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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN G2
Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Pain (1994)
Event Date 05/13/2015
Event Type  Injury  
Manufacturer Narrative
This event was identified in a journal article (attached) and the article has been reviewed. Journal citation: hannawa, k. K. , good e. D. , haft, j. W. , & williams, d. M. (2015). Percutaneous extraction of embolized intracardiac inferior vena cava filter struts using fused intracardiac ultrasound and electroanatomic mapping. Journal of vascular interventional radiology, 2015; 26: 1368-1374. Http://dx. Doi. Org/10. 1016/j. Jvir. 2015. 05. 013. The investigation is currently on-going. The information provided by bard 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 bard.
 
Event Description
It was reported that approximately ten years post inferior vena cava filter deployment for gastric bypass surgery, ct scan demonstrated a detached filter limb within the free wall of the right ventricle. Intracardiac echocardiography and 3d electroanatomic mapping and vascular retrieval forceps were used to successfully capture and retrieve the detached filter limb. The patient complained of chest pain and during the procedure developed atrial fibrillation, which required synchronized cardioversion. A twenty one day ambulatory electrocardiographic monitoring study was negative, and the arrhythmia did not recur.
 
Manufacturer Narrative
A manufacturing review could not be conducted as the lot number was not provided. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: based on the image provided, a high density linear foreign body in the right ventricle can be confirmed. The removal of the high density linear foreign body in the right ventricle cannot be confirmed, and the identity of the high density linear foreign body in the right ventricle cannot be confirmed. Conclusion: a radiopaque linear metallic foreign body located in the heart can be confirmed; however, the identity of the object cannot be confirmed. Therefore, the investigation is inconclusive for a detached filter limb. Per the journal article, the patient had the filter placed prior to gastric bypass surgery. Per the instructions for use (ifu), "procedures or activities that lead to changes in intra-abdominal pressure could affect the integrity or stability of the filter. " therefore it is possible that the procedure contributed to the reported event. However, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: warnings/potential complications: filter fractures are a known complication of vena cava filters. There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.
 
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Brand NameG2 FILTER SYSTEM
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 west 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1625 west 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5419545
MDR Text Key37784837
Report Number2020394-2016-00166
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN G2
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2016
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: 02/09/2016 Patient Sequence Number: 1
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