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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 09/11/2018
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 two days of post deployment, an x-ray abdomen was performed which showed inferior vena cava filter projecting at the t12-l1 level. Two years and six months later, patient presented to the emergency department with the complaints of worsening abdominal pain. A computed tomography of abdomen and pelvis was performed which showed inferior vena cava filter was noted with slight penetration (3-4 mm) of few of the anterior tines of the filter into the posterior margin of the head of the pancreas. Seventeen days later, patient presented for inferior vena cava filter removal. Through the right internal jugular vein approach, a j-wire was advanced through the right atrium and into the inferior vena cava. Contrast was injected demonstrating no evidence of thrombus within the filter and patency of the iliac vein stents. The retrieval snare was then inserted, and the apex of the filter was grasped the filter was then collapsed into the retrieval sheath and removed without difficulty. Contrast was reinjected and imaging demonstrating no evidence of the neck caval wall penetration or defect. Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc). Based on 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: 02/2019).

 
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 the filter struts perforated. The device was removed percutaneously. 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 Key12065039
MDR Text Key258316296
Report Number2020394-2021-80526
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130366
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 06/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDL900F
Device Catalogue NumberDL900F
Device LOT NumberGFAP0128
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2021
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: 06/25/2021 Patient Sequence Number: 1
Treatment
ONDANSETRON, TOLTERODINE AND ZONISAMIDE; OXYMORPHONE, GABAPENTIN AND METOPROLOL; WARFARIN, LEVOFLOXACIN, ALPRAZOLAM AND OXYCODONE
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