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 Problems Chest Pain (1776); Device Embedded In Tissue or Plaque (3165)

Event Date 05/18/2017

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 one year and three months later, the patient presented for filter removal, the right internal jugular vein was percutaneously cannulated followed by guidewire insertion into the central venous system.The removal sheet was then inserted and placed above the filter.A diagnostic inferior venacavogram was performed to exclude the presence of any neighboring thrombus and there was none.The cone filter removal system was then inserted through the sheath and placed over the filter which was easily engaged.The coaxial sheath was then slid down over the cone and the filter was dislodged and easily removed.After one year and one month, stable linear radiodensity in the left perihilar region, corresponding to a radiopaque density in a left lower lobe pulmonary artery on chest computed tomography, which may represent an embolized leg from an old filter which was removed 1-2 years ago.The patient experienced chest pain.After two weeks, chest x-ray 2 views revealed possible retained limp of the filter in left segmental superior pulmonary artery of lower lobe.Therefore, the investigation is confirmed for alleged filter limb detachment.However, the investigation is inconclusive for alleged perforation of the inferior vena cava.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: 08/2017).

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 detached and struts perforated into organs.The device was removed percutaneously.It was further reported that the detached strut remained in left segmental superior pulmonary artery of lower lobe; however, 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: 11162847
• MDR Text Key: 226549265
• Report Number: 2020394-2020-06546
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• 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: GFYG3610
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 51 YR