Greenfield™ M001503000Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 08714729114659), received between Aug 16, 2018 and Sep 28, 2022 — classified as 49 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (36 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 55 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE FILTER WAS TILTED AND HAD PERFORATED THE SURROUNDING STRUCTURES. ON (B)(6), 2013, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. THE PATIENT WAS PREVIOUSLY IMPLANTED WITH A TEMPORARY INFERIOR VENA CAVA (IVC) FILTER, WHICH WAS REMOVED AND REPLACED WITH A GREENFIELD FILTER. ON (B)(6), 2020, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN TO EVALUATE THE PLACEMENT OF THE IVC FILTER. THE FILTER WAS OBSERVED TO BE TILTED LESS THAN 10 DEGREES. ADDITIONALLY, THE FILTER STRUTS HAD PERFORATED BEYOND THE IVC WALL, MAXIMALLY MEASURING 4 MM. NO ADJACENT ORGANS WERE SIGNIFICANTLY IMPACTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15499696 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FILTER WAS PERFORATING ADJACENT STRUCTURES. ON (B)(6), 2010, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. THE PATIENT HAD A HISTORY OF DEEP VENOUS THROMBOSIS (DVT) WITH PULMONARY EMBOLISM. ON (B)(6) 2019, THE PATIENT RECEIVED AN ABDOMINAL AND PELVIC CT SCAN. THE STRUTS OF THE INFERIOR VENA CAVA (IVC) FILTER WERE NOTED TO HAVE PERFORATED THE IVC. ONE STRUT WAS PERFORATING PROXIMALLY INTO THE RIGHT GONADAL VEIN AND ANOTHER WAS ABUTTING THE POSTERIOR WALL OF THE THIRD PORTION DUODENUM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15454587 ↗
• MalfunctionSep 8, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE DEVICE WAS TILTED. ON (B)(6), 2001, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. THE PATIENT HAD A HISTORY OF DEEP VENOUS THROMBOSIS (DVT) IN THE RIGHT LOWER EXTREMITY. IN (B)(6)2022, IT WAS REPORTED THERE WAS EVIDENCE OF INFERIOR VENA CAVA (IVC) FILTER TILT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15381181 ↗
• InjuryAug 25, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE DEVICE WAS TILTED AND HAD PERFORATED THE MESENTERY. ON (B)(6) 2003, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. THE PATIENT WAS THE VICTIM OF A HIGH SPEED COLLISION WHICH RESULTED IN DAMAGE TO THE BILATERAL LOWER EXTREMITIES. ON (B)(6) 2019, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN TO EVALUATE INFERIOR VENA CAVA (IVC) FILTER PLACEMENT. THERE WAS A MILD TILT OF THE LONG AXIS OF THE FILTER WITH THE CEPHALAD APEX ABUTTING THE ANTERIOR WALL OF THE IVC. THERE WAS EVIDENCE OF SEVERAL PERFORATED FILTER STRUTS. THERE WAS FILTER STRUT PERFORATION ALONG THE POSTERIOR LEFT LATERAL ASPECT EXTENDING INTO THE ADJACENT ADIPOSE TISSUE BY APPROXIMATELY 3 MM, ABUTTING THE ANTERIOR LONGITUDINAL LIGAMENT. THERE WAS FILTER STRUT PERFORATION ALONG THE ANTERIOR ASPECT OF THE IVC EXTENDING APPROXIMATELY 4 MM INTO THE ADJACENT ADIPOSE TISSUE. THERE WAS FILTER STRUT PERFORATION ALONG THE RIGHT LATERAL ASPECT OF THE IVC EXTENDING APPROXIMATELY 4 MM INTO THE ADJACENT ADIPOSE TISSUE. FINALLY, THERE WAS FILTER STRUT PERFORATION ALONG THE POSTERIOR ASPECT OF THE IVC EXTENDING APPROXIMATELY 5 MM INTO THE ADJACENT ADIPOSE TISSUES ABUTTING THE ANTERIOR LONGITUDINAL LIGAMENT. NO FUR

  Patient problems: Perforation

  MAUDE report 15299065 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE HAD PERFORATED THE INFERIOR VENA CAVA (IVC) AND WAS ABUTTING THE PANCREAS. ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. THE PATIENT WAS EXPERIENCING DEEP VEIN THROMBOSIS (DVT) WITH ACUTE PULMONARY EMBOLISM DUE TO ANEMIA. IN (B)(6) 2018, THE PATIENT RECEIVED A CT SCAN. THE IVC FILTER WAS SHOWN WITH STRUT EROSION WITHOUT PENETRATION OF ADJACENT STRUCTURES. ONE OF THE STRUTS WAS SOMEWHAT CLOSE TO THE HEAD OF THE PANCREAS. ON (B)(6) 2019, THE PATIENT RECEIVED A PHYSICAL EXAM, DURING WHICH THE (B)(6) 2018 CT SCAN RESULTS WERE REVIEWED. THE FILTER STRUT EROSION WAS OBSERVED. DUE TO THE PATIENT'S HISTORY OF PARASTOMAL HERNIA AND STOMA, AND THE PATIENT NOT EXPERIENCING ANY SYMPTOMS, THE PHYSICIAN DID NOT RECOMMEND THAT THE FILTER BE REMOVED AT THAT TIME.

  Patient problems: Perforation

  MAUDE report 15298882 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VESSEL PERFORATION OCCURRED. ON (B)(6) 2005, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER UTILIZING AN INTERNAL JUGULAR VEIN APPROACH. THE PATIENT WAS SUFFERING FROM ACUTE DEEP VENOUS THROMBOSIS WITH A FREE-FLOATING PROXIMAL COMPONENT. THE DEVICE WAS DEPLOYED UNDER REAL TIME FLUOROSCOPIC GUIDANCE. THE STRUTS WERE SEEN TO DEPLOY ON AXIS AS THE DEVICE SAT COMFORTABLY IN THE INFERIOR VENA CAVA (IVC) AT ABOUT THE L3 LEVEL. THE IMPLANT PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. ON (B)(6) 2019, THE PATIENT UNDERWENT AN ABDOMINAL CT SCAN WITHOUT CONTRAST. THE GREENFIELD FILTER WAS OBSERVED WITH THE SUPERIOR TIP 2 CM INFERIOR TO THE RENAL VEINS, WITH NO SIGNIFICANT TILT AND NO FRACTURED STRUTS IDENTIFIED. ALL 6 LEGS OF THE FILTER APPEARED TO PERFORATE THE IVC BY APPROXIMATELY 3 MM. THERE WAS NO VASCULAR OR ORGAN PENETRATION OF THE PERFORATED STRUTS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15239294 ↗
• InjuryApr 4, 2022Positioning Problem; Positioning Problem

  ON (B)(6) 2005, THE PATIENT WAS SURGICALLY IMPLANTED WITH A GREENFIELD TITANIUM VENA CAVA FILTER. ON OR ABOUT (B)(6) 2020, THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN ("CT SCAN") OF HER ABDOMEN AND PELVIS, WHICH REVEALED THE FOLLOWING: THE IVC FILTER TILTED 12 DEGREES, ABUTS THE ANTERIOR WALL OF THE IVC, AND PERFORATES BEYOND THE VENA CAVA WALL (5 MM MESENTERIC AND 3 MM VERTEBRAL PERFORATION).

  Patient problems: Perforation

  MAUDE report 13999262 ↗
• InjuryMay 28, 2021Positioning Problem; Migration; Positioning Problem; Migration

  ON (B)(6) 2003, THE PATIENT WAS SURGICALLY IMPLANTED WITH A GREENFIELD TITANIUM VENA CAVA FILTER. ON (B)(6) 2019, THE PATIENT RECEIVED A COMPUTERIZED TOMOGRAPHY (CT) SCAN, WHICH REVEALED THE FOLLOWING: THE STRUTS FROM THE IMPLANTED FILTER HAD PERFORATED THE INFERIOR VENA CAVA (IVC) WALL, ONE STRUT HAD PERFORATED THE SMALL BOWEL, AND THERE WAS A SMALL BOWEL OBSTRUCTION POSSIBLY CAUSED BY THE MIGRATION OF THE IVC FILTER INTO THE SMALL BOWEL. ON (B)(6) 2019, THE PATIENT HAD A OPEN LAPAROTOMY SURGERY TO REMOVE AN IVC FILTER STRUT AND REPAIR ENTEROTOMY. THE STRUT HAD SUBSTANTIALLY MIGRATED TO THE IVC WALL, THE FILTER WAS TILTED, AND ANOTHER STRUT PERFORATED THE IVC WALL. THE STRUT WAS FOUND ENCAPSULATED WITHIN THE SMALL BOWEL CAUSING THE OBSTRUCTION. HEAVY SCISSORS WERE USED TO DIVIDE THE STRUT AND FREE THE BOWEL. THE REMAINDER OF THE FILTER REMAINS IN AN UNSAFE LOCATION THAT COULD REQUIRE FURTHER SURGERY.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion; Perforation

  MAUDE report 11901355 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION OCCURRED. A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2002. ON (B)(6) 2003 IT WAS NOTED THAT PERFORATION HAD OCCURRED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 11385573 ↗
• InjuryOct 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BROKE AND BECAME DETACHED. A GREENFIELD FILTER WAS ATTEMPTED TO BE IMPLANTED IN (B)(6) 2020. DURING THE PROCEDURE THE DILATOR THAT WAS USED TO INTRODUCE THE DEVICE BROKE OFF IN THE PATIENTS VESSEL. THE PHYSICIAN HAD TO OPEN THE PATIENT UP IN ORDER TO RETRIEVE THE BROKEN PIECE AND TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. UPDATE: REPORTED VIA USER FACILITY MEDWATCH # (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10655830 ↗
• InjuryMay 13, 2020Positioning Failure; Positioning Problem; Positioning Failure; Positioning Problem

  A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2007. ON AN UNKNOWN DATE IT WAS NOTED THAT PERFORATION AND TILT OCCURRED. IT WAS FURTHER REPORTED THAT A GREENFIELD INFERIOR VENA CAVA (IVC) FILTER WAS IMPLANTED DUE TO STATUS POST MOTOR VEHICLE ACCIDENT, FAILED PROPHYLACTIC ANTICOAGULATION AND DEVELOPED A THROMBUS DESPITE THIS. LOWER EXTREMITY ULTRASOUND SHOWED INCOMPRESSIBILITY OF VEIN IN THE LEFT FEMORAL SYSTEM. SHE ALSO REQUIRED PROLONGED IMMOBILITY. THE IVC FILTER WAS IMPLANTED IN AN INFRARENAL POSITION HOWEVER, WHEN IT WAS DEPLOYED IT WAS NOTED THAT THERE WAS NOT ADEQUATE OPENING OF THE LEGS OF THE FILTER AND ONLY ONE STRUT SEEMED TO OPEN IN THE PROPER MANNER. THE OTHER STRUTS WERE LOCATED IN THE LEFT LATERAL POSITION AND DID NOT APPEAR TO BE SATISFACTORILY DEPLOYED. IT WAS DETERMINED IT WAS A NONDEPLOYMENT OF THE FILTER WHICH WAS POTENTIAL RISK FOR EMBOLIZATION AND THE PATIENT SHOULD UNDERGO PLACEMENT OF A MORE PROXIMAL INFRARENAL IVC FILTER. AN ADDITIONAL VENOGRAM CONFIRMED MAL-DEPLOYMENT OF THE FIRST IVC FILTER, THE STRUTS WERE ESSENTIALLY CROSSED ON THEMSELVES. A SMALL CATHETER WAS THEN PASSED THROUGH THE JUGULAR SHEATH IN AN ATTEMPT TO PUSH THE STRUTS OPEN. ONE STRUT DID OPEN,

  Patient problems: No Code Available; Perforation

  MAUDE report 10054155 ↗
• MalfunctionApr 24, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE FILTER WAS NOT COMPLETELY OPENED. ON (B)(6) 2008 THAT TWO GREENFIELD IVC FILTERS WERE IMPLANTED. ACCESS WAS OBTAINED VIA THE RIGHT INTERNAL JUGULAR VEIN. AN INTRODUCER CATHETER AND A J-WIRE WERE ADVANCED TO THE SUPERIOR VENA CAVA VIA FLUOROSCOPIC GUIDANCE. A DILATOR WAS PASSED OVER THE GUIDEWIRE AND AN ATTEMPT WERE MADE TO REMOVE THE INITIAL SHORT GUIDEWIRE FOR A LONGER GUIDEWIRE. REPEATED ATTEMPTS WERE MADE TO ADVANCE THE DILATOR OVER THE GUIDEWIRE AND INTO THE SUPERIOR AND INFERIOR VENA CAVA. AFTER MULTIPLE ATTEMPTS THE LONG GUIDEWIRE WAS REPLACED WITH THE INITIAL SHORT GUIDEWIRE WHICH WAS ADVANCED INTO THE INFERIOR VENA CAVA AND THE DILATOR WAS ADVANCED THROUGH THE ATRIUM AND INTO THE INFERIOR VENA CAVA. THE GREENFIELD FILTER SHEATH AND DILATOR WERE PASSED OVER THE GUIDEWIRE AND ADVANCED THROUGH THE INFERIOR VENA CAVA TO THE BIFURCATION. THE DILATOR AND GUIDEWIRE WERE REMOVED AND THE INTRODUCER CARRYING THE FILTER WAS PASSED THROUGH THE SHEATH TO IN THE INFERIOR VENA CAVA. THE FILTER WAS DISCHARGED INFERIOR TO THE L3-L4 VERTEBRA, THEREFORE A SECOND IVC FILTER WAS PLACED THROUGH THE SHEATH TO THE L2-L3 LEVEL AND WAS DISCHARGED. THE SECOND FILTER WAS ANGUL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9995756 ↗
• InjuryApr 10, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2009 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTATED TOMOGRAPHY (CT) SCAN REVEALED THE FILTER WAS POSITIONED BELOW THE RENAL VEINS. SOME OF THE FILTER STRUTS HAVE PENETRATED THROUGH THE WALL OF THE INFERIOR VENA CAVA (IVC) INTO THE PERICAVAL/MESENTERIC FAT.

  Patient problems: Perforation

  MAUDE report 9948770 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2007, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD INFERIOR VENA CAVA (IVC) FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED TILT AND PERFORATION. THE IVC FILTER WAS IN THE INFRARENAL SEGMENT, THE APEX OF THE FILTER WAS BELOW THE RENAL VEINS. THERE WAS NO SIGNIFICANT TILT IN THE ANTERIOPOSTERIOR (AP) DIMENSION. THE SUPERIOR APEX OF THE FILTER CONTACTED THE ANTERIOR WALL OF THE IVC. WITH REGARD TO PERFORATION, DISTAL STRUTS PERFORATION POSTERIORLY TOWARD THE LEFT ON AXIAL IMAGE, ABUTS THE POSTERIOR WALL OF THE AORTA EXTERNALLY. ADJACENT TO THIS THERE IS CONTACT OF ONE OF THE STRUTS WITH AN ANTERIOR INTRAVERTEBRAL OSTEOPHYTES. ALSO TOWARD THE RIGHT AXIAL IMAGE, ONE OF THE STRUTS PERFORATE THE IVC AND CONTACT THE ADJACENT SMALL BOWEL LOOP. ANTERIOR STRUTS SHOW PERFORATION INTO THE ADJACENT FAT. THERE IS NO SIGNIFICANT BROKEN OR BENT FILTER COMPONENT AND NO EVIDENCE OF IVC STENOSIS.

  Patient problems: Perforation

  MAUDE report 9947472 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2006 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) CAN OF THE ABDOMEN REVEALED TILT AND INJURY. THERE WAS A SLIGHT POSTERIOR TILT OF APPROXIMATELY 2.5 DEGREES. THE APEX OF THE FILTER LIED ALONG THE POSTERIOR INFERIOR VENA CAVA (IVC) WALL. THERE WERE SIX INTACT STRUTS SEEN. THE ANTERIOR STRUT APPEARED TO EXTEND BEYOND THE IVC WALL BY APPROXIMATELY 1MM ANTERIORLY. THE POSTERIOR STRUT QUESTIONABLE EXTENDED 1 TO 2MM. THERE WAS APPARENT SLIGHT EXTENSION OF THE RIGHT STRUT BEYOND THE IVC WALL APPROXIMATELY 2 TO 3MM LATERAL TO RIGHT AS WELL AS ADJACENT STRUT EXTENDING APPROXIMATELY 2 TO 3MM LATERALLY TO THE RIGHT. THERE WAS APPARENT EXTENSION OF POSTERO LATERAL RIGHT STRUT MEASURING APPROXIMATELY 2MM LATERALLY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Perforation

  MAUDE report 9946841 ↗
• MalfunctionApr 9, 2020Migration; Migration

  IT WAS REPORTED A MIGRATION OCCURRED. ON (B)(6) 2006, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED MIGRATION. THE INFERIOR VENA CAVA (IVC) FILTER WAS IN PLACE WITH THE APEX OF THE FILTER LOCATED 5.9 CM BELOW THE LEVEL OF THE RENAL VEINS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9944096 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 1998, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT FILTER ONE WAS LOCATED WITHIN THE INFRARENAL PORTION OF THE INFERIOR VENA CAVA (IVC) LOCATED BELOW THE RENAL VEINS. THE SUPERIOR PORTION OF THE FILTER WAS TILTED MEDIALLY AND ABUTTED THE WALL OF THE IVC. MANY STRUTS PERFORATED THE IVC WALL. FILTER TWO WAS LOCATED WITHIN THE RIGHT EXTERNAL ILIAC VEIN. MANY OF THE DISTAL STRUTS PERFORATED THE WALL OF THE IVC. ONE STRUT PERFORATED THE RIGHT INTERNAL ILIAC VEIN.

  Patient problems: Perforation

  MAUDE report 9943743 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERFORATION OCCURRED. AT AN UNKNOWN TIME, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED THAT AN INFRARENAL INFERIOR VENA CAVA (IVC) FILTER IS PRESENT. THERE WAS SOME EXTRA VENOUS EXTENSION OF THE RIGHT LATERAL 3 LEGS INTO THE PERIVASCULAR FAT. THERE WAS NO EVIDENCE OF INTRAOSSEOUS OR AORTIC PENETRATION. THE ANTERIOR MOST LEG ABUTS THE GONDAL VEIN. THERE WAS NO TILT, STENOSIS, FRACTURE OR MIGRATION NOTED. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT PLACEMENT OF THEIR IVC FILTER ON (B)(6) 2009.

  Patient problems: Perforation

  MAUDE report 9943619 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 1996 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN REVEALED 3 OF THE 6 LEGS OF THE FILTER EXTENDED BEYOND THE WALL BY 2MM. NO ADJACENT ORGANS WERE INVOLVED. THE TIP OF THE FILTER TOUCHED THE POSTERIOR WALL OF THE CAVA AND THE TIP IS AT THE LEVEL OF THE RIGHT RENAL VEIN AND 2CM BELOW LEFT RENAL VEIN. INFERIOR PORTION OF FILTER IS 6.4CM ABOVE THE ILIAC VEINS.

  Patient problems: Perforation

  MAUDE report 9943532 ↗
• InjuryApr 8, 2020Positioning Problem; Positioning Problem

  IN (B)(6) 2007 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. IN (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A 15 DEGREE LEFTWARD TILT AND A MINIMAL MESENTERIC PERFORATION INVOLVING THE DISTAL INFERIOR FILTER LIMBS MEASURING 2MM.

  Patient problems: Perforation

  MAUDE report 9939152 ↗
• InjuryApr 8, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2000 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2018 A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE FILTER IS ANGLED SEVEN DEGREES TO THE RIGHT. MILD TO MODERATE WALL PROTRUSION OF ALL SIX STRUTS WITHOUT SIGNIFICANT IMPINGEMENT ON ADJACENT STRUCTURES. ANTERIOR STRUTS TERMINATE IN CLOSE PROXIMITY TO THE POSTERIOR DUODENAL WALL BUT DO NOT APPEAR TO EXTEND INTO THE LUMEN.

  Patient problems: Perforation

  MAUDE report 9938511 ↗
• InjuryApr 8, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2009 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN/PELVIS-INFRARENAL REVEALED THERE IS SLIGHT PENETRATION OF THE CAVAL WALL BY ALL OF THE FILTER STRUTS AND CONSIDERED TO BE WITHIN NORMAL LIMITS. THERE WAS NO SURROUNDING INFLAMMATORY CHANGE. ON (B)(6) 2019 A CT OF THE ABDOMEN REVEALED THE FILTER HAD A 6 DEGREE TILT AND THERE WAS AORTIC PERFORATION.

  Patient problems: Perforation

  MAUDE report 9937916 ↗
• InjuryApr 8, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2006, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THERE WAS AN INFERIOR VENA CAVA (IVC) FILTER IN PLACE BELOW LEVEL OF RENAL VEINS. PROXIMALLY FILTER WAS TILTED DORSALLY 30 DEGREES WITH RESPECT TO IVC. TWO ANTERIOR STRUTS EXTENDED BEYOND THE VESSEL WALL. THERE WAS NO RETROPERITOINEAL HEMATOMA AND THERE WAS NO STENOSIS.

  Patient problems: Perforation

  MAUDE report 9935629 ↗
• MalfunctionApr 8, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2004 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN REVEALED THE FILTER IS IN PLACE WITH ITS TIP ABOUT 2.4CM INFERIOR TO RENAL VEIN IVC CONFLUENCE. IVC FILTER TIP IS ALONG POSTERIOR WALL. NO FRACTURE OF STRUT. EXTRALUMINAL EXTENSION OF STRUT ALONG ANTERIOR AND RIGHT LATERAL ASPECT IS DEMONSTRATED MEASURING 3.5MM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9934955 ↗
• InjuryApr 8, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2010 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A VERY MILD LEFTWARD TILT OF THE INFERIOR VENA CAVA FILTER (IVC). A MESENTERIC PERFORATION WAS IDENTIFIED, WHERE THE INFERIOR ASPECT OF THE STRUTS PROJECTED 5MM BEYOND THE INFERIOR VENA CAVA (IVC) LUMEN.

  Patient problems: Perforation

  MAUDE report 9934333 ↗