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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 Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/15/2016
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 provided and reviewed. Approximately, five years ten months of post deployment, a computed tomography study was performed, which showed that a fragment was noted in the right lung. Around, one year and five months later, an x-ray shoulder was performed for history of fall. The study showed that a linear radiodense fragment was noted in the right chest. This was felt to represent filter fragmentation and distal embolization to the pulmonary arterial tree. After, two months and eighteen days, patient was planned for inferior vena cava filter removal. Through the right internal jugular vein, a sheath was advanced into the distal inferior vena cava. Venogram was performed which showed a fractured bard inferior vena cava filter with mild caval stenosis and no thrombus was noted above, within or below the filter. The superior segment of the existing filter was snared by utilizing a loop snare. The inner sheath dilator was advanced over the snared filter due to endothelialization of the filter apex hook. The decision to use the forceps was made and used to gently dissect the apex of the filter hook from the wall of the inferior vena cava. The apex hook was grasped with the forceps and gently retracted into the inner sheath. The forceps were released and exchanged for the trilobed snare, which engaged the apex hook of the filter and removed through the sheath. The legs and arms of the inferior vena cava filter were counted and the single filter arm in the right subsegmental pulmonary artery. Then the outer sheath was retracted into the superior vena cava. Multiple different catheters, microcatheters, wires and snares were used to try and access the inferior right upper lobe subsegmental pulmonary artery where the retained inferior vena cava filter arm had lodged without success. This was felt to be due to thrombosis of the targeted pulmonary artery. Given the thrombosed nature of the artery, the decision to terminate the procedure was made and catheter was removed. Therefore, the investigation is confirmed for the filter limb detachment and retrieval difficulties. However, the investigation is inconclusive for filter tilt and perforation of the inferior vena cava (ivc). 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. (expiry date: 11/2012).
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident. At some time post filter deployment, it was alleged that the filter tilted, detached and the struts perforated into organs and embedded in the wall of ivc. The device was removed percutaneously after an attempted but unsuccessful percutaneous removal procedure but the removal procedure cannot be classified as successful because a single strut was unretrievable and retained in body in pulmonary artery tree and right lung. 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 Key12156825
MDR Text Key261200453
Report Number2020394-2021-80559
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 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF310F
Device Lot NumberGFTJ1625
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2009
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: 07/13/2021 Patient Sequence Number: 1
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