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

Model Number DL900J

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problem Chest Pain (1776)

Event Date 11/15/2016

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 review is not required.Investigation summary:the device was not returned for evaluation.Medical records were provided and reviewed.Bard denali filter was deployed into the suprarenal segment of the inferior vena cava just below the confluence of the hepatic veins, for a patient with inferior vena cava thrombus.Appropriate positioning and deployment were confirmed with a post-deployment vena cavogram.Eventually, after two months and twenty-five days later, the patient reported to the hospital with acute onset right-sided chest pain.A ribs unilateral 2 views were revealed an inferior vena cava filter was projected at the level of t11-t12.Approximately, after one year and four months, the patient experienced chest pain.A chest single view was revealed a partially visualized inferior vena cava filter with its tip approximately 2 cm below the level of the right hemidiaphragm.Around, ten months later, a chest 2 views posteroanterior and lateral was revealed stable linear metallic structure at the right hilum compatible with displaced inferior vena cava filter prongs.The inferior vena cava filter otherwise had a stable appearance over the hepatic silhouette.Subsequently, after one year and two months later, a computed tomography (ct) abdomen and pelvis were revealed that the inferior vena cava filter had migrated proximally to the level of the liver.There were 4 fragments of 3 remained at the orthotopic position and within the posterior wall of the inferior vena cava.Three of the legs posteriorly projected beyond the wall of the inferior vena cava.Therefore, the investigation is confirmed for the filter migration, perforation of the inferior vena cava (ivc) and filter limb detachment.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: 02/2017).

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 filter detached, migrated and struts perforated into organs.Reportedly one detached strut retained in lung and three struts retained in inferior vena cava wall.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: 10724359
• MDR Text Key: 212701084
• Report Number: 2020394-2020-06013
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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: GFYA3088
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2020
• 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: PREDNISONE AND CYCLOPHOSPHAMIDE
• Patient Outcome(s): Other
• Patient Age: 49 YR