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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 2220J
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pulmonary Embolism (1498); Chest Pain (1776)
Event Date 03/02/2014
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed. The lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported for this lot number and issue to date. Medical records review: the patient with pulmonary emboli (pe), deep vein thrombosis (dvt) in the right leg, and contraindication to anticoagulation had a vena cava filter deployed just above the body of l1. Approximately eight months post filter deployment, the patient was admitted for abdominal pain with gastrointestinal bleeding secondary to diverticulitis. A lumbar spine x-ray was performed which noted the filter at the l2-l3 levels. During admission, the patient complained of shortness of breath and pleuritic chest pain. A ventilation/perfusion scan was intermediately positive for pe. A left lower extremity vascular study demonstrated chronic dvt of the left superficial femoral vein with recanalization of flow was noted with normal compression, augmentation, and respiratory variation of the remaining left lower extremity venous system. The patient was placed on anticoagulation. The status of the filter and current status of the patient is unknown. Investigation summary: the device was not returned for evaluation and images were not provided for review. However, medical records were provided and reviewed. Approximately eight months post filter deployment, a lumbar spine x-ray was performed which noted an ivc filter at the l2-l3 levels. A vq scan was intermediately positive for pe. The filter was noted to originally be deployed at the l1 level. Therefore, based on the medical records, the investigation is confirmed for migration of filter. It can also be confirmed that the patient experienced pe after filter implantation; however, the origin of the pe and the relationship to the filter was not established in the provided medical records. 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. Potential complications: -recurrent pulmonary embolism, this has been reported despite filter usage. It is not known if thrombus passed through the filter or via collateral means. 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 through the litigation process that a vena cava filter was deployed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism. At some time post filter deployment, it was alleged that the patient experienced a pulmonary embolism. The current patient status is unknown.
 
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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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7131632
MDR Text Key95320346
Report Number2020394-2017-01778
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 Attorney
Type of Report Initial
Report Date 12/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2014
Device Model Number2220J
Device Catalogue Number2220J
Device Lot NumberGFVH3772
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/02/2011
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: 12/19/2017 Patient Sequence Number: 1
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