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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 Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 10/20/2017
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. Medical records were provided and reviewed. Approximately four years and 15days post filter deployment, computed tomography revealed no pulmonary embolism. After 1 month and 1 day, the patient presented with abdominal pain. After 7 months and 18 days, the patient presented with abdominal pain. After 10 months and 18 days, computed tomography revealed the legs of the filter had penetrated through the wall of the inferior vena cava into the pericaval/mesenteric fat. Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc). 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: 08/2018).
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with left lower extremity deep vein thrombosis and in conjunction before upcoming surgery. Approximately one year and eleven months post filter deployment, a computed tomography (ct) abdomen without contrast revealed that the filter legs perforated the inferior vena cava into the pericaval/mesenteric fat. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient reportedly experienced abdominal 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 Key11384659
MDR Text Key233736262
Report Number2020394-2021-80207
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 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDL900F
Device Catalogue NumberDL900F
Device Lot NumberGFZG3099
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2021
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: 02/26/2021 Patient Sequence Number: 1
Treatment
ATORVASTATIN, ASPIRIN, LISINOPRIL AND OMEPRAZOLE; GABAPENTIN, MORPHINE, PERCOCET AND ONDANSETRON; MIRALAX, NEURONTIN, RIVAROXABAN AND LORTAB
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