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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN G2
Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
Event Date 12/19/2012
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: malek, j. Y. , kwolek, c. J. , conrad, m. F. , patel, v. I. , watkins, m. T. , lancaster, r. T. , & lamuraglia, g. M. (2013). Presentation and treatment outcomes of patients with symptomatic inferior vena cava filters. Annals of vascular surgery, 27(1), 84¿88. Doi: 10. 1016/j. Avsg. 2012. 06. 005.

 
Event Description

It was reported in an article in the journal of annals of vascular surgery titled " presentation and treatment outcomes of patients with symptomatic inferior vena cava filters " that 3 patients presented with back pain and computed tomography (ct) scan identified filter tilt with strut erosion; in two patients strut penetrated into vertebral spinal body and in one patient into duodenum. A complete resolution of symptoms occurred in the immediate postoperative period of endovascular device removal.

 
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Brand NameG2 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 Key9954835
MDR Text Key187596331
Report Number2020394-2020-02639
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
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 08/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN G2
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: 04/13/2020 Patient Sequence Number: 1
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