MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM; VENA CAVA FILTER

Model Number DL900F

Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problem Pulmonary Embolism (1498)

Event Date 11/27/2016

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 five months later, the patient presented to the hospital with chest pain, a computed tomography angio (cta) chest with contrast was performed and it revealed small non-occlusive pulmonary embolism with a sub segmental branch involving the posterior basal segment of the left lower lobe.Embolized fractured inferior vena cava filter strut within a segmental branch to the anterior basal segment of the right lower lobe.An x-ray abdomen one view was performed, and it revealed there was missing one leg without the claw.Thus, the radiopaque density seen in the right chest likely is a leg of the inferior vena cava filter.An x-ray chest 1 view was performed, and it revealed linear metallic densities are seen over the right lower lobe.Therefore, the investigation is confirmed for alleged filter detachment.However, the investigation is inconclusive for the perforation of the ivc.Additionally, it can be confirmed that the patient experienced pe post-deployment.However, the relationship to the filter is unknown.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.

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 detached, perforated into the organs.The device has not been removed and there were no reported attempts made to retrieve the filter.It was further reported that the detached strut retained in right lower lung.The current status of the patient is unknown.

• 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
• 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 Key: 10182798
• MDR Text Key: 196046893
• Report Number: 2020394-2020-04024
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFAR4010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/23/2020
• 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 Sequence Number: 1
• Treatment: COREG, FLEXERIL, FLOMAX, LASIX AND NOVOLOG MIX
• Patient Outcome(s): Life Threatening
• Patient Age: 44 YR