ↗
• InjuryJun 8, 2022Fracture; Unintended Movement; Fracture; Unintended Movement

  AS REPORTED BY THE LEGAL DEPARTMENT, THE PATIENT UNDERWENT PLACEMENT OF THE OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, FILTER FRACTURE, ORGAN 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 14635742 ↗
• InjuryJun 3, 2022Unintended Movement; Unintended Movement

  AS REPORTED IN THE LEGAL BRIEF, A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING BUT NOT LIMITED TO FILTER PERFORATION, TILTING 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 SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING AND OTHER DAMAGES.

  Patient problems: Perforation; Stenosis

  MAUDE report 14595383 ↗
• 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 OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, 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: Internal Organ Perforation; Perforation; Perforation of Vessels

  MAUDE report 14453466 ↗
• InjuryMay 11, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO SHORTNESS OF BREATH, CHEST PAIN, BACK PAIN, ABDOMINAL PAIN, AND INTERNAL DISCOMFORT. FURTHERMORE, PLAINTIFF HAS LEARNED THAT THE FILTER IS TILTED LATERALLY (11 DEGREES ) AND ANTERIORLY (16 DEGREES ), SUCH THAT THE CEPHALAD FILTER APEX IS IN DIRECT CONTACT WITH THE ANTERIOR CAVAL WALL AND THE CAUDAL APEX/HOOK IS IN DIRECT CONTACT WITH THE POSTERIOR CAVAL WALL. BOTH PORTIONS OF THE FILTER ARE LIKELY TO BE PARTIALLY EMBEDDED AT THESE POINTS OF PHYSICAL CONTACT. ALL SIX (6) OF THE FILTER'S PRIMARY STRUTS TENTS THE CAVAL WALL WITH EARLY PERFORATION AND DIRECT IMPINGEMENT ON OVERLYING SMALL BOWEL (DUODENUM) VISIBLE ANTERIORLY. 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: Device Embedded In Tissue or Plaque; Perforation of Vessels

  MAUDE report 14350672 ↗
• InjuryApr 21, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE 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 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, PAIN AND SUFFERING, AND OTHER DAMAGES.

  Patient problems: Emotional Changes; Pain

  MAUDE report 14179474 ↗
• InjuryApr 4, 2022Unintended Movement; Migration; Unintended Movement; 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 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: Perforation; Perforation of Vessels

  MAUDE report 14006369 ↗