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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); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 05/01/2017
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. Medical records were provided and reviewed. Approximately four years seven months later computed tomography revealed that the filter was located at the level. Approximately one month later x-ray lumbar spine revealed the filter overlay the right side of the vertebral body. Approximately one year four months later computed tomography revealed that the filter was noted to the right. Anterolateral filter tilt noted with filter tip contacted with the right anterolateral. At least 11 limbs appeared to perforate and extended outside the inferior vena cava walls. Four posterior limbs approach were in contact with and a lateral limb which was close to the aorta without perforation. Additional 2 linear and oblique metallic densities were noted separate from the limbs lateral to the inferior vena cava and anterior to the inferior vena cava. Approximately five months later, abdomen multiple view and duplex ultrasound of the inferior vena cava were performed, and the filter was noted. Therefore the investigation is confirmed for filter tilt, perforation of inferior vena cava and filter limb detachment. 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.

 
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 into vertebral body. 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 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 Key10336920
MDR Text Key200755928
Report Number2020394-2020-05174
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 07/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2020
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
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: 07/29/2020 Patient Sequence Number: 1
Treatment
CIMZIA, TENORETIC, KLONOPIN, FLEXERIL; FOLVITE, RHEUMATREX, PAXIL; LISINOPRIL-HCTZ, PERCOCET, ZESTORETIC
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