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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 X FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number UNK G2X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Death (1802)
Event Type  Death  
Manufacturer Narrative
The device history record (dhr) could not be performed as the lot number is unknown. Investigation summary: the device was not returned for evaluation. Medical records were not provided. Therefore, the investigation is inconclusive for the alleged pe post implant as no objective evidence has been provided to confirm any alleged deficiency with the filter. Based upon 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 some time post vena cava filter deployment that the patient was diagnosed with pulmonary embolism and the patient reportedly expired.
 
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Brand NameG2 X 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 Key10013145
MDR Text Key189438178
Report Number2020394-2020-03293
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082305
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK G2X
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 Received04/08/2020
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: 04/30/2020 Patient Sequence Number: 1
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