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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. SIMON NITINOL FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Model Number 2120F
Device Problems Occlusion Within Device (1423); Difficult to Remove (1528); Obstruction of Flow (2423); Malposition of Device (2616)
Patient Problems Pulmonary Embolism (1498); Occlusion (1984); Thrombus (2101)
Event Date 07/30/2014
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. This is the only event reported to date for this lot number and failure mode. 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: the patient presented for placement of a vena cava filter. Access was obtained in the left femoral vein, a sheath was inserted and a pigtail catheter was used to perform an inferior vena cavagram to evaluate for the origin of the renal vessels. No clots were seen in the inferior vena cava and the region of the renal veins was delineated. The filter was inserted and placed below the renal veins in a satisfactory position without any complications. The sheath was pulled and pressure held for 10 minutes without any complications. During a filter deployment procedure approximately nine years four months post filter deployment, a venacavogram demonstrated complete occlusion by thrombus of the ivc surrounding the existing filter which was tilted. Presence of the thrombosed ivc filter was believed to possibly be the source of the recurrent pulmonary embolism. A vena cava filter was successfully deployed in the suprarenal ivc. There was no reported complication. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the device was not returned. Images were not provided. Medical records were provided. Approximately nine years four months post filter deployment, a venacavogram demonstrated complete occlusion by thrombus of the ivc surrounding the existing filter which was tilted. Based on the provided medical records, the investigation is confirmed for a tilted filter and occlusion within the device. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: migration of the filter: - this may be caused by placement in oversized venae cavae greater than 28mm, or large migrating thrombus dislodging the filter from its deployed position. Caval occlusion: -the probability of this occurring should be weighed against the inherent risk/benefit ratio for a patient who is experiencing pulmonary embolism, or who is likely to do so without intervention. 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 a vena cava filter was deployed successfully, the reason for the filter deployment was not provided. No alleged deficiency with the device was reported. No other information regarding this event was provided. The patient status at this time is unknown. New information received: medical records were received and reviewed. Approximately nine years four months post vena cava filter deployment. The filter was found to be tilted with thrombus surrounding the filter completely occluding the ivc. The filter was believed to be the cause of recurrent pulmonary embolism. A second vena cava filter was deployed in the suprarenal ivc because the patient could not be anticoagulated. There were no reported complications. No additional medical records were received for this patient.
 
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Brand NameSIMON NITINOL 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 Key6456908
MDR Text Key71623665
Report Number2020394-2017-00303
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970099
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2006
Device Model Number2120F
Device Catalogue Number2120F
Device Lot Number07KN2906
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/05/2003
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: 04/04/2017 Patient Sequence Number: 1
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