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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 Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)
Patient Problems Abdominal Pain (1685); Chest Pain (1776)
Event Date 07/19/2017
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. (expiry date: 05/2019).
 
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 filter migrated, struts perforated and detached. The device and the detached struts has not been removed and there were no reported attempts made to retrieve the filter. The detached strut retained in the right lower lobe within the pulmonary artery. 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 Key11700292
MDR Text Key246469713
Report Number2020394-2021-80355
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,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDL900F
Device Catalogue NumberDL900F
Device Lot NumberGFAR3088
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2021
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: 04/21/2021 Patient Sequence Number: 1
Treatment
ACETAMINOPHEN, ALBUTEROL AND CAPSAICIN; CYANOCOBALAMIN, CYCLOBENZAPRINE AND ENOXAPARIN; FAMOTIDINE, FLUTICASONE, FUROSEMIDE AND INSULIN; LOSARTAN, MESALAMINE ER AND METOPROLOL; MULTIVITAMIN, POLYETHYLENE GLYCOL AND PREDNISONE; PROGRAF, PROMETHAZINE AND SPIRONOLACTONE; TERAZOSIN, TRAMADOL, URSODIOL AND VITAMIN D3
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