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

Model Number DL900F

Device Problems Malposition of Device (2616); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problem Pulmonary Embolism (1498)

Event Date 06/05/2015

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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately after 2 weeks post filter deployment on (b)(6) 2015, a ct scan showed the presence of acute pe in the lower lobe.On the same day, the filter explant was scheduled.Access was gained through the left femoral vein access, venogram showed a nearly occlusive thrombus in the bilateral iliac veins extending all the way up to the filter.Decision was made to retain the ivc filter as such as it was found to be very deformed with at least 4 stabilizing bars of the filter tilted upwards.Later, ct angiogram performed on (b)(6) 2015, showed the ivc filter posteriorly tilted by 45 degrees and the retrievable hook was outside the wall of the ivc posteriorly.A couple of the legs of the filter were a few millimeters outside the wall of the ivc.A single leg appeared to be pointing upwards.On (b)(6) 2015, the filter was removed out using anterior cavotomy open surgical procedure.All the mal positioned filter struts as well as the feet were carefully removed including one of the filter struts spiking cephalad.Then the filter feet as well as the struts were cut using a wire cutter and then the hook of the filter that was penetrating through the posterior wall of the cava was carefully negotiated and removed in a secure fashion.Therefore, the investigation is confirmed for filter tilt, material deformation, and perforation.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.(expiry date: 12/2017).

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 tilted and embedded in wall of the ivc.The device was removed via an open abdominal and an open chest procedure.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: 9398657
• MDR Text Key: 168922727
• Report Number: 2020394-2019-05097
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFYK2894
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2019
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 57 YR