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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 Obstruction of Flow (2423); Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 06/28/2017
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the alleged perforation of the ivc and occlusion of the ivc filter as no objective evidence has been provided to confirm any alleged deficiency with the filter.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.(expiry date: 01/2011).
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient due to gunshot trauma.At some time post filter deployment, it was alleged that the filter occluded and the struts perforated into the organs.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately after nine years and two months of post filter deployment a computed tomography shows the struts of the filter penetrated the inferior vena cava.Three of the struts penetrated into a segment of jejunum.One strut touched the right lateral wall of the abdominal aorta.One strut touched the anterior cortex of a vertebral body.Therefore, the investigation is confirmed for perforation of inferior vena cava, however the investigation is inconclusive for occlusion.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.H10: d4(expiry date: 01/2011), g3, g4.H11: h6 (method, results).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient due to gunshot trauma.At some time post filter deployment, it was alleged that the filter occluded and the struts perforated into the organs.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.
 
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Brand Name
G2 FILTER SYSTEM - FEMORAL
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key9339723
MDR Text Key166974391
Report Number2020394-2019-04743
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K062887
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF310F
Device Lot NumberGFRL1956
Was Device Available for Evaluation? No
Date Manufacturer Received10/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age49 YR
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