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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 Pulmonary Embolism (1498)
Event Date 08/18/2016
Event Type  Injury  
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 three years and ten months of post deployment, patient presented with the complaints of chest pain. A computed tomography angiogram of chest was performed which showed moderately large bilateral pulmonary thromboembolism. Around one year and three months later, a computed tomography of abdomen was performed for filter evaluation. The study showed that inferior vena cava filter was noted at the level of renal veins. The filter was somewhat tilted with the cephalad aspect likely abutting the right lateral wall of the inferior vena cava. The struts extend beyond the lumen of the inferior vena cava with a strut at approximately 7 o¿clock likely extending into the right psoas muscle. Remaining struts extend minimally into the adjacent fat. Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc) and filter tilt. Additionally, it can be confirmed that the patient experienced pe post deployment. However, the relationship to the filter is unknown. 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. (expiry date: 06/2015).
 
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 two months post filter deployment, a computed tomography scan showed that the filter tilted and perforated the inferior vena cava with one strut perforating into the psoas muscle. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient was diagnosed with pulmonary embolism post implant; 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 Key12237113
MDR Text Key263809971
Report Number2020394-2021-80676
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 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEC500F
Device Lot NumberGFWE3382
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2012
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: 07/28/2021 Patient Sequence Number: 1
Treatment
ASPIRIN, LEVAQUIN AND LOVENOX; MORPHINE SULFATE AND TYLENOL
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