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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problems Pulmonary Embolism (1498); Chest Pain (1776); Dyspnea (1816)
Event Date 04/08/2010
Event Type  Injury  
Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. (b)(4). Journal article citation: desjardins, b. , kamath, s. H. , & williams, d. (2010). Fragmentation, embolization, and left ventricular perforation of a recovery filter. Journal of vascular and interventional radiology, 21(8), 1293¿1296. Doi: 10. 1016/j. Jvir. 2010. 04. 019.

 
Event Description

It was reported in an article in the journal of vascular and interventional radiology (jvir) titled " fragmentation, embolization, and left ventricular perforation of a recovery filter " that 3 years after filter placement, 2 filter struts detached and embolized; one to the right middle pulmonary artery and another perforated the left ventricular wall with tip resting near diaphragm causing pericardial effusion and subsequent chronic pulmonary emboli. Thoracotomy, cardiopulmonary bypass, cardioplegic arrest was required to remove the fragment from heart and 3 days later, another fragment was removed under interventional radiology. The patient recovered well after surgery.

 
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Brand NameRECOVERY 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 Key9930274
MDR Text Key187593930
Report Number2020394-2020-02427
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK031328
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF048F
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 Received08/18/2020
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: 04/06/2020 Patient Sequence Number: 1
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