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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - JUGULAR VENA CAVA FILTER Back to Search Results
Catalog Number EC500J
Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)
Patient Problems Abdominal Pain (1685); Chest Pain (1776)
Event Date 05/12/2014
Event Type  Injury  
Manufacturer Narrative
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. The medical records allege bard eclipse inferior vena cava filter was deployed in suprarenal under fluoroscopic guidance, had good apposition to the wall and a complete vena cavogram demonstrated patent suprarenal inferior vena cava. Approximately two months of post deployment, a computed tomography of abdomen and pelvis was performed for duodenal leak. The study showed that inferior vena cava filter remains in place. Six days later a computed tomography of abdomen and pelvis was performed for abdominal fluid collection. The study showed that inferior vena cava filter was in place, which continues to appear superiorly displaced within the distal subdiaphragmatic inferior vena cava. One day later, an x-ray abdomen was performed which showed inferior vena cava filter was noted. Four days later, an x-ray chest was performed which showed inferior vena cava filter was noted within the proximal inferior vena cava. Approximately one month later, a computed tomography of chest, abdomen and pelvis was performed which showed that inferior vena cava filter was noted. Twelve days later, a computed tomography of abdomen and pelvis was performed which showed suprarenal caval filter in unchanged position with legs external to caval wall. Two days later, a computed tomography angiography of abdomen and pelvis was performed to evaluate the aortic graft infection. The study showed that suprarenal inferior vena cava filter was noted in unchanged position with legs external to the caval walls. Three days later, an x-ray chest was performed which showed slightly lower lung volumes and partially visualized upper portion of inferior vena cava filter. Six days later, an x-ray abdomen was performed which showed inferior vena cava filter was noted at the level of l1. Three days later, an x-ray chest was performed for respiratory insufficiency. The study showed that mild prominence of central pulmonary vasculature. Inferior vena cava filter was noted. Approximately eight months later, patient presented to the emergency department with the complaints of abdominal pain and right sided back pain and left lower extremity pain. Patient was treated with pain medications and discharged. Approximately six months later, patient presented to the emergency department with the complaints of abdominal and back pain. One day later, a computed tomography of abdomen and pelvis was performed for back pain. The study showed that no definite acute abnormalities within the abdomen or pelvis. Inferior vena cava filter was in unchanged position just above the left renal vein. Approximately five months later, patient presented to the emergency department with the complaints of chest pain, groin pain and black tarry stools in colostomy bag. A computed tomography of chest, abdomen and pelvis was performed for chest pain. The study showed that linear metallic density in the inferior wall of the right ventricle which was not seen on comparison examination. This was indeterminate etiology but could conceivably contribute to chest pain. The inferior vena cava filter was again seen on the hepatic and subhepatic inferior vena cava and there was a filling defect within the central portion of the inferior vena cava at the level vascular. The inferior vena cava was obliquely oriented relative to the direction of the vein, similar to prior examination. The feet of the inferior vena cava filter basket appear to extend through the vessel wall. No contrast was seen in the inferior vena cava inferior to the filter. An x-ray abdomen was performed for abdominal pain which showed post-surgical changes and inferior vena cava filter was noted. Approximately five months later, patient presented to the emergency department with the complaints of right leg pain and right foot numbness. A computed tomography of abdomen and iliofemoral study was performed for possible thrombosed graft. The study showed that complete occlusion of the entire visualized portion of the right axillofemoral bypass graft and complete occlusion of the infrarenal abdominal aorta. Complete occlusion of the right popliteal artery from its origin and right anterior tibial artery. Inferior vena cava filter was noted. Approximately four months later, patient presented to the emergency department with the complaints of groin pain. A computed tomography of abdomen and pelvis was performed for left groin pain and concern for pseudoaneurysm. The study showed that the lower chest re-demonstrated a linear metallic density at the base of the heart, which was similar appearance to prior examination. An inferior vena cava filter was present, and the medial limb was noted extending through the inferior vena cava wall grazing the superior margin of the celiac artery. A computed tomography of lower extremity was performed which showed left groin abscess abutting the junction of the patent femoral-femoral bypass graft and superficial femoral artery. No evidence of pseudoaneurysm was noted. Approximately two months later, patient presented to the emergency department with the complaints of lower back pain, abdominal pain and blood in colostomy bag. An x-ray abdomen was performed which showed presence of inferior vena cava filter. An x-ray chest was performed for nausea and vomiting which showed thin metallic density measuring up to 18 mm overlying cardiac shadow likely external. A computed tomography of abdomen and pelvis was performed for abdominal pain. The study showed that occlusion of infrarenal abdominal aorta with reconstitution of iliac vessels at the bifurcation of the internal and external iliac arteries. There was an active gastrointestinal bleed within the stomach with contrast material layering within the gastric lumen on delayed imaging. One day later, an x-ray chest was performed which showed partially visualized inferior vena cava filter. One day later, a computed tomography of thorax was performed which showed metallic foreign body located in the region of the right ventricle likely representing a fractured inferior vena cava filter leg. The inferior vena cava filter which appeared to have migrated distally to the renal veins. Four days later, patient presented to the emergency department with the complaints of right lower quadrant abdominal pain. A computed tomography of abdomen and pelvis was performed which showed occlusion of the infrarenal abdominal aorta. The inferior vena cava filter was unchanged. Approximately one month later, patient presented to the emergency department with the complaints of abdominal pain. An x-ray abdomen was performed which showed redemonstrated curvilinear foreign body located in the region of the right ventricle, likely representing a fractured inferior vena cava filter leg as demonstrated on computed tomography of chest two months ago. Abnormal location of the inferior vena cava filter which remains cephalad to the renal veins the position has not changed significantly. A computed tomography of abdomen and pelvis was performed for abdominal pain. The study showed that redemonstrated foreign body likely fractured limb of inferior vena cava filter in right ventricle. Abnormal suprarenal positioning of the inferior vena cava filter with limbs extending outside confines of inferior vena cava. Four days later, a computed tomography of thorax was performed for pulmonary embolism protocol. The study showed that persistent metallic foreign body in the right ventricle, likely fractured limb of inferior vena cava filter in right ventricle. Abnormal suprarenal positioning of inferior vena cava with limbs extending outside confines of inferior vena cava again noted without significant interval change. Therefore, the investigation is confirmed for perforation of the inferior vena cava , filter limb detachment and filter tilt. However, the investigation is inconclusive for filter migration since the medical records state that "the inferior vena cava filter which appeared to have migrated distally to the renal veins". 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. (expiry date: 05/2015).
 
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. At some time post filter deployment, it was alleged that the filter tilted, migrated to heart, struts detached and perforated. The device has not been removed and there were no reported attempts made to retrieve the filter. The detached strut retained in right ventricle. The patient experienced severe pain in chest and abdomen; however, the current status of the patient is unknown.
 
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Brand NameECLIPSE FILTER SYSTEM - JUGULAR
Type of DeviceVENA 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 Key11875265
MDR Text Key252365067
Report Number2020394-2021-80465
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEC500J
Device Lot NumberGFWD2828
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/25/2021 Patient Sequence Number: 1
Treatment
ACETAMINOPHEN, CYCLOBENZAPRINE AND GABAPENTIN; OXYCODONE, PANTOPRAZOLE, PROPRANOLOL AND WARFARIN
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