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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 Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problem Chest Pain (1776)
Event Date 03/05/2019
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a lot history review was performed. This is the only complaint to date for this lot number. Therefore, a device history record review is not required. Investigation summary: the device was not returned for evaluation. The medical records included images. The image review was documented in the medical records. Medical records were provided and reviewed. On the next day of deployment, computed tomography of abdomen, chest and pelvis with contrast demonstrated that the caval filter was seen in place. Approximately, four years and two months later, computed tomography of abdomen was revealed that an infrarenal inferior vena cava filter with apex approximately 0. 8 cm below lowest renal artery, without migration. The filter was tilted along the lateral right inferior vena cava filter wall. Multiple struts perforated the inferior vena cava wall up to 3-4 mm, without fracture or bent or perforation of adjacent abdominal or vascular structures. Therefore, the investigation is confirmed for the perforation of the inferior vena (ivc) and filter tilt. However, the investigation is inconclusive 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. (expiry date: 02/2017).
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism. At some time post filter deployment, it was alleged that the filter tilted, struts detached and perforated the wall of the inferior vena cava. The device has not been removed and there were no reported attempts made to retrieve the filter. The detached strut retained in chest and the patient experienced chest pain. However, 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 Key10910367
MDR Text Key218694803
Report Number2020394-2020-06449
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 11/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDL900F
Device Catalogue NumberDL900F
Device Lot NumberGFXK3058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2020
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: 11/26/2020 Patient Sequence Number: 1
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