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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2018
Event Type  malfunction  
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: 11/2016).
 
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, and contraindication for anticoagulation.Approximately two years and five months post filter deployment, it was alleged that the struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.
 
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, and contraindication for anticoagulation.Approximately two years and five months post filter deployment, it was alleged that the struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.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.Approximately two years and five months later, computed tomography of the abdomen and pelvis revealed the filter was at inferior l1 to superior l3 interspace.Migration was unlikely based on the study.No significant tilt (coronal 11 degrees to the right).Grade 1 perforation was demonstrated.Therefore, the investigation is confirmed for the perforation of the inferior vena cava.The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 11/2016).H11:section a through f - the information provided by bd 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 bd.H3 other text : device not returned.
 
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Brand Name
DENALI FEMORAL SYSTEM
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key11936900
MDR Text Key254302057
Report Number2020394-2021-01168
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00801741040801
UDI-Public(01)00801741040801
Combination Product (y/n)N
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 06/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDL900F
Device Catalogue NumberDL900F
Device Lot NumberGFXI2513
Was Device Available for Evaluation? No
Date Manufacturer Received06/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age50 YR
Patient Weight94
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