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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL; VENA CAVA FILTER Back to Search Results
Catalog Number EC500F
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 12/07/2010
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis, pulmonary embolism and right heart strain.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with thrombosis up to the level of the inferior vena cava filter; however, the current status of the patient is unknown.
 
Manufacturer Narrative
Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, five months twelve days of post deployment, the patient presented with abdominal and flank pains.On the same day, a computed tomography (ct) kidney demonstrated that an inferior vena cava filter was noted incidentally.After, four days, an ultrasound right lower extremity venous doppler showed that there was extensive bilateral deep vein thrombosis, that extended from the common femoral vein to the popliteal veins bilaterally.After, five days, the patient was diagnosed with thrombosis of the inferior vena cava filter, up to the level of the inferior vena cava filter and also had thrombosis of the femoral and popliteal veins bilaterally.After, one month and twenty-four days, a computed tomography (ct) abdomen and pelvis with intravenous contrast showed there was an infrarenal inferior vena cava filter.There was extensive thrombosis of the inferior vena cava inferior to the filter, that extended into the common iliac, internal iliac, external iliac, and visualized common femoral veins bilaterally.After, three weeks and two days, a computed tomography (ct) chest with intravenous contrast showed that there was thickening seen along the wall of the distal right pulmonary artery, that extended into the segmental branches, likely represented sequelae of prior pulmonary arterial thrombus.No acute convincing pulmonary arterial embolus was identified at this time.Similar changes were seen within the segmental branches, that supply the left lower lobe.Also, an ultrasound right lower extremity venous doppler showed that there was complete occlusion of the lower extremity veins on the right including the common femoral, and popliteal veins.After, five months and seventeen days, a computed tomography angiography (cta) chest showed that there was no central large pulmonary embolism.Also, the patient was diagnosed with inferior vena cava thrombosis up to the level of the filter with bilateral chronic and acute deep venous thrombosis.After, two weeks and five days, a computed tomography (ct) abdomen without intravenous contrast showed that an inferior vena cava filter was in appropriate position within the immediate infrarenal inferior vena cava.There were no signs of strut fracture and perforation.A hypoplastic inferior vena cava consistent with inferior vena cava thrombosis was noted, below the renal veins.There was no sign of abnormal tilt of the inferior vena cava filter.There were no device deficiencies identified within the medical records.Therefore, the investigation is inconclusive for as no objective evidence has been provided to confirm any alleged deficiency with the filter.Additionally, it can be confirmed that the patient experienced thrombus upto the level of the filter post deployment.However, the relationship to the filter is unknown.Based on 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.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 after being diagnosed with deep vein thrombosis, pulmonary embolism and right heart strain.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with thrombosis up to the level of the inferior vena cava filter; however, the current status of the patient is unknown.
 
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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
MDR Report Key11692580
MDR Text Key246227854
Report Number2020394-2021-80332
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K093659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEC500F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/24/2021
Initial Date FDA Received04/20/2021
Supplement Dates Manufacturer Received05/05/2021
Supplement Dates FDA Received05/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COUMADIN, PERCOCET, ARIXTRA AND CIPROFLOXACIN; COUMADIN, PERCOCET, ARIXTRA AND CIPROFLOXACIN; ERGOCALCIFEROL AND HYDROXYZINE PAMOATE; ERGOCALCIFEROL AND HYDROXYZINE PAMOATE; SIMVASTATIN AND TRAMADOL HYDROCHLORIDE; SIMVASTATIN AND TRAMADOL HYDROCHLORIDE; COUMADIN, PERCOCET, ARIXTRA AND CIPROFLOXACIN; ERGOCALCIFEROL AND HYDROXYZINE PAMOATE; SIMVASTATIN AND TRAMADOL HYDROCHLORIDE
Patient Outcome(s) Other;
Patient Age42 YR
Patient Weight94
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