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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 Problem Pulmonary Embolism (1498)
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: a device history record review could not be performed as the lot number is unknown. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately nine years and three months post filter deployment, patient presented with the injury of inferior vena cava and abdominal pain. Subsequent computed tomography (ct) that there was an inferior vena cava in place in the infrarenal inferior vena cava. Some of the legs appeared to have penetrated through the wall of the vena cava. Therefore, the investigation is inconclusive for the alleged perforation of the ivc, filter tilt and pe post implant. Based on the provided medical records, there is no clear evidence to confirm for perforation of the ivc as it reported that, ¿some of the legs appeared to have penetrated through the wall of the vena cava. ¿ 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.

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism and in conjunction with trauma situation/motor vehicle accident. At some time post filter deployment, it was alleged that the filter tilted and struts perforated the vena cava wall and mesentery. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient reportedly experienced pulmonary embolism; however, the current status of the patient is unknown.

 
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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 Key10342587
MDR Text Key200960996
Report Number2020394-2020-05208
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062887
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 07/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF310F
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 Received07/08/2020
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: 07/30/2020 Patient Sequence Number: 1
Treatment
DARVOCET, MORPHINE, ASPIRIN AND NEXIUM; FENOFIBRATE, LISINOPRIL, MULTI-VITAMIN, CRESTOR; LEVAQUIN, COUMADIN, COREG, NEXIUM
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