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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER 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 Abdominal Pain (1685); Chest Pain (1776); Palpitations (2467)
Event Date 04/09/2008
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. Journal article citation: hull, j. E. , han, j. , & giessel, g. M. (2008). Retrieval of the recovery filter after arm perforation, fracture, and migration to the right ventricle. Journal of vascular and interventional radiology, 19(7), 1107¿1111. Doi: 10. 1016/j. Jvir. 2008. 03. 011. (b)(4).

 
Event Description

It was reported in an article in the journal of vascular and interventional radiology (jvir) titled " retrieval of the recovery filter after arm perforation, fracture, and migration to the right ventricle " that several weeks after filter placement, computed tomography (ct) demonstrated that the 3 filter arms and one lower limb of the filter had penetrated the inferior vena cava (ivc). Two years later, the patient presented with right-sided abdominal and chest pain; current ct demonstrated that 2 of the perforating arms had fractured and migrated to the right ventricle requiring an additional intervention to remove the filter and the migrated arm with a resolution of chest pain and palpitation.

 
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Brand NameRECOVERY FILTER
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 Key9878833
MDR Text Key185227915
Report Number2020394-2020-02011
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 07/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
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 Received07/24/2020
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: 03/25/2020 Patient Sequence Number: 1
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