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Greenfield™ M001504000Recalls & reported problems

Boston Scientific Corporation · Vena Cava Filter · Class 2 · Implant

Quick summary

This Boston Scientific Greenfield vena cava filter is an implanted device placed in the inferior vena cava to catch blood clots. Most of the 29 adverse event reports describe the filter sitting at an angle, with its metal struts breaking through the vein wall, sometimes drifting out of position or breaking apart, along with back, flank or leg pain and swelling. There were26 injuries and no deaths. No recalls name this device, and no new reports have been filed since2022.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
29
Deaths reported
0
Injuries reported
26
Recalls naming it
0

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08714729070276), received between May 28, 2019 and Sep 21, 2022 — classified as 26 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (16 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

Device problems

  • Positioning Problem16
  • Adverse Event Without Identified Device or Use Problem9
  • Migration2
  • Break1
  • Malposition of Device1
  • Positioning Failure1

Patient problems

  • Perforation20
  • No Consequences Or Impact To Patient3
  • Perforation of Vessels2
  • Abdominal Pain1
  • Injury1
  • Pain1
  • Stenosis1
  • Swelling/ Edema1

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

  • InjurySep 21, 2022Positioning Problem; Positioning Problem

    IT WAS REPORTED THAT THE FILTER WAS TILTED AND HAD PERFORATED THE INFERIOR VENA CAVA (IVC). ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. THE PATIENT HAD A HISTORY OF DEEP VENOUS THROMBOSIS (DVT). ON (B)(6) 2019, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN TO EVALUATE THE PLACEMENT OF THE IVC FILTER. THERE WAS AN APPROXIMATE 19 DEGREE TILT TO THE RIGHT SIDE. THE FILTER STRUTS EXTENDED OUTSIDE THE CONFINES OF THE IVC, ESPECIALLY POSTERIORLY. THE MOST CENTRAL POSTERIOR STRUT EXTENDED TO THE VERTEBRAL BODY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: Perforation

    MAUDE report 15461881 ↗
  • InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE INFERIOR VENA CAVA (IVC) FILTER HAD PERFORATED THE IVC. ON (B)(6) 2001, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. ON (B)(6) 2019, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN TO ASSESS IVC FILTER PLACEMENT. MULTIPLE PRONGS OF THE DISTAL PORTION OF THE DEVICE WERE LOCATED OUTSIDE THE LUMEN OF THE IVC, AND THE PROXIMAL PORTION WAS SEEN JUST ANTERIOR TO THE IVC.

    Patient problems: Perforation

    MAUDE report 15319618 ↗
  • InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2001, THE PATIENT WAS SURGICALLY IMPLANTED WITH A GREENFIELD STAINLESS STEEL VENA CAVA FILTER. ON (B)(6) 2019, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE THE GREENFIELD FILTER DUE TO INTERMITTENT LEFT BACK/FLANK PAIN, CHRONIC SWELLING AND PAIN OF LOWER LIMB EXTREMITIES (LLE). THE PROCEDURE REQUIRED ADVANCED COMPLEX TECHNIQUES THAT PROLONGED THE PROCEDURE. A 9 FRENCH SHEATH WAS UNABLE TO DISLODGE THE FILTER, SO A 16 FRENCH LIGHT LASER SHEATH WAS USED ALONG WITH A PULSED LASER. THE FILTER AND SHEATH WERE BOTH REMOVED FROM THE PATIENT.

    Patient problems: Pain; Swelling/ Edema

    MAUDE report 11796595 ↗
  • 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) 2014. ON (B)(6) 2017 IT WAS NOTED THAT A PERFORATION HAD OCCURRED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: Perforation

    MAUDE report 11581832 ↗
  • InjuryFeb 26, 2021Malposition of Device; Malposition of Device

    IT WAS REPORTED THAT THERE WAS A PERORATION AND THE FILTER WAS TILTED. A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2005. ON AN UNKNOWN DATE IT WAS NOTED THAT A PERFORATION HAD OCCURRED. IT WAS ALSO NOTED THAT THE FILTER WAS TILTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: Perforation

    MAUDE report 11385408 ↗
  • InjuryFeb 26, 2021Break; Break

    A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2001. ON (B)(6) 2017 IT WAS NOTED THAT THERE IS A GREENFIELD FILTER IN POSITION IN THE INFRARENAL SEGMENT OF THE IVC. THERE IS INTERVAL FRACTURE OF AN ANTERIOR STRUT AND THE STRUT PROJECTS LATERALLY AND EXTENDS BEYOND THE CONTOUR OF THE IVC. ANOTHER MEDIAL STRUT EXTENDS MORE THAN 3MM BEYOND THE WALL OFT THE IVC. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: Perforation

    MAUDE report 11385394 ↗
  • InjuryApr 13, 2020Positioning Problem; Positioning Problem

    ON (B)(6) 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 APEX OF THE FILTER SITS ADJACENT TO ANTERIOR WALL OF INFERIOR VENA CAVA (IVC) AT THE LEVEL OF THE RIGHT RENAL VEIN. PERFORATION OF THE WALL MANIFESTS AS A FLAT PLANE BETWEEN IVC WALL. THE DISTAL END OF THE FILTER COMPONENT IS PRESENT AT POSTERIOR RIGHT LATERAL ASPECT. THE REMAINING STRUTS SIT RIGHT AT IVC WALL WITHOUT CLEAR PERFORATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Patient problems: Perforation

    MAUDE report 9955866 ↗
  • MalfunctionApr 10, 2020Positioning Problem; Positioning Problem

    ON (B)(6) 2014 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON A UNKNOWN DATE, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A POSITIVE TILT. THE FILTER WAS POSTERIORLY TILTED AND THE APEX ABUTTED THE POSTERIOR WALL OF THE INFERIOR VENA CAVA. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A CT OF THEIR ABDOMEN ON (B)(6) 2018.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9949162 ↗
  • InjuryApr 8, 2020Positioning Problem; Migration; Positioning Problem; Migration

    ON (B)(6) 2009 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2018 A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN REVEALED A SLIGHT TILTING OF THE FILTER TO THE RIGHT AND POSTERIORLY BUT WITHOUT THE APEX CONTACTING THE INFERIOR VENA CAVA (IVC) WALL. THERE WAS A SLIGHT CAUDAL MIGRATION OF THE FILTER WITH THE APEX 2.6CM CAUDAL TO THE LOWEST RENAL VEIN. A FILTER STRUT HAD PERFORATED THE IVC WALL UP TO 2MM BUT WITHOUT ADJACENT ORGAN PENETRATION. THE LEFT LATERAL STRUT WAS IN CONTACT WITH THE AORTA WALL.

    Patient problems: Perforation

    MAUDE report 9940470 ↗
  • InjuryApr 8, 2020Positioning Problem; Positioning Problem

    IN (B)(6) 2005 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. IN (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A 9 DEGREE TILT AND 4 OF 6 STRUTS PENETRATE THE VENA CAVA WALL 3 TO 5 MM.

    Patient problems: Perforation

    MAUDE report 9939123 ↗
  • MalfunctionApr 8, 2020Positioning Problem; Positioning Problem

    IN (B)(6) 2003 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. IN (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN REVEALED THE PROXIMAL TIP OF THE FILTER WAS 6CM FROM LEFT RENAL VEIN. THERE WAS NORMAL ALIGNMENT ALONG AXIS. IT WAS FURTHER REPORTED THAT THE STRUTS APPEARED NORMALLY ORIENTED WITH NO PERFORATION OF THE VENA CAVA OR SURROUNDING HOLLOW OR SOLID ORGANS AND NO RETROPERITONEAL MASS OR FLUID COLLECTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9939107 ↗
  • InjuryApr 8, 2020Positioning Problem; Positioning Problem

    ON (B)(6) 2004 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2020 A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN/PELVIS REVEALED THE FILTER SITTING CROOKED IN THE INFERIOR VENA CAVA WITH THE APEX RESTING AGAINST THE RIGHT LATERAL WALL. THE STRUTS OF THE FILTER PERFORATED THE LUMEN OF THE INFERIOR VENA CAVA. THERE WAS NO INVOLVEMENT OF THE ADJACENT AORTA OR DUODENUM.

    Patient problems: Perforation

    MAUDE report 9939022 ↗
  • InjuryApr 8, 2020Positioning Failure; Positioning Failure

    IN (B)(6)1998 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. IN (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE FILTER APPEARED TO BE IN A SATISFACTORY POSITION, HOWEVER THERE WAS AN ADDITIONAL FILTER WHICH DID NOT DEPLOY; IDENTIFIED WITHIN THE RIGHT ILIAC VEIN.

    Patient problems: Injury

    MAUDE report 9938839 ↗
  • InjuryApr 8, 2020Positioning Problem; Positioning Problem

    IT WAS REPORTED THAT DEVICE TILTING AND A PATIENT PERFORATION OCCURRED. IN (B)(6) 2012, A GREENFIELD FILTER WAS IMPLANTED IN A PATIENT IN (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) REVEALED THE APEX OF FILTER LIED WITHIN 5MM OF THE CONFLUENCE OF THE RIGHT RENAL VEIN. THERE WAS POSTERIOR TILT OF APEX. THERE WAS ALSO A BORDERLINE STRUT PERFORATION ALONG 2 POSTERIOR STRUTS AND MEDIAL STRUT. THE MEDIAL STRUT CONTACTS SURFACE OF AORTA.

    Patient problems: Perforation

    MAUDE report 9938837 ↗
  • InjuryApr 8, 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 THE FILTER WAS TILTED GREATER THAN 15 DEGREES. THE TIP OF THE FILTER WAS PROJECTING THE LATERAL RIGHT MARGIN OF THE IVC. ALL STRUTS PENETRATE THE MARGIN OF THE IVC AND ABUT THE POSTERIOR WALL OF THE SMALL BOWEL. A STRUT IS IN CLOSE PROXIMITY TO THE WALL OF THE AORTA. THE STRUT ABUTS THE PREVERTEBRAL SOFT TISSUES AND CORTEX OF THE L4 VERTEBRAL BODY. ANOTHER STRUT PENETRATES THE PSOAS MUSCLE, AND ANOTHER STRUT ABUTS A SMALL VEIN.

    Patient problems: Perforation

    MAUDE report 9938754 ↗
  • InjuryApr 8, 2020Positioning Problem; Positioning Problem

    ON (B)(6) 2008 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE IVC FILTER IS TILTED FIVE DEGREES RIGHTWARD. THE APEX OF THE IVC FILTER DOES NOT TOUCH THE IVC WALL. THE FILTER APEX IS LESS THAN 2CM BELOW THE MOST INFERIOR RENAL VEIN. THE DISTAL IVC FILTER STRUTS UNIFORMLY MINIMALLY PERFORATE THE WALL. THERE ARE NO FRACTURED OR BENT STRUTS, NO SIGNIFICANT INFERIOR VENA CAVA STENOSIS WAS IDENTIFIED", AND NO MIGRATION.

    Patient problems: Perforation

    MAUDE report 9938460 ↗
  • InjuryApr 8, 2020Positioning Problem; Positioning Problem

    ON (B)(6) 2004 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2018 A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED MESENTERIC PERFORATION AND TILT. THE TIP WAS POSTERIORLY TILTED RIGHT POSTERIOR LATERAL LIMB WITHOUT ABUTTING THE LATERAL WALL. ALL STRUTS APPEARED EXTRALUMINAL WITHOUT ERODING THE ADJACENT ORGANS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Patient problems: Perforation

    MAUDE report 9935395 ↗
  • InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PERFORATION OCCURRED. COMPUTED TOMOGRAPHY SCAN OF THE ABDOMEN REVEALED POSITIVE FOR PERFORATION. THE FILTER TINES EXTENDED BEYOND THE MURAL MARGINS OF INFERIOR VENA CAVA. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT GREENFIELD FILTER PLACEMENT ON (B)(6) 2007. THE PATIENT HAD A CT SCAN OF THEIR ABDOMEN ON (B)(6) 2018.

    Patient problems: Perforation

    MAUDE report 9934891 ↗
  • InjuryMar 16, 2020Positioning Problem; Positioning Problem

    A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2011. ON AN UNKNOWN DATE IT WAS NOTED THERE WAS A PERFORATION. THE FILTER WAS NOTED TO BE TILTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE GREENFIELD VENA CAVA FILTER WAS PLACED AS PRECAUTION AS THE PATIENT HAD POSITIVE LEFT POSTERIOR TIBIAL VEIN THROMBOSIS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. THE PATIENT WAS DISCHARGED HOME AFTER ARRANGEMENTS FOR OUTPATIENT IV ANTIBIOTICS WERE MADE. ON (B)(6) 2017, A CT SCAN OF THE ABDOMEN WAS PERFORMED. THE EXAMINATION FINDINGS REVEALED THE IVC FILTER INSERTION WITH 10 DEGREES RIGHT LATERAL TILT OF THE FILTER. THE FILTER TIP TOUCHES THE RIGHT LATERAL CAVAL WALL JUST BELOW THE RIGHT RENAL VEIN ORIGIN. THREE IVC STRUTS NOTED AT 1 O'CLOCK, 4 O'CLOCK AND 5 O'CLOCK EXTEND 0.3 CM THROUGH THE CAVAL WALL. THERE IS NO PARA-AORTIC OR PARACAVAL ADENOPATHY. THE IVC FILTER WAS AT A 10 DEGREE RIGHT LATERAL TILT AND 3MM PERFORATION OF THREE FILTER STRUTS THROUGH THE LEFT LATERAL CAVAL WALL.

    Patient problems: Perforation

    MAUDE report 9837358 ↗
  • InjuryMar 16, 2020Positioning Problem; Positioning Problem

    A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2015. ON AN UNKNOWN DATE IT WAS NOTED THERE WAS A PERFORATION. THE FILTER WAS NOTED TO BE TILTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2017 THE PATIENT HAD A CT OF THEIR ABDOMEN. THE IMAGING REVEALED THAT THE ABDOMINAL VASCULATURE DEMONSTRATES AN IVC FILTER IN PLACE WITH THE TIP AT THE LEVEL OF THE RENAL VEINS. THE IVC FILTER IS TILTED ANTERIORLY WITH THE APEX ABUTTING THE ANTERIOR WALL OF THE INFERIOR VENA CAVA. A POSTERIOR STRUT PENETRATES THE POSTERIOR WALL OF THE INFERIOR VENA CAVA AND IS EMBEDDED IN THE ANTERIOR ASPECT OF THE L3 VERTEBRAL BODY. THIS EXTENDS APPROXIMATELY 8 MM POSTERIOR TO THE POSTERIOR WALL OF THE INTERIOR VENA CAVA. NO STRUT FRACTURE IS NOTED.

    Patient problems: Perforation

    MAUDE report 9837356 ↗
  • InjuryMar 16, 2020Positioning Problem; Positioning Problem

    A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2006. ON(B)(6) 2017, IT WAS NOTED THERE WAS A PERFORATION. THE FILTER WAS NOTED TO BE TILTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT PRESENT WITH A PULMONARY EMBOLISM, INABILITY TO ANTICOAGULATED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT INTERNAL JUGULAR VEIN, WHERE A GUIDEWIRE WAS ALSO PASSED. A 10FR SHEATH WAS PLACED OVER THE WIRE AND THE WIRE WAS REMOVED AND EXCHANGED FOR A 0.035 GUIDEWIRE. THE GREENFIELD FILTER WAS ADVANCED THROUGH THE DILATOR AND THROUGH THE RIGHT ATRIUM INTO THE IVC INFRARENAL POSITION. A 12.5 FR DILATOR WIRE WAS PLACED OVER THE WIRE, FOLLOWED BY THE DILATOR AND SHEATH FROM THE DELIVERY SYSTEM. THE SHEATH WAS PLACED AT THE L1 VERTEBRAL BODY, THE DILATOR WAS REMOVED. THE IVC WAS MEASURED AT 15MM IN DIAMETER. AT THIS POINT THE DILATOR AND WIRE WAS PLACED THROUGH THE SHEATH, THE SHEATH WAS THEN ADVANCED, AND THE DILATOR WAS REMOVED OVER THE WIRE. THE GREENFIELD FILTER AND ITS DELIVERY SYSTEM WERE THEN PLACED AND POSITIONED OVER THE L2-3 VERTEBRAL BODIES. THE SHEATH WAS THEN PULLED BACK AND THE FILTER WAS DEPLOYED WITHOUT DIFFICULTY. THERE WAS MINIMAL TILT OVER THE WIR

    Patient problems: Perforation

    MAUDE report 9834549 ↗
  • InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2008. ON AN UNKNOWN DATE IT WAS NOTED THAT PERFORATION HAD OCCURRED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2017 THE PATIENT WAS SEEN TO ASSESS THE IVC FILTER POSITION. THE PATIENT RECEIVED A CT OF THE ABDOMEN WITHOUT CONTRAST. FINDINGS REVEALED THAT THE IVC FILTER TIP APPEARS POSITIONED AT THE POSTERIOR WALL. THE TIP OF THE FILTER APPEARS EMBEDDED AT THE POSTERIOR WALL WHICH WILL LIKELY MAKE RETRIEVAL MORE DIFFICULT. THE LEGS OF THE FILTER APPEAR TO EXTEND JUST BEYOND THE WALL NC 2 MM INTO THE RETROPERITONEAL FAT WITHOUT EXTENSION INTO ANY OF THE SURROUNDING STRUCTURES. NO SIGNIFICANT FILTER TILT IDENTIFIED. THE FILTER APPEARS TO BE POSITIONED SUCH THAT IT WILL FUNCTION APPROPRIATELY. FILTER IS IN APPROPRIATE POSITION IMMEDIATELY BELOW THE RENAL VEINS. NO INFERIOR VENA CAVA STENOSIS. NO FILTER FRACTURE OR BEND STRUT.

    Patient problems: Perforation

    MAUDE report 9829625 ↗
  • InjuryMar 13, 2020Positioning Problem; Positioning Problem

    A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2007. ON AN UNKNOWN DATE IT WAS NOTED THAT PERFORATION AND TILT OCCURRED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE GREENFIELD FILTER DEPLOYED WITHOUT DIFFICULTY. ON (B)(6) 2017 THE PATIENT RECEIVED A CT OF THE ABDOMEN WITHOUT CONTRAST FOR AN UNSPECIFIED INJURY OF THE INFERIOR VENA CAVA. FINDINGS REVEALED THE FILTER WAS AT THE LEVEL OF INFERIOR ENDPLATE OF 13 VERTEBRAL BODY. THERE IS ANTERIOR TILTING OF THE DOME NOTED. THE AORTA DEMONSTRATES SEVERE ATHEROSCLEROTIC CALCIFICATION AND ECTASIA. NO ABDOMINAL AORTIC ANEURYSM. THERE IS A RETROAORTIC RENAL VEIN PRESENTS ON THE LEFT. THE PILLARS OF THE IVC FILTER JUST ABOVE THE LEVEL OF THE LOWEST RENAL VEIN. NO ABNORMAL FRAGMENTATION OR BENDING OF THE STRUTS IS SUGGESTED. THE TIP OF THE STRUTS AS SEEN IN THE AXIAL VIEWS APPEAR TO BE ON EXTEND IVC WALL. HOWEVER, IT IS UNCLEAR WHETHER THIS REPRESENTS VOLUME AVERAGING. THERE ARE NO SURROUNDING FLUID OR INFLAMMATION SEEN. NO ACUTE FINDINGS OF THE ABDOMEN. INFERIOR VENA CAVA AND PARTICULAR APPEARS WITHOUT DISTENTION OR ANATOMIC ABNORMALITIES. IVC FILTER IN PLACE, WITH THE DOME OF THE FILTER TILTING ANTERIORLY APP

    Patient problems: Perforation

    MAUDE report 9828534 ↗
  • MalfunctionMar 12, 2020Positioning Problem; Positioning Problem

    A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2005. ON AN UNKNOWN DATE IT WAS NOTED THAT THE FILTER WAS TILTED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9825888 ↗
  • InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    MEDWATCH NUMBER MW5090798. IT WAS REPORTED THAT PATIENT EXPERIENCED ABDOMINAL PAIN. ON (B)(6) 2011, PATIENT WAS IMPLANTED WITH A GREENFIELD VENA CAVA FILTER (GVCF). PER PATIENT, SHE EXPERIENCED SEVERE ABDOMINAL PAIN 3 YEARS POST DEVICE IMPLANTATION. THEN 1 YEAR LATER, PATIENT DEVELOPED GASTROINTESTINAL BLEEDING FOR WHICH SHE WAS DIAGNOSED WITH DIVERTICULITIS. ABOUT SIX MONTHS AGO, THE PATIENT WAS DIAGNOSED WITH ACID REFLUX. THE DIAGNOSIS CAME AFTER EXPERIENCING A FEELING OF LIGHT HEADEDNESS EACH TIME SHE WENT TO THE BATHROOM TO HAVE A BOWEL MOVEMENT. THE PATIENT IS CURRENTLY ON PRILOSEC WHICH SEEMS TO BE HELPING WITH THE FEELING OF DISCOMFORT AND LIGHT HEADEDNESS.

    Patient problems: Abdominal Pain

    MAUDE report 9430998 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.