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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 Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
Event Date 06/04/2018
Event Type  Injury  
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. The medical records included images. The image review was documented in the medical records. Medical records were provided and reviewed. Approximately seven years and eleven months post filter deployment, computed tomography (ct) revealed that the filter tip was at the level of the right renal vein. There was rightward tilt of approximately 9 degrees, but several of the struts do extend peripheral to the inferior vena cava wall. A medial strut abuts the lateral wall of the aorta and laid approximately 8 mm external to the inferior vena cava wall. There are two other medial stress more superiorly, each approximately 7 mm peripheral to the inferior vena cava wall. There are two anterior struts which extend just peripheral to the inferior vena cava wall and about the peripheral wall of the duodenum. The patient also experienced significant pain due to the filter. Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc). However, the investigation is unconfirmed for the filter tilt as the medical states, ¿there was rightward tilt of approximately 9 degrees. "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.
 
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. At some time post filter deployment, it was alleged that the filter tilted and struts perforated. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient experienced pain due to filter; however, the current status of the patient is unknown.
 
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Brand NameECLIPSE FILTER SYSTEM - FEMORAL
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 Key11364175
MDR Text Key233077171
Report Number2020394-2021-80187
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 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEC500F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2021
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: 02/23/2021 Patient Sequence Number: 1
Treatment
COUMADIN
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