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

Model Number DL900F

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.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.Medical records were provided and reviewed.Approximately four months of post deployment, computed tomography angiogram of chest with and without contrast was performed which showed extensive bilateral pulmonary emboli.Specifically, there was significant thrombus within the right pulmonary artery extending contiguously into lobar branches of the right middle and right lower lobes as well as into segmental and subsegmental pulmonary arteries of the right middle and right lower lobes which are not opacified by intravenous contrast.Lntraluminal filling defects are also identified within segmental and subsegmental pulmonary arteries of the right upper lobe.Within the left lung, nonocclusive thrombus was identified within segmental and subsegmental branches of the left lower lobe.Occlusive thrombus was identified within the right pulmonary artery as well as within lobar, segmental and subsegmental pulmonary arterial branches of the right middle and right lower lobes.Pulmonary emboli are also identified within lobar, segmental and subsegmental branches of the right upper lobe.Minimal intraluminal thrombosis was also identified within segmental and subsegmental branches of the left lower lobe pulmonary artery.The inferior vena cava filter was mildly constricted at the level of the attachment of legs of the bard filter.Around two days later, bilateral pulmonary artery angiogram was performed for placement of suprarenal inferior vena cava filter because prior one was clotted which showed findings consistent with chronic pulmonary embolism in branches to bilateral lower lobes, with little change in appearance post thrombolysis and attempted mechanical thrombectomy to a branch of right pulmonary artery to the lower lobe.Persistent thrombus in and above the infrarenal inferior vena cava filter.In addition, a large filling defect was seen within the upper cone of the infrarenal inferior vena cava filter with extension superior to the filter reaching the level of the renal veins.Perhaps, more of this filling defect was above the level of the filter.This was of concern for producing further pulmonary embolism, so an argon option elite filter was deployed in the suprarenal inferior vena cava.Both filters are potentially retrievable filters.Therefore, the investigation is confirmed for material deformation.However, the investigation is inconclusive for retrieval difficulties.Additionally, it can be confirmed that the patient experienced pulmonary embolism and thrombus above the filter post deployment.However, the relationship to the filter is unknown.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: 03/2019).

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.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The patient was diagnosed with pulmonary embolism post implant; 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: 12237273
• MDR Text Key: 263838348
• Report Number: 2020394-2021-80677
• 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: 07/28/2021

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 Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFAP3470
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2016
• 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: ALBUTEROL SULFATE, APIXABAN; BACTRIM AND TRAZADONE; BUDESONIDE/ FORMOTEROL FUMARA, SODIUM CHLORIDE; CYCLOBENZAPRINE, DULOXETINE, ERGOCALCIFEROL; ESCITALOPRAM OXALATE, KETOROLAC, LISINOPRIL; HEPARIN, TYLENOL, IBUPROFEN, CLONAZEPAM; LORAZEPAM, MELOXICAM, NASONEX, OXYCODONE; SIMVASTATIN, SITAGLIPTIN PHOSPHATE
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 35 YR
• Patient Weight: 90