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

Model Number DL900J

Device Problems Obstruction of Flow (2423); Activation, Positioning or Separation Problem (2906)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/02/2014

Event Type  Injury  

Manufacturer Narrative

A device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.The medical records allege bard denali filter was implanted in the infrarenal location for a patient.The filter was incompletely expanded during deployment.Approximately eight months later, inferior vena cavagram revealed thrombus extends across the filter suprarenal in location approximately 2 vertebral bodies.Thrombus around the filter and above the filter.Large obstructing clot at the level of the filter.After four years and five months, inferior venacavogram revealed complete occlusion of thrombosed filter.Therefore, the investigation is confirmed for the alleged partial deployment and filter occlusion.Additionally, it can be confirmed that the patient experienced thrombus above the filter 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.

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, and pulmonary embolism.During deployment, the filter was incompletely expanded.Approximately eight months post filter deployment, it was alleged that the filter was occluded completely.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with thrombus above the filter; however, 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: 11972460
• MDR Text Key: 255604710
• Report Number: 2020394-2021-80488
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 169