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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM VENA CAVA FILTER Back to Search Results
Model Number DL900F
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/15/2019
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: the device history record review could not be performed as the lot number is unknown. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately three years and eight months of post deployment, a wire was seen in the pericardium. Two months later, the patient presented with back pain, there is a wire in the pericardium. There was a fractured tine in the right ventricle for an unknown duration. Selective coronary angiography was done. With regards to the patient's questionable fractured inferior vena cava filter, it was planned to discuss with the patient regarding possible retrieval of the leg of the filter. It was unclear how long it had been there and may be epithelializing in the myocardium at that point. One month later, the patient presented for filter removal. At this point it was not sure if the filter was within the chamber of the heart or had penetrated into the muscle of the heart. A cat scan without contrast was planned to better evaluation the position of the fractured tine. An xr-abdomen scan done one month later was done post filter retrieval on an unknown date. There was no evidence of an inferior vena cava filter. Therefore, the investigation is confirmed for filter limb detachment. 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.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with lumbar spine surgery. Approximately four years post filter deployment, it was alleged that the filter strut detached and migrated to the heart. The device has been removed successfully via a percutaneous removal procedure. The current status of the patient is unknown.
 
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Brand NameDENALI FEMORAL 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 Key11870122
MDR Text Key252168611
Report Number2020394-2021-80461
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130366
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 05/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDL900F
Device Catalogue NumberDL900F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2021
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: 05/24/2021 Patient Sequence Number: 1
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