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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 Problems Patient-Device Incompatibility (2682); Extrusion (2934)
Patient Problems No Consequences Or Impact To Patient (2199); Thrombosis/Thrombus (4440)
Event Date 04/06/2018
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged filter perforation as no objective evidence has been provided to confirm any alleged deficiency with the filter.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.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 through the litigation process that approximately five years five months post filter deployment a ct scan demonstrated the filter perforated and embedded.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.
 
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.Approximately five years and five months post filter deployment, a computed tomography scan demonstrated that the filter struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: b5, b6, b7, d4 (expiry date: 04/2015).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.
 
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.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately, two years five months of post deployment, venogram revealed in the inferior vena cava there was a significant degree of thrombosis with minimum flow in the lateral aspect and also clots within the cone of the filter and clot extended above the filter.The patient underwent mechanical thrombectomy with the angiojet device and balloon angioplasty.Around, two years and eleven months later, computed tomography of the abdomen without contrast revealed the filter head was located approximately 2.3 cm below the level of the lowest left renal vein.A total of six distal prongs are identified coursing through the inferior vena cava wall consistent with perforation.Posterior prong was identified coursing toward the right upper vertebral body endplate of l3 vertebra with 5 mm course into the vertebral body.The inferior vena cava was contracted at the level of the filter and below the filter down to the confluence.The prongs are visualized perforated through the inferior vena cava by up to 2 cm for the longest most distal six prongs.Perforation appears shorter on the axial image, measures in anterolateral to the left prong perforation approximately 8 mm.Posterior lateral right perforation was approximately 8 mm.The long axis of the filter was parallel to the inferior vena cava.No filter fracture or displacement was appreciated.Therefore, the investigation is confirmed for the perforation of the inferior vena cava.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.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: 04/2015.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.Approximately five years and five months post filter deployment, a computed tomography scan demonstrated that the filter struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.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 Key7555515
MDR Text Key109629283
Report Number2020394-2018-00760
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,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEC500F
Device Lot NumberGFWC3995
Was Device Available for Evaluation? No
Date Manufacturer Received05/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age53 YR
Patient Weight77
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