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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number UNK ECLIPSE
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 04/18/2013
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: the 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. Subsequently later post filter deployment, computed tomography revealed infrarenal inferior vena cava with the top of the filter tilted and moved into the right renal vein. Approximately one year five months later computed tomography revealed the inferior vena cava filter was malpositioned and tilted to the left with struts extended into the right renal vein. Inferior vena cava filter was tilted with penetration of proximal and distal limbs through the inferior vena cava walls. Approximately eight months later, patient presented with abdominal pain. Subsequent, computed tomography revealed inferior vena cava filter was present with extensive thrombosis inferiorly. Approximately 2 months later, computed tomography revealed medial tilt of the apex and extrusion of struts through the inferior vena cava wall. Eventually, two days later, computed tomography revealed apex tilted to the left and struts protruded through the walls of the inferior vena cava. Few days later, computed tomography revealed an inferior vena cava filter was identified and multiple structures extended through the wall of the inferior vena cava. Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter tilt. 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 and 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 reportedly experienced abdominal pain; however, the current status of the patient is unknown.

 
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Brand NameECLIPSE FILTER SYSTEM
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 Key10319033
MDR Text Key200204714
Report Number2020394-2020-05082
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093659
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 07/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK ECLIPSE
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 Received06/30/2020
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: 07/24/2020 Patient Sequence Number: 1
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