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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 Extrusion (2934); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stroke/CVA (1770)
Event Date 12/11/2015
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a manufacturing review was performed. The lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported to date for this lot number and failure mode. Investigation summary: the device was not returned for evaluation. Images were not provided for review. Medical records were provided and reviewed. There was no specific deficiency alleged in the provided medical records. Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: potential complications: procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at any time during or after the procedure. Possible complications include, but are not limited to, the following: stroke.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed after being diagnosed with deep vein thrombosis/ pulmonary embolism. Some time post filter deployment (date not provided), the patient allegedly experienced a middle cerebral artery stroke. Patient status was not provided.
 
Manufacturer Narrative
No medical images have been made available to the manufacturer. Medical records were provided and reviewed. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. Medical records review: the patient presented with severe pulmonary embolisms from deep venous thrombosis and a vena cava filter was deployed in the infrarenal position. The patient tolerated the procedure well and was transferred to the recovery room in stable condition. No further information was provided regarding the current status of the patient. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed after being diagnosed with deep vein thrombosis/pulmonary embolism. Some time post filter deployment (date not provided), the patient allegedly experienced a middle cerebral artery stroke. Patient status was not provided.
 
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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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7125055
MDR Text Key254227119
Report Number2020394-2017-01769
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 Attorney
Type of Report Initial,Followup,Followup
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2015
Device Catalogue NumberEC500F
Device Lot NumberGFVL0176
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2012
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: 12/18/2017 Patient Sequence Number: 1
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