MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number EC500F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Extrusion (2934)

Patient Problems Abdominal Pain (1685); Pain (1994); Vomiting (2144); Great Vessel Perforation (2152)

Event Date 12/03/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: the patient with history of head trauma was scheduled for vena cava filter placement.The right common femoral vein was accessed and a flush catheter was advanced.A cavagram was performed which identified the renal veins and demonstrated no filling defects within the inferior vena cava.A filter was deployed below the renal veins.The sheath was removed and manual compression was held on the right groin until hemostasis was achieved.Approximately two years six months post filter deployment, the patient presented to the emergency department with complaint of vomiting, back pain and abdominal pain.Ct scan of the abdomen and pelvis demonstrated a tilted filter with several limbs extending beyond the caval wall into the surrounding soft tissue.A detached filter limb was identified in the right psoas muscle.It was thought that the filter perforation could be the cause of back pain and abdominal pain.A follow up ct scan with contrast was recommended to assess for perforation of any vascular structures.The patient was discharged from the hospital in stable condition and was contacted to schedule elective removal of the vena cava filter.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Approximately two years six months post filter deployment, ct scan of the abdomen and pelvis demonstrated a tilted filter with several limbs extending beyond the caval wall into the surrounding soft tissue.A detached filter limb was identified in the right psoas muscle.Based on the provided medical records, the investigation is confirmed for a tilted filter, perforation of the ivc wall, and a detached filter limb.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: - filter fractures are a known complication of vena cava filters.- movement, migration or tilt of the filter are known complications of vena cava filters.- perforation or other acute or chronic damage of the ivc wall.- filter tilt.- filter malposition.Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.(b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that a vena cava filter was deployed successfully, the reason for the filter deployment was not provided.No alleged deficiency with the device was reported.No other information regarding this event was received.Patient status was not provided.New information received: medical records were received and reviewed.The patient with history of head trauma had a vena cava filter successfully deployed.Approximately two years six months post filter deployment, the patient presented to the emergency department with complaint of vomiting, back pain and abdominal pain.Ct scan demonstrated a tilted filter with multiple limbs extending beyond the caval wall into surrounding soft tissue and a detached filter limb in the right psoas muscle.The patient was discharged in stable condition and was advised to schedule elective removal of the vena cava filter.No additional information was provided in the medical records received.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately two years and five months later, a computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that inferior vena cava filter was noted.The filter was markedly tilted to the right and many of the legs have penetrated the caval wall.At least two of the legs have penetrated into the aorta and one was fractured in the right psoas muscle.After two weeks, a computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that inferior vena cava filter was noted.After six days, a computed tomography of abdomen and pelvis was performed which showed malpositioned inferior vena cava filter with significant caval penetration of the legs.One of the legs appears to be fractured in the right psoas muscle.After three days, a computed tomography of abdomen and pelvis was performed for abdominal pain and back pain.The study showed that inferior vena cava filter was noted with its apex tilted towards the right side of the wall of the inferior vena cava.Several struts have penetrated through the inferior vena cava into the surrounding soft tissues.In addition, there appears fracture fragment in the right psoas muscle.After two months, an inferior vena cavogram was performed which showed filter was tilted and its position was non-capturable.Several prongs of the inferior vena cava filter could be possibly extra-vena caval.After one year and three months, diagnostic aortogram was performed for filter evaluation.The study showed that inferior vena cava filter tines possibly across the right external iliac artery at aortic bifurcation.After one month, patient was planned for filter retrieval procedure.Through the right jugular vein approach, a glidewire was passed through the right atrium into the inferior vena cava.A digital subtraction venography was performed which showed filter was laterally displaced and appeared that the hook and apical segment were outside the inferior vena cava and therefore not retrievable and open surgery was likely to be needed.After five months, patient was planned for open retrieval of inferior vena cava filter.Midline incision was performed and exposing the inferior vena cava and aorta.The filter was obvious, and several legs were protruding through the wall of the inferior vena cava into the retroperitoneum and wall of iliac artery.Through venotomy, the tines and main body of the filter were meticulously removed in their entirety.Several tines were cut with wire cutters.Following complete retrieval, the inferior vena cava was closed.Therefore, the investigation is confirmed for the alleged filter limb detachment, filter tilt, perforation of the inferior vena cava and retrieval difficulties.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: (expiry date: 03/015) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.Approximately two years and six months post filter deployment, the patient presented to the emergency department with complaint of vomiting, back pain and abdominal pain.A computed tomography scan demonstrated a tilted filter with multiple limbs extending beyond the caval wall into surrounding soft tissue and a detached filter limb in the right psoas muscle.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

• Brand Name: ECLIPSE FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6504475
• MDR Text Key: 73220827
• Report Number: 2020394-2017-00347
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: EC500F
• Device Lot Number: GFWC1091
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DIPHENHYDRAMINE AND FLUCONAZOLE; HYDROXYZINE, LEVETIRACETAM AND LITHIUM CARBONATE; METHYLPHENIDATE, MONO-LINYAH AND NAPROXEN; ONDANSETRON AND PREDNISONE; QUETIAPINE, XANAX, ALPRAZOLAM AND AMOXICILLIN
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White