Greenfield™ M001503010Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 08714729114666), received between Dec 20, 2017 and Sep 21, 2022 — classified as 54 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (43 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 64 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FILTER HAD PERFORATED THE MESENTERY. ON (B)(6) 2004, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. ON (B)(6) 2019, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN FOR AN UNSPECIFIED INJURY OF THE INFERIOR VENA CAVA (IVC). THE FILTER STRUTS WERE OBSERVED TO EXTEND BEYOND THE CONFINES OF THE IVC ON THE RIGHT SIDE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15461928 ↗
• InjurySep 13, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE FILTER WAS TILTED AND HAD PERFORATED THE MESENTERY. ON (B)(6) 2004, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. ON (B)(6) 2018, THE PATIENT RECEIVED AN ABDOMINAL AND PELVIC CT SCAN TO EVALUATE INFERIOR VENA CAVA (IVC) FILTER PLACEMENT. THE ANTERIOR AND RIGHT LATERAL STRUTS OF THE FILTER WERE OBSERVED TO EXTEND SLIGHTLY BEYOND THE BORDERS OF THE IVC. THERE WAS NO TILT OBSERVED AT THIS TIME. ON (B)(6) 2020, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN TO EVALUATE IVC FILTER PLACEMENT. THE UPPER APEX OF THE FILTER WAS TILTED ANTERIORLY AND TOWARD THE LEFT, ABUTTING THE LEFT ANTEROLATERAL IVC WALL. THE FILTER WAS TILTED 15 DEGREES OFF AXIS COMPARED WITH THE AXIS OF THE IVC. A SINGLE ANTERIOR TINE APPEARED TO PERFORATE THE IVC MINIMALLY. THERE WAS APPROXIMATELY 1 MM OF SEPARATION AT THE TIP OF THE TINE FROM THE ANTERIOR IVC WALL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15412492 ↗
• InjurySep 6, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE FILTER WAS TILTED AND THAT THE STRUTS HAD PERFORATED THE INFERIOR VENA CAVA (IVC). ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. THE PATIENT WAS AT AN ELEVATED RISK OF DEVELOPING A PULMONARY EMBOLISM (PE) FOLLOWING A GASTRIC BYPASS SURGERY. ON (B)(6) 2020, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN. IT WAS NOTED THAT THE IVC FILTER WAS TILTED WITH THE APEX OF THE FILTER CONTACTING THE RIGHT LATERAL WALL OF THE IVC. ONE OF THE FILTER STRUTS EXTENDED BEYOND THE WALL OF THE IVC LUMEN INTO THE ADJACENT RETROPERITONEAL FAT. ADDITIONAL, A FEW OF THE LEFT LATERAL STRUTS EXTENDED BEYOND THE IVC LUMEN, AND APPEARED TO ABUT THE ADJACENT AORTA. NO EVIDENCE OF STRUT FRACTURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15362123 ↗
• InjuryAug 23, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE DEVICE HAD TILTED AND PERFORATED THE DUODENUM RESULTING IN BLEEDING. ON (B)(6) 1994, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER IN THE INFERIOR VENA CAVA (IVC). ON (B)(6) 2016, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH REPORTS OF DARK STOOL, RECTAL BLEEDING, DIZZINESS, AND WEAKNESS. THE PATIENT REPORTED THAT THEIR IVC FILTER HAD MIGRATED, BUT THAT THE LOCATION HAD NOT CHANGED ON A RECENT CT SCAN FROM 2 DAYS PRIOR. ON (B)(6) 2016, THE PATIENT UNDERWENT AN ENDOSCOPY PROCEDURE OF THE DUODENUM. THIS REVEALED A SHALLOW ULCER IN THE SECOND PORTION OF THE DUODENUM. IT WAS OBSERVED THAT A METAL WIRE TYPE STRUCTURE WAS PENETRATING THE DUODENAL WALL, WITH THE END RUBBING AT THE ULCER BED. REVIEW OF PAST CT INDICATED THE IVC FILTER LEG WAS EXTENDING INTO THE DUODENUM RESULTING IN GASTROINTESTINAL BLEEDING. SURGICAL REMOVAL OF THE FILTER WAS RECOMMENDED. ON (B)(6) 2016, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY IN ORDER TO REMOVE THE IVC FILTER AND REPAIR THE DUODENUM. THE LEFT RENAL VEIN WAS ISOLATED, AND THE RIGHT RENAL VEIN WAS SOMEWHAT ADHERED FROM INFLAMMATION WHERE THE TIP OF THE FILTER LIKELY RESTED. IN ADDITION TO THE TINE EXTENDING INTO TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 15279730 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FILTER STRUTS EXTENDED BEYOND THE INFERIOR VENA CAVA (IVC). ON (B)(6), 2012, THE PATIENT WAS IMPLANTED WITH THE GREENFIELD FILTER DUE TO CHRONIC LEFT LEG DEEP VEIN THROMBOSIS (DVT) WITH SUSPICION OF PULMONARY EMBOLUS. ON (B)(6), 2017, THE PATIENT RECEIVED AN ABDOMINAL AND PELVIC CT SCAN FOR REPORTED ABDOMINAL PAIN. THE FILTER WAS VISUALIZED WITH NO EVIDENCE OF TILT OR FRACTURED STRUTS. THE STRUTS WERE OBSERVED TO EXTEND BEYOND THE CONFINES OF THE IVC BY APPROXIMATELY 2 MM. TWO ANTERIOR STRUTS CLOSELY ABUTTED THE POSTERIOR WALL OF THE FOURTH PORTION OF THE DUODENUM AS IT TRANSITS ANTERIOR TO THE IVC AND AORTA. A SINGLE STRUT WAS OBSERVED TO EXTEND INTO THE FAT BETWEEN THE IVC AND AORTA, CLOSELY ABUTTING THE RIGHT LATERAL WALL OF THE AORTA. THE REMAINING STRUTS EXTENDED INTO THE PERI IVC FAT WITHOUT INVOLVEMENT OF ADJACENT ANATOMIC STRUCTURES. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15271676 ↗
• InjuryApr 29, 2021Migration; Migration

  ON (B)(6) 2009, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2020, A SCAN REVEALED THAT THE IMPLANTED GREENFIELD FILTER HAD MIGRATED AND IS SLIGHTLY HIGH. TWO PRONGS HAD PERFORATED THE INFERIOR VENA CAVA (IVC) AND ONE PRONG HAD PERFORATED THE RIGHT LATERAL WALL OF THE AORTA.

  Patient problems: Perforation

  MAUDE report 11747257 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PERFORATION. A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2010. ON (B)(6) 2018 IT WAS NOTED THAT A PERFORATION HAD OCCURRED. THE STRUTS OF THE FILTER EXTEND BEYOND THE INFERIOR VENA CAVA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 11581830 ↗
• MalfunctionFeb 26, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE FILTER WAS TILTED. A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2004. ON (B)(6) 2004 IT WAS NOTED THAT THE FILTER WAS TILTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11385439 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2014. ON (B)(6) 2014 A THROMBUS WAS OBSERVED AND THE PATIENT WAS HYPOTENSIVE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension; Thrombosis/Thrombus

  MAUDE report 11362556 ↗
• InjuryMay 20, 2020Positioning Problem; Positioning Problem

  A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2005. THE PATIENT UNDERWENT A GREENFIELD FILTER PLACEMENT. FILTER NUMBER ONE WAS OPENED COMPLETELY WITHOUT ANY CROSSED LEGS BUT VENOGRAM SHOWED IVC NOT COMPLETELY PROTECTED. PATIENT THEN HAD FILTER NUMBER TWO PLACED, WHICH WAS PLACED ABOVE THE RENAL VEIN; IT WAS OPEN BUT ALSO SHOWED THE IVC NOT COMPLETELY PROTECTED. ON (B)(6) 2012 CT IMAGING SHOWED A THROMBUS WAS IDENTIFIED WITHIN ONE OF THE MEDIUM-SIZED RIGHT MIDDLE LOBE ARTERIES. EMBOLISM IS IDENTIFIED IN THE CENTRAL LEFT UPPER LOBE BRANCH WITH A TINY BIT OF THROMBUS WITHIN THE DESCENDING LEFT LOWER LOBE PULMONARY ARTERY. THE TIP OF THE INFERIOR FILTER IS SLIGHTLY ANGULATED TOWARDS RIGHT. THE PATIENT WAS CONTINUED ON ANTICOAGULATION THERAPY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Embolism; Thrombosis

  MAUDE report 10076476 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2006 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 IN THE INFERIOR VENA CAVA (IVC) WAS PRESENT. THE DOME WAS LOCATED JUST SUPERIOR TO THE JUNCTION OF THE RENAL VEINS WITH IVC. THE FILTER STRUTS DIFFUSELY BULGE THE IVC WALLS WITH POSTERIOR STRUT PROTRUDING 4MM POSTERIOR TO IVC WALL, ABUTTING L2 VERTEBRAL BODY. ALL REMAINING STRUTS SHOW PENETRATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Perforation

  MAUDE report 9955840 ↗
• InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6)2003 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6)2019, A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN REVEALED POSITIVE MESENTERIC PERFORATION. THERE WERE NO SIGNS OF TILTING, MIGRATION, STENOSIS, AND FRACTURE/BENDING.

  Patient problems: Perforation

  MAUDE report 9949031 ↗
• InjuryApr 10, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2012 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE FILTER WAS WELL POSITIONED WITH ITS PROXIMAL FILTER AT THE LEVEL OF THE LEFT RENAL VEIN. TWO DISTAL STRUTS FROM THE FILTER WERE EXTENDING BEYOND THE VESSEL WALL. THE COMPLICATION OF THE FILTER WAS DUE TO THE FILTER TILTING AS WELL AS ITS STRUTS PERFORATING THE VESSEL WALL.

  Patient problems: Perforation

  MAUDE report 9949007 ↗
• InjuryApr 10, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2005 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTATED TOMOGRAPHY (CT) SCAN OF ABDOMEN REVEALED THE SUPERIOR TIP OF THE FILTER WAS ANTERIORLY TILTED TO THE ABUTTING WALL OF THE INFERIOR VENA CAVA (IVC). STRUTS EXTEND BEYOND LUMEN INFERIORLY EXCEPT ONE. THESE DO NOT PENETRATE ADJACENT STRUCTURES.

  Patient problems: Perforation

  MAUDE report 9948492 ↗
• InjuryApr 10, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED A PERFORATION AND TILT OCCURRED. ON (B)(6) 2005, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED A TILT AND MESENTERIC PERFORATION. THE INFERIOR VENA CAVA (IVC) FILTER IS TILTED TO THE LEFT AND NOSE IS WITHIN THE WALL OF THE IVC AT ABOUT 1:00. THE LEGS PROTRUDE BEYOND THE WALL OF THE IVC. TWO OF THE LEGS ARE BENEATH AORTIC BIFURCATION.

  Patient problems: Perforation

  MAUDE report 9948316 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2002 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019 , A COMPUTATED TOMOGRAPHY (CT) SCAN REVEALED THAT THE FILTER HAD TILTED LATERALLY TO THE RIGHT AND THERE WAS ANTERIOR TILTING. APEX OF FILTER DOES CONTACT ANTERO-LATERAL WALL OF INFERIOR VENA CAVA (IVC) ON RIGHT. APEX IS LOCATED APPROXIMATELY 20MM DISTAL TO LEFT RENAL VEIN ORIGIN. ALL 6 STRUTS DO PROTRUDE BEYOND WALL/LUMEN OF IVC. 3 ANTERIOR STRUTS EXTEND BEYOND WALL OF IVC APPROXIMATELY BY 6MM. ANTERIOR STRUT PARTIALLY EXTENDED INTO SMALL VEIN AND REMAINDER OF STRUTS DO NOT APPEAR TO DEFINITELY INVOLVE ADJACENT ORGANS. IT WAS FURTHER REPORTED THAT THE 3 MOST POSTERIORLY POSITIONED STRUTS EXTEND BEYOND THE LUMEN OF THE IVC BY APPROXIMATELY 4 MM EACH. THE APEX OF THE IVC FILTER DOES NOT APPEAR TO PROTRUDE BEYOND THE WALL OF THE IVC. NO ABNORMAL FLUID COLLECTION IS SEEN ABOUT THE IVC.

  Patient problems: Perforation

  MAUDE report 9945883 ↗
• MalfunctionApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2005 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTATED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN AND INFERIOR VENA CAVA (IVC) FILTER REVEALED THE APEX OF THE FILTER IS AT CONFLUENCE OF RENAL VEINS AND IVC. NO SIGNIFICANT TILTING IS SEEN. STRUTS ARE INTACT. MILD EXTENSION BEYOND CONFINES OF VENA CAVA IS NOTED. ONE STRUT APPROXIMATES RIGHT WALL OF THE POSTEROLATERAL AORTA. NO PERIAORTIC DENSITY IS SEEN TO SUGGEST HEMATOMA OR OTHER ABNORMALITY.

  Patient problems: No Consequences Or Impact To Patient; Perforation

  MAUDE report 9945864 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2005, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2018, MEDICAL IMAGING SHOWED THE INFERIOR VENA CAVA (IVC) FILTER WITH CEPHALAD TIP BELOW THE RIGHT RENAL ARTERY AND AT THE LEVEL OF THE RIGHT RENAL VEIN. THERE IS TILTING OF THE IVC FILTER TOWARDS THE RIGHT. THE SIX LIMBS OF THE IVC FILTER EXTEND BEYOND THE CONFINES OF THE IVC WALL.

  Patient problems: Perforation

  MAUDE report 9945862 ↗
• InjuryApr 9, 2020Break; Positioning Problem; Break; Positioning Problem

  ON (B)(6) 2011 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTATED TOMOGRAPHY (CT) SCAN REVEALED A FRACTURED FILTER, TILT AND PERFORATION. THE PROXIMAL TIP OF THE FILTER IS LOCATED 9-10MM BELOW THE INFERIOR MARGIN OF THE RIGHT RENAL VEIN. THE PROXIMAL APEX OF THE FILTER IS TILTED ANTERIORLY. ANTERIOR MARGIN OF THE APEX OF THE FILTER ATTACHING TO THE ANTERIOR WALL OF THE INFERIOR VENA CAVA (IVC). DISTAL TIPS OF ALL THE PERIPHERAL STRUTS OF THE FILTER APPEAR TO EXTEND BEYOND THE MARGINS OF THE IVC IN THE AXIAL PLANE. RIGHT ANTEROLATERAL STRUT AT 10-11 OCLOCK APPEARS TO COURSE ALONG THE ANTERIOR IVC MARGIN FOR AT LEAST 1CM. ANTERIOR STRUT AT 12 OCLOCK ALSO APPEARS TO COURSE ANTERIOR TO THE IVC MARGIN FOR AT LEAST 1.5CM. LEFT LATERAL STRUT AT 3 OCLOCK APPEARS TO COURSE EXTRALUMINAL FOR AT LEAST 2.5CM., DISTAL TIP NOTED CLOSE TO THE RIGHT POSTEROLATERAL MARGIN OF THE AORTA, THOUGH NOT CLEARLY INVADING THE AORTA. 2 ADJACENT RIGHT POSTEROLATERAL STRUTS AT 9 OCLOCK AND 8 OCLOCK APPEAR TO BE AT LEAST PARTIALLY EXTRALUMINAL DISTALLY FOR AT LEAST 5MM. THIS STRUT APPEARS TO BE BENT SLIGHTLY POSTEROLATERALLY TOWARDS THE RIGHT, ORIGINALLY ORIGINATING AT

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 9944168 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2005, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON AN UNKNOWN DATE, COMPUTED TOMOGRAPHY (CT) SCAN REVEALED MESENTERIC PERFORATION. THERE WAS NO SIGN OF FILTER TILT, MIGRATION, FRACTURE/BENDING, STENOSIS. THE DEPTH OF PENETRATION/PERFORATION WAS NOT REPORTED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2019 THE PATIENT HAD THE CT OF THEIR ABDOMEN. THE IMAGING SHOWED THAT THERE IS A RETROAORTIC LEFT RENAL VEIN. THE TIP OF THE IVC FILTER IS PLACED AT THE ORIGIN OF THE LEFT RENAL VEIN. THE IVC FILTER IS DIRECTED STRAIGHT ALONG THE COURSE OF THE IVC. THE TIP OF THE FILTER IS ADJACENT BUT DOES NOT APPEAR TO TOUCH THE LEFT LATERAL IVC WALL. THE DISTAL PROGS OF THE IVC FILTER EXTENDS SLIGHTLY BEYOND THE IVC WALL. SUBTLE FATTY TISSUE PLANES ARE NOTED ALONG THE ANTERIOR STRUTS. THE IVC FILTER DOES NOT INVOLVE SURROUNDINGS STRUCTURES. THERE IS NO FRACTURE OF THE FILTER STRUTS. THE IVC FILTER TERMINATES BEFORE THE BIFURCATION INTO THE COMMON ILIAC VEINS.

  Patient problems: Perforation

  MAUDE report 9943903 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2009, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, MSR2_PRIME , COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THERE WAS A 2.7 DEGREE TILT TO THE LEFT. THERE WAS AN 8.4 DEGREE ANTERIOR TILT. NO STRUT FRACTURE WAS NOTED. ALL 6 OF THE STRUTS EXTEND BEYOND THE WALL OF THE IVC. THE LEFT LATERAL STRUT AT 3:00 POSITION DOES APPEAR TO EXTEND INTO THE AORTA.

  Patient problems: Perforation

  MAUDE report 9943856 ↗
• MalfunctionApr 9, 2020Migration; Migration

  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 MIGRATED IN THE SUPRARENAL PART OF INFERIOR VENA CAVA (IVC) IN THE INTRA-HEPATIC SEGMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9943543 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2003 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE FILTER TILTED 10 DEGREES TO THE RIGHT AND 26 DEGREES ANTERIORLY. THE APEX OF THE FILTER WAS TOUCHING THE ANTERIOR WALL. THE TINES PERFORATED UP TO 2MM AND ONE TINE SLIGHTLY CONTACTED THE OUTER SURFACE OF THE ADJACENT AORTA.

  Patient problems: Perforation

  MAUDE report 9943542 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 29 APRIL 2005 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN REVEALED THE SUPERIOR TIP OF INFERIOR VENA CAVA (IVC) FILTER IS LOCATED IN IVC PORTION WHICH IS WITHIN LIVER. THE SUPERIOR TIP OF THE FILTER IS 1CM INFERIOR TO THE RIGHT HEMI-DIAPHRAGM. THE FILTER WAS NOT FRACTURED. ALL STRUTS OF HAVE MIGRATED OUTSIDE OF IVC. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED PAIN.

  Patient problems: Pain; Perforation

  MAUDE report 9943538 ↗
• MalfunctionApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2013, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN AND AN INJURY REVEALED THAT THE DEVICE HAD 7 DEGREES ANTERIOR TILT. TILT OF FILTER ABUTS ANTERIOR WALL OF IVC, BUT THERE IS NO DEFINITIVE PERFORATION OF INFERIOR VENA CAVA (IVC) WALL BY ANY FILTER STRUTS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9943061 ↗