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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF310F
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Death (1802)
Event Date 02/18/2016
Event Type  Death  
Manufacturer Narrative
Manufacturing review: a lot history review was performed. This is the only complaint to date for this lot number. Therefore, a device history record (dhr) review is not required. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately seven years and three months post filter deployment, computed tomography ct was performed as the patient had right abdominal pain and swelling and it revealed that an inferior vena cava filter was seen in the region of the l3-l4 vertebral bodies. The report showed tilting of inferior vena cava filter with struts of the filter projecting outside the lumen of the inferior vena cava and were seen both anterior and posterior to the abdominal aorta suggesting the malposition. No other significant findings to explain patient¿s right sided abdominal pain. Therefore, the investigation is confirmed for the alleged perforation of the ivc and filter tilt. 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. Medical device - expiry date: 09/2011.
 
Event Description
It was reported through the litigation process that a vena cava filter was deployed successfully, the reason for the filter deployment was not provided. After some time post filter deployment, it was alleged that the filter tilted and struts perforated. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient experienced abdominal pain and reportedly expired.
 
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Brand NameG2 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 Key10074314
MDR Text Key191534673
Report Number2020394-2020-03424
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062887
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 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF310F
Device Lot NumberGFSH3639
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2020
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: 05/20/2020 Patient Sequence Number: 1
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