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

Model Number DL900J

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/19/2016

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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, two months and four days of post deployment, patient was planned for filter removal.Through the right internal jugular vein approach, a sheath was advanced over guidewire into the inferior vena cava.Inferior vena cavogram was performed which demonstrated no evidence of thrombus.A snare catheter was advanced through the sheath and utilized to retrieve the filter.Multiple attempts were made to remove the filter with the center with no success.Then a decision was made to utilize the endobronchial forceps.An endobronchial forceps was then advanced through the sheath.After multiple attempts the filter was then removed.Repeat vena cavogram demonstrated no evidence of inferior vena cava clot.A computed tomography of chest, abdomen and pelvis was performed which demonstrated a curvilinear radiopaque foreign body in the infrarenal inferior vena cava which likely represents one of the struts from a removed vena cava filter.Therefore, decision was made to retrieve the fractured strut.Through the right internal jugular vein approach, inferior vena cavogram was performed.This demonstrated no evidence of inferior vena cava thrombus.The filter strut was seen at the renal vein level.A 12 french sheath was advanced into the inferior vena cava.An endobronchial forceps was advanced through the sheath and attempts were made to retrieve this strut.The strut was migrated into the right ventricle.The sheath was pulled back and the right ventricle was accessed.An ensnare was advanced and attempts were made to retrieve the strut from the ventricle with no success.The strut migrated into a segmental branch of the right pulmonary artery.Then the decision was made to terminate the procedure.Therefore, the investigation is confirmed for filter limb detachment and retrieval difficulties.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: 11/2018).

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 strut detached and embedded in the vena cava.The device was removed percutaneously and the detached strut has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

• Brand Name: DENALI JUGULAR 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: 12678826
• MDR Text Key: 277876095
• Report Number: 2020394-2021-80787
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• 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: 10/22/2021

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: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFZJ0454
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/22/2021
• 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: ATORVASTATIN, HYDROXYZINE AND LISINOPRIL; OMEPRAZOLE, SENNA-DOCUSATE AND WARFARIN
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 117