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

Model Number DL900J

Device Problems Malposition of Device (2616); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685)

Event Date 03/12/2018

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.Images were not provided.Medical records were provided and reviewed.Approximately one-year post deployment, ct scan revealed that the filter had turned 90 degrees and the tip of the filter appeared to extend at least 5mm beyond the right lateral wall of the cava and the tip of one of the legs which was apparently bent appeared to have perforated the left sided caval wall.Nine months followed by, ct showed that the filter was tilted about 40 degrees along the axis of the ivc and the tip extended at least 8mm beyond the ivc wall.Also, it was observed that at least two of the filter limbs extended beyond the confines of the ivc.Following month, it was observed that the patient had abdominal and flank pain.Ct scan showed the same previous findings.Two months followed by a ct scan revealed that the patient has a chronic pe on the right lobe.Therefore, the investigation is confirmed for filter limb perforation, filter tilt and material deformation.Additionally, it can be confirmed that the patient experienced pe 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: 08/2019).

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.At some time post filter deployment, it was alleged that the filter tilted and embedded in wall of the ivc and struts perforated into organs.The device has not been removed and there were no reported attempts made to retrieve the filter.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: 9201376
• MDR Text Key: 162679100
• Report Number: 2020394-2019-04053
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• 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: GFAV0680
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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, ADOVY, AMLODIPINE, CALCIUM; CLONAZEPAM, DIVALPROEX SODIUM, FERROUS SULFATE; GABAPENTIN, KEFLEX, MAGNESIUM OXIDE, PANTOPRAZOLE; POTASSIUM CITRATE, PYRIDIUM, ROBAXIN; SIMVASTATIN, SUMATRIPTAN, TOPAMAX, TRAZODONE; VENTOLIN, VITAMIN B12, VITAMIN B3; XARELTO, ZOLOFT
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 36 YR
• Patient Weight: 140