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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 Difficult to Remove (1528); Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Death (1802)
Event Date 09/27/2010
Event Type  Death  
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. Medical records were provided and reviewed. Approximately one month later, patient experienced abdominal pain. Subsequent, ct revealed two of the ivc filter arms have traversed the ivc and the filter was found to be tilted in the ivc. Two or three legs of the filter were extra luminal. The tip of the filter was up against the wall of the vena cava. The attempts to grab the filter using sheath and snare were unsuccessful as the filter was up against the wall. Next a biplane and snare device was used to grasp the tip. This was also unsuccessful as this could not be placed around the tip. Eventually, the filter was pulled out in its entirety using french cobra shaped sheath. Therefore, the investigation is confirmed for perforation of the ivc, filter tilt and retrieval difficulties. Per medical records, multiple attempts were made to engage the filter using snare and sheath but were unsuccessful due to filter tilt. This could have contributed to the retrieval difficulties. However, 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: 06/2013).
 
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 embedded in the wall of ivc and struts perforated. The device was removed percutaneously. The patient reportedly expired.
 
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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 Key9486238
MDR Text Key171775115
Report Number2020394-2019-05674
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 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEC500F
Device Lot NumberGFUD2533
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2010
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: 12/18/2019 Patient Sequence Number: 1
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