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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 X FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF400F
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Detachment of Device or Device Component (2907); Extrusion (2934)
Patient Problems Atrial Fibrillation (1729); Pain (1994)
Event Date 01/14/2016
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: 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: no medical images have been made available to the manufacturer. Conclusion: the investigation is inconclusive for the reported event. Based upon the available information, the definitive root cause for this event 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. Note: it is possible that complications such as those described in the "warnings", "precautions," or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted. Perforation or other acute or chronic damage of the ivc wall. 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 seven months post vena cava filter deployment for a planned surgical procedure, an attempt to retrieve the filter was unsuccessful. Allegedly, the filter was presumed to have possibly broken with a limb embedded in the vein and filter limb(s) extending beyond the caval wall near the pancreas. It was further alleged that as a direct result of the filter remaining implanted, the patient continues to have sporadic pain below the sternum and over the breast bilaterally; additionally, he now experiences shortness of breath upon exertion and atrial fibrillation. There was no additional patient or event information was provided in the report received.
 
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Brand NameG2 X 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 Key5612547
MDR Text Key43839821
Report Number2020394-2016-00407
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K082305
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF400F
Device Lot NumberGFYI2694
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2020
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: 04/27/2016 Patient Sequence Number: 1
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