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

Model Number DL900F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problem Pulmonary Embolism (1498)

Event Date 06/08/2016

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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately four months later, inferior vena cava filter removal was attempted, filter was somewhat tilted but was free of clot.The hook appeared to be embedded into the caval wall.Attempts were made to snare the filter, these all proved unsuccessful.The patient tolerated the procedure well and was taken to recovery area without complications.The inferior vena cava was patent.There was no evidence of thrombus within the filter.The filter was tilted with the hook adjacent to the left caval wall.After one year and one-month, computed tomography of abdomen and pelvis without contrast was performed which revealed an inferior vena cava filter in the suprarenal inferior vena cava.On the same day, x-ray of chest posteroanterior, lateral was performed, and inferior vena cava filter was partially visualized.On the next day, computed tomography of chest with contrast was performed and inferior vena cava filter was partially visualized.There was no evidence of any large pulmonary embolism.After two months, computed tomography of abdomen with and without contrast was performed which revealed an inferior vena cava filter was again noted.Half of the filter was above the level of the renal veins.It may be placed high or may have migrated to this position.The filter was tilted to the right with its cone penetrating through the wall of the inferior vena cava into the pericaval fat.This may render the filter non removal.Some of the filter struts have penetrated through the wall of the inferior vena cava into the pericaval and mesenteric fat.After four months, the patient had chest pain, computed tomography of chest with and without contrast was performed which revealed there was a large eccentric filling defect in the right lower lobe segmental pulmonary artery consistent with thrombus and the patient was diagnosed with pulmonary embolism.Infrarenal inferior vena cava filter noted in place and was partially visualized.An attempt to remove the filter later by vascular surgery was unsuccessful.On the next day, bilateral pulmonary angiogram was performed which revealed catheter was advanced into the left pulmonary artery through inferior vena cava filter and ekosonic endovascular system catheter was placed in right pulmonary artery for a patient with submassive pulmonary embolism or intermediate high risk pulmonary embolism.Therefore, the investigation is confirmed for the alleged filter tilt, perforation of the inferior vena cava, filter migration and retrieval difficulties.Additionally, it can be confirmed that the patient experienced pulmonary embolism 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: 04/2017).

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 inferior vena cava.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: 12172049
• MDR Text Key: 261652381
• Report Number: 2020394-2021-80565
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• 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: GFYC3722
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2014
• 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
• Patient Age: 69 YR
• Patient Weight: 136