VENA TECH 5010024Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 04038653918164), received between Feb 9, 2016 and May 29, 2026 — classified as 7 deaths, 27 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Improper or Incorrect Procedure or Method

  AS REPORTED BY THE USER FACILITY: FILTER DID NOT FULLY DEPLOY AT THE TIME OF IMPLANT AND HAS SINCE "OPENED" UP MORE TO ABOUT 50% THEY CAN'T RETURN IT, IT'S STILL IN THE PATIENT. THE PATIENT IS MOST LIKELY GOING TO A DIFFERENT HOSPITAL TO HAVE IT REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331029 ↗
• MalfunctionMay 20, 2026Activation Failure

  AS REPORTED BY THE USER FACILITY: FILTER DID NOT FULLY DEPLOY AT THE TIME OF IMPLANT AND HAS SINCE "OPENED" UP MORE TO ABOUT 50% THEY CAN'T RETURN IT, IT'S STILL IN THE PATIENT. THE PATIENT IS MOST LIKELY GOING TO A DIFFERENT HOSPITAL TO HAVE IT REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233105 ↗
• InjuryJun 17, 2024Activation Failure; Activation Failure

  IVC FITTER WAS INSERTED VIA RT. JUGULAR ACCESS. ONCE DEPLOUED STRUTS DID NOT OPEN. HAD TO MANIPULATE WIRES/ CATHETERS TO OPEN FITTERS STRUTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554500 ↗
• InjuryJun 6, 2024Activation Failure; Activation Failure

  THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). AS REPORTED BY THE USER FACILITY: IVC FITTER WAS INSERTED VIA RT. JUGULAR ACCESS. ONCE DEPLOYED STRUTS DID NOT OPEN. HAD TO MANIPULATE WIRES/ CATHETERS TO OPEN FITTERS STRUTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476860 ↗
• InjuryOct 29, 2022Material Fragmentation; Material Fragmentation

  VENATECH LP FILTER IMPLANTED INTO PATIENT ON OR ABOUT (B)(6), 2011 AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS ('DVT) AND PULMONARY EMBOLUI ('PE'). ON OR ABOUT (B)(6), 2022 PATIENT UNDERWENT DIAGNOSTIC IMAGING. EXAMINATION OF THE IMAGING BY A QUALIFIED EXPERT RADIOLOGIST SHOWED MULTIPLE STRUTS FRACTURED IN THE VICINITY OF THE LOWER THORACIC SPINE. PATIENT IS AT RISK FOR FUTURE MIGRATIONS, FRACTURES AND PERFORATIONS FROM THE RETAINED VENATECH LP FILTER, AND FACES NUMEROUS HEALTH RISKS, INCLUDING THE RISK OF DEATH. PATIENT WILL REQUIRE ONGOING MEDICAL CARE AND MONITORING FOR THE REST OF HIS LIFE. IT SHOULD BE NOTED THE ACTUAL PRODUCT CODE WAS NOT LISTED IN THE DOCUMENT AND A BATCH NUMBER WAS NOT PROVIDED TO ASSIST IN VERIFY THE ACTUAL PRODUCT CODE. THE PRODUCT CODE USED IS THE CODE FOR THE VENA TECH LP FILTER AS LISTED IN THE DOCUMENT.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 15694848 ↗
• InjuryOct 28, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  VENATECH LP FILTER IMPLANTED INTO PATIENT ON OR ABOUT (B)(6) 2004 AFTER BEING DIAGNOSED WITH DVT AND PE. ON OR ABOUT (B)(6) 2021 PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN OF HIS ABDOMEN. EXAMINATION BY A QUALIFIED EXPERT RADIOLOGIST SHOWED MULTIPLE STRUTS PERFORATIONS THROUGH WALL OF HIS INFERIOR VENA CAVA WITH ONE STRUT ABUTTING THE DUODENUM, IT ALSO SHOWED A STRUT IN CONTACT WITH A VERTEBRAL BODY CAUSING A BONY REACTION. PATIENT IS AT RISK FOR FUTURE MIGRATIONS, FRACTURES AND PERFORATIONS FROM THE RETAINED VENATECH LP FILTER, AND FACES NUMEROUS HEALTH RISKS, INCLUDING THE RISK OF DEATH. PATIENT WILL REQUIRE ONGOING MEDICAL CARE AND MONITORING FOR THE REST OF HIS LIFE. IT SHOULD BE NOTED THE ACTUAL PRODUCT CODE WAS NOT LISTED IN THE DOCUMENT AND A BATCH NUMBER WAS NOT PROVIDED TO ASSIST IN VERIFY THE ACTUAL PRODUCT CODE. THE PRODUCT CODE USED IS THE CODE FOR THE VENA TECH LP FILTER AS LISTED IN THE DOCUMENT.

  Patient problems: Bowel Perforation; Great Vessel Perforation; Spinal Column Injury

  MAUDE report 15692028 ↗
• InjuryOct 11, 2022Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). AS REPORTED BY THE USER FACILITY: VENATECH LP FILTER IMPLANTED INTO PATIENT ON OR ABOUT (B)(6), 2011 AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS ('DVT) AND PULMONARY EMBOLUI ('PE'). ON OR ABOUT (B)(6), 2022 PATIENT UNDERWENT DIAGNOSTIC IMAGING. EXAMINATION OF THE IMAGING BY A QUALIFIED EXPERT RADIOLOGIST SHOWED MULTIPLE STRUTS FRACTURED IN THE VICINITY OF THE LOWER THORACIC SPINE. PATIENT IS AT RISK FOR FUTURE MIGRATIONS, FRACTURES AND PERFORATIONS FROM THE RETAINED VENATECH LP FILTER, AND FACES NUMEROUS HEALTH RISKS, INCLUDING THE RISK OF DEATH. PATIENT WILL REQUIRE ONGOING MEDICAL CARE AND MONITORING FOR THE REST OF HIS LIFE. IT SHOULD BE NOTED THE ACTUAL PRODUCT CODE WAS NOT LISTED IN THE DOCUMENT AND A BATCH NUMBER WAS NOT PROVIDED TO ASSIST IN VERIFY THE ACTUAL PRODUCT CODE. THE PRODUCT CODE USED IS THE CODE FOR THE VENA TECH LP FILTER AS LISTED IN THE DOCUMENT.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 15583866 ↗
• InjuryOct 11, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4) AS REPORTED BY THE USER FACILITY: VENATECH LP FILTER IMPLANTED INTO PATIENT ON OR ABOUT (B)(6), 2004 AFTER BEING DIAGNOSED WITH DVT AND PE. ON OR ABOUT (B)(6), 2021 PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN OF HIS ABDOMEN. EXAMINATION BY A QUALIFIED EXPERT RADIOLOGIST SHOWED MULTIPLE STRUTS PERFORATIONS THROUGH WALL OF HIS INFERIOR VENA CAVA WITH ONE STRUT ABUTTING THE DUODENUM, IT ALSO SHOWED A STRUT IN CONTACT WITH A VERTEBRAL BODY CAUSING A BONY REACTION. PATIENT IS AT RISK FOR FUTURE MIGRATIONS, FRACTURES AND PERFORATIONS FROM THE RETAINED VENATECH LP FILTER, AND FACES NUMEROUS HEALTH RISKS, INCLUDING THE RISK OF DEATH. PATIENT WILL REQUIRE ONGOING MEDICAL CARE AND MONITORING FOR THE REST OF HIS LIFE. IT SHOULD BE NOTED THE ACTUAL PRODUCT CODE WAS NOT LISTED IN THE DOCUMENT AND A BATCH NUMBER WAS NOT PROVIDED TO ASSIST IN VERIFY THE ACTUAL PRODUCT CODE. THE PRODUCT CODE USED IS THE CODE FOR THE VENA TECH LP FILTER AS LISTED IN THE DOCUMENT.

  Patient problems: Extraskeletal ossification; Foreign Body In Patient; Great Vessel Perforation

  MAUDE report 15583725 ↗
• InjuryAug 18, 2022Activation Failure; Activation Failure

  THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). AS REPORTED BY THE USER FACILITY: "WHILE ATTEMPTING TO PLACE A VENATECH LP WHEN THE DEVICE DEPLOYED FROM THE CATHETER THE FILTER NEVER OPENED. IT ENDED UP UNOPENED IN THE PATIENT'S RIGHT ATRIUM. AFTER MANY ATTEMPTS WE SUCCESSFULLY RETRIEVED THE DEVICE WITHOUT ANY KNOWN HARM TO OUR PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15251464 ↗
• InjuryAug 12, 2022Activation Failure; Activation Failure

  "WHILE ATTEMPTING TO PLACE A VENATECH LP WHEN THE DEVICE DEPLOYED FROM THE CATHETER THE FILTER NEVER OPENED. IT ENDED UP UNOPENED IN THE PATIENT'S RIGHT ATRIUM. AFTER MANY ATTEMPTS WE SUCCESSFULLY RETRIEVED THE DEVICE WITHOUT ANY KNOWN HARM TO OUR PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15215908 ↗
• MalfunctionJan 7, 2022Activation Problem; Activation Problem

  FILTER LEGS DID NOT EXPAND FULLY DESPITE MANIPULATION WITH CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13190078 ↗
• InjuryAug 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  "FILTER WAS IMPLANTED INTO PATIENT ON OR ABOUT (B)(6) 2015. ON (B)(6) 2017, PATIENT UNDERWENT VENOUS SURGERY. A VENOGRAPHY WAS PERFORMED. THE BRAUN VENA TECH IVC FILTER WAS OCCLUDED. A CATHETER PLACEMENT PROCEDURE WAS ALSO PERFORMED IN THE IVC ALONG WITH IVC ANGIOPLASTY AND STENTING. ON (B)(6) 2017, PATIENT UNDERWENT A COMPUTED TOMOGRAPHY SCAN (CT SCAN). EXAMINATION OF THE CT SCAN BY A QUALIFIED EXPERT RADIOLOGIST REVEALED THAT THE FILTER WAS PRESSED AGAINST THE RIGHT LATERAL SIDEWALL OF THE IVC BY A STENT."

  Patient problems: Thromboembolism

  MAUDE report 12376906 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "FILTER WAS IMPLANTED INTO PATIENT ON OR ABOUT (B)(6) 2011. ON (B)(6) 2017, PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN ("CT SCAN") OF THE ABDOMEN AND PELVIS. ON (B)(6) 2019, A REVIEW OF THE (B)(6) 2017, CT SCAN WAS PERFORMED, REVEALING THE FILTER WAS IN FACT TILTED, WITH MULTIPLE STRUTS PERFORATING THE IVC."

  Patient problems: Perforation of Vessels

  MAUDE report 12376904 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "FILTER WAS IMPLANTED INTO PATIENT ON OR ABOUT (B)(6) 2006. ON (B)(6) 2017, PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN ("CT SCAN") OF THE ABDOMEN. EXAMINATION OF THE CT SCAN BY A QUALIFIED EXPERT RADIOLOGIST REVEALED THAT THE FILTER WAS TILTED WITH MULTIPLY STRUTS PERFORATING BEYOND THE IVC WALL."

  Patient problems: Perforation of Vessels

  MAUDE report 12376901 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "FILTER WAS IMPLANTED INTO PATIENT ON (B)(6) 2004. ON (B)(6) 2015, PATIENT UNDERWENT A CT SCAN OF THE ABDOMEN AND PELVIS. AT THAT TIME THE RADIOLOGIST READING THE IMAGES REPORTED THE PRESENCE OF AN IVC FILTER BUT GAVE NO FURTHER DESCRIPTION. THE CT SCAN IMAGES WERE REVIEWED BY ANOTHER RADIOLOGIST ON (B)(6) 2017 AND FOR THE FIRST TIME IT WAS NOTED THAT THE VENA TECH IVC FILTER HAD PERFORATED THRU THE VENA CAVA WALL. MORE SPECIFICALLY, THE RADIOLOGIST FOUND: THE LEFT ANTEROLATERAL AND RIGHT POSTEROLATERAL STRUTS HAVE PENETRATED THROUGH THE IVC WALL."

  Patient problems: Perforation of Vessels

  MAUDE report 12376896 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "THE FILTER WAS IMPLANTED INTO PATIENT ON OR ABOUT (B)(6) 2009. ON (B)(6) 2017, PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN ("CT SCAN") OF THE CHEST. EXAMINATION OF THE CT SCAN BY A QUALIFIED EXPERT RADIOLOGIST REVEALED THAT THE DISTAL FILTER PRONGS WERE PERFORATING THROUGH THE IVC. TWO PRONGS ARE ABUTTING THE ABDOMINAL AORTA."

  Patient problems: Perforation of Vessels

  MAUDE report 12376894 ↗
• InjuryJul 28, 2021Unintended Movement; Unintended Movement

  "FILTER WAS IMPLANTED INTO PATIENT ON OR ABOUT (B)(6), 2010. ON (B)(6), 2018, PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN ("CT SCAN") OF THE CHEST. EXAMINATION OF THE CT SCAN BY A QUALIFIED EXPERT RADIOLOGIST REVEALED PERFORATION OF ONE (1) OF THE LEFT LEGS OF THE FILTER, EXTENDING APPROXIMATELY 4 MM OUTSIDE THE MARGIN OF THE IVC."

  Patient problems: Perforation of Vessels

  MAUDE report 12239137 ↗
• InjuryJul 28, 2021Unintended Movement; Unintended Movement

  "FILTER WAS IMPLANTED INTO PATIENT ON OR ABOUT (B)(6) 2010. ON OR ABOUT (B)(6) 2014, PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN ("CT SCAN") OF THE ABDOMEN. ON (B)(6) 2017, A REVIEW OF THE (B)(6) 2014, CT SCAN WAS PREFORMED, REVEALING MULTIPLE STRUTS PENETRATING THE IVC WALL."

  Patient problems: Perforation of Vessels

  MAUDE report 12239131 ↗
• InjuryJul 28, 2021Unintended Movement; Unintended Movement

  "FILTER WAS IMPLANTED INTO PATIENT ON OR ABOUT (B)(6) 2014. ON (B)(6) 2017, PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN ("CT SCAN") OF THE CHEST. EXAMINATION OF THE CT SCAN BY A QUALIFIED EXPERT RADIOLOGIST REVEALED THAT THE FILTER IS TILTED WITH MULTIPLE STRUTS PERFORATING THE IVC."

  Patient problems: Perforation of Vessels

  MAUDE report 12239128 ↗
• InjuryJun 19, 2020Migration; Migration

  FILTER WAS IMPLANTED IN PATIENT (B)(6) 2011 AND MIGRATED INTO THE HEART. THE PATIENT HAD SURGERY TO REMOVE THE FILTER. ON (B)(6) 2016 PATIENT UNDERWENT AN ECHOCARDIOGRAM OF THE CHEST WHICH DEMONSTRATED THAT THE FILTER HAD MIGRATED IN ITS ENTIRETY TO THE HEART. ON (B)(6) 2016 PATIENT UNDERWENT AN X-RAY OF THE CHEST THAT CONFIRMED THE ENTIRE FILTER HAD MIGRATED INTO THE RIGHT ATRIUM. ON (B)(6) 2016 THE PATIENT UNDERWENT CONSULTATION WITH PHYSICIANS WHO STATED THE FILTER IS IN THE RIGHT ATRIUM WITH THE HEAD ORIENTED TOWARD THE IVC AND THE PRONGS FACING TOWARD THE SVC IN DISARRAY THUS MAKING PERCUTANEOUS REMOVAL IMPOSSIBLE. PATIENT UNDERWENT OPEN STERNOTOMY TO REMOVE THE FILTER. DURING THE REMOVAL THE FILTER WAS IN THE RIGHT ATRIUM WITH THE APEX IN THE CORONARY SINUS AND TWO STRUTS OF THE FILTER WERE PENETRATING THE ANTERIOR AND SEPTAL TRICUSPID VALVE LEAFLETS, REQUIRING REPAIR OF THE TRICUSPID VALVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10174210 ↗
• DeathMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "SUBJECT IS A 69 YEAR OLD FEMALE WITH HISTORY OF HYPERTENSION, SHORTNESS OF BREATH, CURRENT MALIGNANCY, CURRENT AND PAST HISTORY OF RESOLVED BILATERAL DVT LIMITED TO BELOW POPLITEAL VEIN. CONTRAINDICATION TO ANTICOAGULATION DUE TO RECURRENT DVT ON ANTICOAGULANTS; DEVELOPED DVT ON AVASTAN. ON (B)(6) 2016, SUBJECT WAS ADMITTED TO HOSPITAL, CONSENTED, VENATECH® LP VENA CAVA FILTER WAS PLACED WITHOUT COMPLICATION, AND DISCHARGED. ON (B)(6) 2017, SUBJECT UNDERWENT A VENOUS LYSIS FOR LOWER EXTREMITY DVT THAT EXTENDED UP INTO THE INFRARENAL IVC. POST PROCEDURE IN RECOVERY FOR OBSERVATION THE SUBJECT SHOWED PROGRESSIVE ALTERED MENTAL STATUS. SUBJECT MOVED TO CT DEMONSTRATING A LARGE RIGHT TEMPOROPARIETAL INTRAPARENCHYMAL HEMORRHAGE. SUBJECT WAS INTUBATED, AND LATER IN THE EVENING THE FAMILY CHOSE TO EXTUBATE THE SUBJECT AS THEY DID NOT WANT PT TO UNDERGO SURGERY. THE INTRACEREBRAL HEMORRHAGE WAS CONSIDERED EXPECTED, AND NOT RELATED TO THE IVC FILTER OR PROCEDURE. ALSO ON (B)(6) 2017, A CT OF ABDOMEN AND PELVIS WAS OBTAINED FOR POSSIBLE COLITIS WHICH SHOWED EXTENSIVE THROMBUS OF THE IVC EXTENDING FROM THE FILTER DOWN TO THE COMMON ILIAC VEIN. STRANDING CONCERNING FOR THROMBOPHLEBITIS. SUBJE

  Patient problems: Thrombosis; Thrombosis/Thrombus

  MAUDE report 10101685 ↗
• DeathMay 19, 2020Migration; Migration

  ON (B)(6) 2020 VENATECH LP FILTER WAS PLACED FOR LOWER EXTREMITY DVT AND PE WITH CONTRAINDICATION TO ANTICOAGULATION. DEVICE WAS PLACED FROM THE RIGHT INTERNAL JUGULAR APPROACH. FILTER DEPLOYED APPROPRIATELY AND IN INFRARENAL LOCATION WITH EXPANSION OF STRUTS. ON (B)(6) 2020 A CT SCAN WAS PERFORMED AND IVC FILTER WAS SEEN TO HAVE MIGRATED TO INTRAHEPATIC IVC RIGHT ATRIUM. FILTER APPEARED DISTORTED. NO CENTRAL INE PLACEMENTS, CPR, TRAUMA OR CARDIOLOGY PROCEDURES WERE NOTED. DIAMETER OF THE VENA CAVA BEFORE IMPLANTATION: 2.3CM. FILTER DEPLOYMENT LEVEL: L2, L3. PATIENT HAD NOT UNDERGONE ANY SURGERY SINCE THE FILTER PLACEMENT. PATIENT CO-MORBIDITIES: PANCREATIC CANCER. THERE WERE NO PATIENT SYMPTOMS PRIOR TO THE CT SCAN. PATIENT PASSED AWAY OF ACUTE KIDNEY RENAL FAILURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10069901 ↗
• InjuryMar 5, 2020Migration or Expulsion of Device

  ON (B)(6) 2020 A B. BRAUN VENATECH LP PERMANENT IVC FILTER WAS PLACED FOR LOWER EXTREMITY / DVT AND PE WITH CONTRAINDICATION TO ANTICOAGULATION. DEVICE WAS PLACED FROM RIGHT INTERNAL JUGULAR APPROACH. FILTER DEPLOYED APPROPRIATELY AND IN INFRARENAL LOCATION WITH EXPANSION OF STRUTS. ON (B)(6) 2020, IVC FILTER WAS SEEN TO HAVE MIGRATED TO INTRAHEPATIC IVC / RIGHT ATRIUM. FILLER APPEARED DISTORTED. NO CENTRAL LINE PLACEMENTS. CPR, TRAUMA OR CARDIOLOGY PROCEDURES WERE NOTED IN THE INTERVAL. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9800030 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT HAS HISTORY OF HYPERTENSION, FORMER SMOKER >1 YEAR PRIOR TO ENROLLMENT, CURRENT MALIGNANCY, SOB, AND RLE COMMON FEMORAL DVT. CONTRAINDICATION TO ANTICOAGULATION DUE TO ABNORMAL PLATELET COUNT. SUBJECT WAS ADMITTED TO HOSPITAL ON (B)(6) 2017. ON (B)(6) 2017 PT WAS CONSENTED AND LP FILTER WAS PLACED WITHOUT COMPLICATION. PATIENT WAS DISCHARGED ON (B)(6) 2017. ON (B)(6) 2017, SUBJECT WAS SENT FOR A CT A/P WITHOUT CONTRAST WHICH DEMONSTRATED ACUTE THROMBOSIS FROM THE IVC FILTER DOWN INTO THE BILATERAL COMMON ILIAC VEINS WITH STRANDING AROUND THE IVC. PATIENT WAS CONTINUED ON ANTICOAGULATION WITH HEPARIN, SYMPTOMATIC CONTROL FOR PAIN, AND LASIX FOR EDEMA. EVENTUALLY PAIN AND SWELLING STARTED IMPROVING. REPEAT CT SCAN REVEALED STABLE CLOT BURDEN (DATE NOT PROVIDED). HEPARIN GTT WAS CHANGED TO LOVENOX AND TITRATED BASED ON ANTI-XA TO 60 MG BID. ON (B)(6) 2018, CT W/CONTRAST IMPRESSION SHOWED NO EVIDENCE OF THROMBOSIS. SUBJECT ON ASPIRIN AND RIVAROXABAN 10 MG DAILY. FILTER THROMBOSIS WAS CONSIDERED RESOLVED WITHOUT SEQUELEA ON (B)(6) 2018. THE PI CONSIDERED THE EVENT EXPECTED AND POSSIBLY RELATED TO THE DEVICE.

  Patient problems: Thrombosis

  MAUDE report 9757798 ↗
• InjuryJan 19, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INITIAL ATTEMPT AT PLACING A VENATECH LP FILTER WAS COMPLICATED BY THE FILTER NOT OPENING UP AND DEPLOYING PROPERLY. THIS RESULTED IN FILTER MIGRATION INTO THE RIGHT VENTRICLE AND ULTIMATELY INTO THE RIGHT LOWER LOBE PULMONARY ARTERY. THE FILTER NEVER PROPERLY DEPLOYED. ULTIMATELY, A DECISION WAS MADE TO LEAVE THE FILTER AS AN INTENTIONAL FOREIGN BODY, AS THE RISK OF ATTEMPTING TO RETRIEVE IT OUTWEIGHED THE BENEFIT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9604855 ↗