OptEase Vena Cava Filter 466F230AFRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 20705032072899), received between Oct 9, 2017 and May 16, 2022 — classified as 1 death, 14 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2022Defective Component

  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. 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 INFERIOR VENA CAVA (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. APPROXIMATELY FIVE MONTHS AFTER THE INDEX PROCEDURE AN ABDOMINAL COMPUTED TOMOGRAPHY (CT) SCAN WAS DONE TO EVALUATE THE INFERIOR VENA CAVA, UNSPECIFIED INJURY. THE IMAGES DEPICT A CORDIS TYPE IVC FILTER AND INCOMPLETELY VISUALIZED RIGHT COMMON AND EXTERNAL ILIAC VENOUS STENTS. THE IMAGES REVEALED: CHOLECYSTECTOMY CLIPS, SEVERAL SUBCUTANEOUS VENOUS COLLATERAL AND THE INFERIOR VENA CAVA (IVC) FILTER WAS NOTED. THERE WAS NO EVIDENCE TO SUGGEST IVC PERFORATION ON THE IMAGES. ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) STA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Coagulation Disorder; Obstruction/Occlusion; Pulmonary Embolism

  MAUDE report 14407634 ↗
• DeathApr 4, 2022Fracture; Fracture

  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 FRACTURE AND ORGAN 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 14005768 ↗
• InjuryMar 4, 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 AND PAIN. 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: Coagulation Disorder; Pain; Unspecified Tissue Injury

  MAUDE report 13669040 ↗
• InjuryAug 20, 2021Adverse Event Without Identified Device or Use 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 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. INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF DEEP VEIN THROMBOSIS (DVT) IN LEFT POPLITEAL, ABDOMINAL PAIN, ATYPICAL CHEST PAIN, DYSPNEA, MULTIPLE GASTROINTESTINAL BLEEDING, MULTIPLE BILATERAL PULMONARY EMBOLISMS, ANGIOECTASIAS OF ESOPHAGUS AND COLON, IRON DEFICIENCY ANEMIA, CHRONIC CRAMPS, HYPOTENSION AND SCLERODERMA WHICH INCLUDES TELANGIECTASIA. THE PATIENT WAS HOSPITALIZED TWO WEEKS PRIOR FOR ANEMIA. THE PATIENT PRESENTED AT THE HOSPITAL WITH SHARP RIGHT UPPER QUADRANT PAIN THAT RADIATED TO RIGHT SHOULDER AND BACK. IT WORSENED WITH BREATHING. SHE EXPERIENCED DIFFICULTY BREATHI

  Patient problems: Perforation of Vessels

  MAUDE report 12351182 ↗
• InjuryAug 2, 2021Unintended Movement; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF MORBID OBESITY AND HYPERCOAGULABLE STATE. THE INDICATION FOR THE FILTER PLACEMENT WAS PROPHYLAXIS PRIOR TO GASTRIC BYPASS SURGERY DUE TO A HIGH RISK FOR THROMBOEMBOLISM. THE FILTER WAS PLACED VIA THE RIGHT COMMON FEMORAL VEIN AND WAS DEPLOYED AT THE L2-L3 INTERVERTEBRAL DISK. APPROXIMATELY EIGHT MONTHS LATER A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN WAS PERFORMED, THE INDICATION FOR THE EXAM WAS NOT PROVIDED. RESULTS NOTED THE FILTER IS IN PLACE, A 3CM RIGHT ADNEXAL CYST, SMALL FAT CONTAINING VENTRAL HERNIA AND DIFFUSE SIGNIFICANT FATTY LIVER. ONE YEAR AND FOUR MONTHS LATER A DUPLEX ULTRASOUND OF THE LOWER EXTREMITIES WAS PERFORMED. HISTORY NOTED AT THE TIME OF THE EXAM WAS ELEVATED D-DIMER, ANEMIA AND ANXIETY. THE EXAM WAS NEGATIVE FOR DEEP VEIN THROMBOSIS. APPROXIMATELY THREE YEARS AND FIVE MONTHS POST IMPLANT AN ABDOMINAL CT SCAN WAS PERFORMED FOR ABDOMINAL PAIN. RESULTS OF THE SCAN NOTED THE FILTER IS TILTED AND ONE LEG OF THE FILTER QUESTIONABLY PROJECTS BEYOND THE IVC. THE FILTER APPEARS INTACT. THE LIVER WAS NOTED TO APPEAR NORMAL IN THIS SCAN. ADDITIONAL INFORMATION RECEI

  Patient problems: Perforation of Vessels

  MAUDE report 12264567 ↗
• MalfunctionMar 31, 2021Fracture; Fracture

  PRIOR TO A PLANNED RETRIEVAL OF A 55 FEMORAL OPTEASE RETRIEVABLE VENA CAVA FILTER AFTER 14 DAYS, ONE OF THE STRUTS WAS BROKEN BUT REMAINED ATTACHED TO THE FILTER. THERE WAS NO REPORTED PATIENT INJURY. THE FILTER WAS PLACED IN INFERIOR VENA CAVA (IVC) PROPERLY. THE INDICATION FOR FILTER PLACEMENT WAS DEEP VEIN THROMBOSIS (DVT). THROMBUS WAS PRESENT AT THE DELIVERY SITE. PRE AND POST IMAGING WERE COMPLETED BUT THE RESULTS WERE NOT PROVIDED. THERE WAS NO DIFFICULTY REMOVING THE FILTER AND NO EXCESSIVE FORCE WAS USED. THE STRUTS WERE NOT STUCK TO THE VESSEL AND NO EXCESSIVE FORCE USED TO RETRIEVE THE FILTER. ADDITIONAL PATIENT AND PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED BY THE PHYSICIAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11596103 ↗
• InjuryDec 30, 2020Fracture; Fracture

  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, MALFUNCTION, INCLUDING PERFORATION, FRACTURE AND PERFORATION ABUTTING ORGAN THAT CAUSES INJURY AND DAMAGE TO THE PLAINTIFF. 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. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED PER THE PATIENT¿S IMPLANT RECORDS: THE FILTER WAS IMPLANTED DUE TO THE PATIENT HAS SIGNIFICANT PULMONARY EMBOLISM AND DEEP VEIN THROMBOSIS AND IT WAS FELT PRUDENT TO INSERT AN IVC FILTER, TO PROTECT HIM FROM ANOTHER MASSIVE PULMONARY EMBOLUS WHICH COULD POTENTIALLY BE FATAL. CONCOMITANT DEVICES: COOK SHEATH. RELEVANT TESTS: VENOGRAM WAS PERFORMED (B)(6) 2016. ACCORDING TO THE INFORMATION RECEIVED IN THE PATIENT PROFILE FORM (PPF), PATIENT BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY 3YRS POST IMPLANTATI

  Patient problems: Perforation

  MAUDE report 11099126 ↗
• InjuryOct 16, 2020Adverse 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 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 OCCLUSION. INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF BILATERAL PULMONARY EMBOLIZATION (ESPECIALLY THE RIGHT PULMONARY ARTERY) AND LEFT DEEP VEIN THROMBOSIS (ACUTE THROMBUS FORMATION INVOLVING THE FEMORAL DOWN TO THE POPLITEAL VEIN, NONCOMPRESSIBLE, ABSENCE OF FLOW). THE FILTER WAS DEPLOYED VIA THE PATIENT'S RIGHT FEMORAL VEIN. IN ADDITION TO PLACEMENT OF THE FILTER, THE PATIENT HAD MULTIPLE PROCEDURES ON THE SAME DAY. THE PATIENT HAD A RIGHT HEART CATHETERIZATION AND PLACEMENT OF EKOS SYSTEM TO THE RIGHT PULMONARY ARTERY. POST-OPERATIVE DIAGNOSIS WAS MILD PULMONARY HYPERTENSION. INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) STATES THAT THE PATIENT EXPERIENCED ANXIETY, BLOOD CLOTS, CLOTTING AND/OR OCCLUSION OF THE INFERIOR VENA CAVA (IVC). THE PATIENT BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY FOUR YEARS AND THREE MONTHS AFTER THE INDEX PROCEDURE.

  Patient problems: Coagulation Disorder; Obstruction/Occlusion

  MAUDE report 10691321 ↗
• InjuryJul 17, 2020Difficult to Remove; Unintended Movement; Difficult to Remove; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES INCLUDING, BUT NOT LIMITED TO: PERFORATION AND OCCLUSION. INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF DEEP VENOUS THROMBOSIS, PULMONARY EMBOLUS (WHILE ON CHRONIC ANTICOAGULATION TREATMENT), MENINGITIS (TWO MONTHS PRIOR), BILATERAL MIXED HEARING LOSS AND POSSIBLE CHOLESTEATOMA OF MASTOID AND LEFT EAR VERSUS ENCEPHALOCELE. A FEW DAYS PRIOR TO SURGERY, HIS SPINAL HEADACHES WORSENED. A HEAD COMPUTED TOMOGRAPHY (CT) SCAN WAS DONE THE DAY PRIOR TO SURGERY AND DEMONSTRATED THIN BILATERAL SUBDURAL HYGROMAS. ON THE DAY OF THE FILTER PLACEMENT, THE PATIENT ALSO HAD THE FOLLOWING PROCEDURES: LEFT TEMPORAL CRANIOTOMY FOR APPROACH TO MIDDLE FOSSA, REPAIR OF MIDDLE FOSSA ENCEPHALOCELE (WITH A FAT GRAFT AND CRANIOS-BONE CEMENT), LEFT TYMPANOPLASTY AND MASTOIDECTOMY. THE FILTER WAS DEPLOYED VIA ULTRASOUND-GUIDED ACCESS THROUGH THE PATIENT'S RIGHT COMMON FEMORAL VEIN. THE FILTER WAS PLACED AT THE L2-L3 LEVEL.   INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) STATES THAT THE PATIENT EXPER

  Patient problems: Embolus; Occlusion; Perforation of Vessels

  MAUDE report 10289274 ↗
• InjuryJul 6, 2020Fracture; Failure to Align; Migration; Fracture; Failure to Align; Migration

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A OPTEASE VENA CAVA FILTER. THE PATIENT WAS HOSPITALIZED FOR HEAD TRAUMA AN HEMORRHAGE. APPROXIMATELY TWO WEEKS LATER AN OPTEASE VENA CAVA FILTER WAS PLACED INTO THE PATIENT'S SUPERIOR VENA CAVA. THE FILTER WAS PLACED IN A DIFFERENT ORIENTATION THAN HOW THE FILTER WOULD NORMALLY BE PLACED. IT WAS PLACED SUCH THAT THE RETRIEVAL HOOK WAS POINTING TOWARD THE PATIENT'S FEET AND THE FIXATION BARBS WERE POINTING TOWARD HIS HEAD. AS SUCH THE FIXATION BARBS WERE NOT CORRECTLY ORIENTED TO RESIST PRESSURE FROM BLOOD FLOW AND/OR BLOOD CLOTS WHEN PLACED IN THE SUPERIOR VENA CAVA. NO LATER THAN ONE WEEK AFTER THE INDEX PROCEDURE, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE DEVICE HAD MIGRATED TO THE PATIENT'S RIGHT VENTRICLE AND COULD BE SEEN IN THE PATIENT'S HEART. THE PATIENT WAS DISCHARGED TWELVE DAYS AFTER THE INDEX PROCEDURE. THREE DAYS AFTER BEING DISCHARGED, THE PATIENT WAS HOSPITALIZED AGAIN. HE UNDERWENT RADIOLOGICAL IMAGING PROCEDURES, WHICH REPEATEDLY DEMONSTRATED THAT THE FILTER HAD MIGRATED TO THE PATIENT'S HEART. THE PATIENT WAS DISCHARGED TWELVE DAYS AFTER ADMISSION WITH THE FILTER STILL LODGED IN HIS HEART.

  Patient problems: Atrial Fibrillation; Heart Failure; No Code Available; Thrombosis; Vessel Or Plaque, Device Embedded In

  MAUDE report 10233254 ↗
• InjuryJun 24, 2020Fracture; Unintended Movement; Fracture; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES INCLUDING, BUT NOT LIMITED TO: FRACTURE, PERFORATION, AND FILTER TILT. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED PER MEDICAL RECORDS: APPROXIMATELY 4-MONTHS PRIOR TO IVC FILTER IMPLANTATION, THE PATIENT UNDERWENT PLACEMENT OF PORT WITH CATHETER PLACED AT THE ATRIOCAVAL JUNCTION. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED PER IMPLANT RECORDS: THE PATIENT HAS HISTORY OF (B)(6) AND INVASIVE RECTAL ADENOCARCINOMA BEING TREATED WITH CHEMO. THE PATIENT WAS SCHEDULED FOR AN ABDOMINAL PERINEAL RESECTION (APR) APPROXIMATELY 10-DAYS POST IMPLANTATION. INDICATION FOR FILTER PLACEMENT WAS LIKELIHOOD OF BEDREST FOR SEVERAL DAYS FOLLOWING THE APR. ULTRASOUND WAS USED TO LOCATE THE COMMON FEMORAL VEIN. ACCESS WAS OBTAINED AND FLUOROSCOPY LOCATED THE RENAL VEINS AT L1 LEVEL. AN OPTEASE IVC FILTER WAS DEPLOYED SUCCESSFULLY JUST BELOW THE RENAL VEINS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT COMPLICATION AND THE PATIENT WAS TAKEN TO PACU PRIOR TO DISCHARGE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED PER PATIEN

  Patient problems: Perforation of Vessels

  MAUDE report 10189159 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(6) STUDY, APPROXIMATELY FOUR MONTHS POST OPTEASE RETRIEVABLE VENA CAVA FILTER IMPLANTATION, THE PATIENT WENT TO THE PRIMARY CARE PHYSICIAN AND WAS ADMITTED FOR PAIN AND SWELLING IN BILATERAL LEGS. AN ULTRASOUND WAS DONE AND A BILATERAL OCCLUSIVE AND NONOCCLUSIVE THROMBOSIS WAS REPORTED, HOWEVER, THE DEGREE OF OCCLUSION WAS NOT REPORTED. THE SUBJECT WAS DISCHARGED ON FOUR DAYS LATER WITH BILATERAL DEEP VEIN THROMBOSIS (DVT) ONGOING. THEN, APPROXIMATELY A MONTH LATER, THE PATIENT PRESENTED BACK TO THE HOSPITAL WITH THE SAME COMPLAINT. INTERVENTIONAL RADIOLOGY PROCEDURE WAS PERFORMED; HOWEVER, IT WAS INCOMPLETE DUE TO HIGH RISK OF BLEEDING FROM ANEURYSM. INTRAVENOUS HEPARIN THERAPY CONTINUED AND THE PATIENT WAS DOSED WITH COUMADIN. THE PATIENT WAS DISCHARGED TWO DAYS LATER. FIVE MONTHS AND FIVE DAYS POST DEVICE IMPLANTATION, THE PATIENT PRESENTED BACK TO THE HOSPITAL WITH BILATERAL DVT. BILATERAL LOWER EXTREMITIES VENOUS DOPPLER SHOWED OCCLUSIVE DVT. ORAL ANTI-COAGULATION THERAPY FAILED DUE TO NON-COMPLIANCE. THE PATIENT WAS DISCHARGED TWO DAYS LATER. THE EVENT WAS REPORTED AS ONGOING AT THE TIME OF DISCHARGED. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRU

  Patient problems: Occlusion

  MAUDE report 9872278 ↗
• InjuryFeb 25, 2020Difficult to Remove; Difficult to Remove

  AS REPORTED BY THE PRESERVE TRIAL DATA, OPTEASE RETRIEVABLE VENA CAVA FILTER WAS PLACED AS PROPHYLAXIS IN THE ABSENCE OF DEEP VEIN THROMBOSIS (DVT) OR PULMONARY EMBOLISM (PE). THE PATIENT WAS ADMITTED TO THE HOSPITAL, CONSENTED AND THE DEVICE WAS PLACED WITHOUT COMPLICATION. THE PATIENT WAS DISCHARGED FOURTEEN DAYS POST-IMPLANTATION. EIGHTEEN DAYS POST-IMPLANTATION, THE PATIENT PRESENTED FOR IVC FILTER RETRIEVAL. VENOGRAM DURING PROCEDURE IDENTIFIED THAT THERE WAS SIGNIFICANT NEAR OCCLUSIVE THROMBUS OF THE ENTIRE IVC FROM THE ILIAC BIFURCATION AND RADIATING UP TO THE APEX OF THE FILTER. OCCLUSION WAS APPROXIMATELY SEVENTY PERCENT (70%) WITH PARTIAL FLOW BEYOND THE FILTER. MANUAL ASPIRATION THROMBECTOMY OF THE FILTER WAS PERFORMED TO REMOVE A SIGNIFICANT AMOUNT OF THROMBUS AND TO IMPROVE THE FLOW CHANNEL. HOWEVER, FILTER RETRIEVAL COULD NOT BE PERFORMED DUE TO THE THROMBUS. THEREFORE, FORTY-NINE DAYS POST IMPLANTATION, THE PATIENT DECIDED TO WITHDRAW FROM THE STUDY SINCE THE PATIENT WAS IN AN EXTENDED CARE FACILITY AND THE FILTER RETRIEVAL WAS UNSUCCESSFUL AT WHICH TIME THE ACUTE THROMBUS WAS CONSIDERED ONGOING. THE PRINCIPAL INVESTIGATOR (PI) CONSIDERED THE EVENT EXPECTED AND POSSI

  Patient problems: Thrombosis

  MAUDE report 9752948 ↗
• InjuryJan 28, 2020Entrapment of Device; Fracture; Failure to Align; Migration; Failure to Align

  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, INFERIOR VENA CAVA (IVC) PERFORATION, FILTER MIGRATION, TILTING OF THE FILTER, AND EMBEDMENT. 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. ADDITIONAL INFORMATION WAS PROVIDED, AND PER THE IMPLANT RECORDS, THE FILTER WAS INDICATED FOR BILATERAL PULMONARY EMBOLI (PE) AND DEEP VEIN THROMBOSIS (DVT). AN OPTEASE INFERIOR VENA CAVA FILTER WAS INITIALLY DEPLOYED BELOW THE RENAL VEINS; HOWEVER, THE FILTER MOVED DOWNWARDS DURING PLACEMENT (B)(4)). THE FILTER WAS THEREFORE SUCCESSFULLY RETRIEVED WITHOUT ANY OTHER REPORTED COMPLICATIONS, AND ANOTHER (NEW) OPTEASE FILTER (B)(4)) WAS THEN DEPLOYED BELOW THE RENAL VEINS WITHOUT ANY DIFFICULTY. THE PATIENT TOLERATED THE PROCEDURE WELL. ACCORDING TO THE INFORMATION RECEIVED IN THE PATIENT PROFILE FORM (PPF),

  Patient problems: Anxiety; Chest Pain; Dyspnea; Failure of Implant; Fatigue; Perforation; Perforation of Vessels; Vessel Or Plaque, Device Embedded In

  MAUDE report 9636861 ↗
• MalfunctionMar 29, 2019Difficult to Insert; Material Puncture/Hole; Difficult to Insert; Material Puncture/Hole

  IT WAS REPORTED THAT AN OPTEASE (FEMORAL 55CM KIT) WAS ADVANCED WITH AN OBTURATOR AFTER THE FILTER WAS INSERTED INTO A NON-CORDIS 4F SHEATH; HOWEVER, THERE WAS STRONG RESISTANCE FELT AND IT WAS REMOVED FROM THE PATIENT. THE PHYSICIAN CONFIRMED THAT PART OF THE FILTER WAS EXPOSED FROM THE SHEATH. THE PRODUCT EVALUATION INDICATED THAT PER VISUAL ANALYSIS, THE CANNULA SHEATH PRESENTED A PUNCTURE CONDITION AT 4.5 CM FROM THE DISTAL END AND ONE FILTER BARB WAS OBSERVED PROTRUDING THE CANNULA SHEATH WALL AT 4.5 CM FROM THE DISTAL END. THIS WAS A DEEP VEIN THROMBOSIS CASE. THE SHEATH WAS INSERTED FROM THE RIGHT FEMORAL VEIN. THERE WAS NO SEVERE TORTUOSITY. THE DEVICE WAS USED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO REPORTED PATIENT INJURY. THE OBTURATOR REMAINED FIXED WHILE THE DEPLOYMENT SHEATH WAS PULLED BACK OVER THE OBTURATOR. IT WAS VERIFIED UNDER FLUOROSCOPY THAT THE FILTER WAS NOT IN A SIDE VESSEL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464225 ↗
• InjuryNov 29, 2018Difficult to Remove; Unintended Movement; Difficult to Remove; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY, LIMITED TO: INABILITY TO RETRIEVE THE DEVICE DUE TO THE FILTER BEING EMBEDDED. ACCORDING TO THE INFORMATION RECEIVED IN THE PATIENT PROFILE FROM (PPF), AN OPTEASE INFERIOR VENA CAVA (IVC) FILTER WAS IMPLANTED AND THE INFORMATION PROVIDED INDICATED THAT THE FILTER HAS MIGRATED TO THE HEART, IS EMBEDDED AND CANNOT BE RETRIEVED. THE PATIENT BECAME AWARE OF THE ALLEGED FAILURES APPROXIMATELY FIVE MONTHS POST IMPLANT. AN UNSUCCESSFUL RETRIEVAL ATTEMPT WAS MADE APPROXIMATELY FIVE MONTHS POST IMPLANT. THE PATIENT IS ALSO REPORTED TO HAVE EXPERIENCED MENTAL ANGUISH AND ANXIETY REGARDING THE STATUS OF THE FILTER. THE FOLLOWING ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT, THE FILTER WAS PLACED VIA THE RIGHT GROIN. APPROXIMATELY FIVE MONTHS LATER AN UNSUCCESSFUL RETRIEVAL ATTEMPT WAS MADE. A VENOGRAM PERFORMED DURING THE PROCEDURE SHOWED A WIDELY PATENT IVC AND PATENT IVC FILTER. A FILLING DEFECT WAS NOTED ON THE RIGHT LATERAL ASPECT OF THE VENA CAVA WALL, POSSIBLY DUE TO MIGRATION OF THE FILTER THROUGH THE VENA CAVA OR JUST A FILLING DEFECT ALONG THE LATERAL ASPECT OF THE VENA C

  Patient problems: Anxiety

  MAUDE report 8117689 ↗
• InjuryMar 29, 2018Difficult to Remove; Failure to Align; Migration; Difficult to Remove; Failure to Align; Migration

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF DEFENDANTS¿ OPTEASE FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, FAILED REMOVAL OF 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, AND PAIN AND SUFFERING, AND OTHER DAMAGES.

  Patient problems: No Known Impact Or Consequence To Patient; Perforation of Vessels

  MAUDE report 7382679 ↗
• MalfunctionOct 9, 2017Partial Blockage; Difficult to Insert; Partial Blockage; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED FROM FAL AND THE SHEATHS WERE RECEIVED WITH THE FILTER BARB WAS PROTRUDING FROM CANNULA SHEATH. UPON DEPLOYMENT, TWO OPTEASE FILTERS WERE STUCK IN THEIR RESPECTIVE SHEATH INTRODUCERS. ANOTHER OPTEASE FILTER WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. BOTH FILTERS WERE USED IN THE SAME PATIENT. THE INTENDED LESION IS THE VENA CAVA. IT IS NOT CLEAR IF THE SHEATH KINKED. "THE PATIENT WAS THICK." THE PRODUCTS WERE INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL. THE PRODUCTS WERE PREPPED PROPERLY ACCORDING TO THE INSTRUCTION FOR USE (IFU). THERE WERE NO DIFFICULTY REPORTED FLUSHING THE CATHETERS PRIOR TO USE. BOTH THE OPTEASE FILTER AND THE SHEATH INTRODUCER WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6931225 ↗
• MalfunctionOct 9, 2017Partial Blockage; Difficult to Insert; Partial Blockage; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED FROM FAL AND THE SHEATHS WERE RECEIVED WITH THE FILTER BARB WAS PROTRUDING FROM CANNULA SHEATH. UPON DEPLOYMENT, TWO OPTEASE FILTERS WERE STUCK IN THEIR RESPECTIVE SHEATH INTRODUCERS. ANOTHER OPTEASE FILTER WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. BOTH FILTERS WERE USED IN THE SAME PATIENT. THE INTENDED LESION IS THE VENA CAVA. IT IS NOT CLEAR IF THE SHEATH KINKED. "THE PATIENT WAS THICK." THE PRODUCTS WERE INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL. THE PRODUCTS WERE PREPPED PROPERLY ACCORDING TO THE INSTRUCTION FOR USE (IFU). THERE WERE NO DIFFICULTY REPORTED FLUSHING THE CATHETERS PRIOR TO USE. BOTH THE OPTEASE FILTER AND THE SHEATH INTRODUCER WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6930983 ↗