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

Model Number DL900J

Device Problem Malposition of Device (2616)

Patient Problems Thrombosis (2100); Thrombus (2101)

Event Date 09/05/2016

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date:02/2018).

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, and pulmonary embolism.Approximately one year and three months, post filter deployment it was alleged that the filter malpositioned and the device was removed.The patient reportedly diagnosed with thrombosis and thrombus above the filter; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: 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.Approximately, one year and three months of post deployment, the patient was hospitalized and diagnosed with embolism and thrombosis of the renal vein and inferior vena cava.There was acute occlusive thrombosis of the infra renal inferior vena cava.The apex of the filter was positioned well below the level of the renal veins.Thrombus currently extended above the filter to the renal veins.Unknown test revealed displacement of the umbrella device, complete bilateral iliocaval venous thrombosis extended through the mal-positioned filter and up to the level of the renal veins and the filter was retrieved.Therefore, the investigation is confirmed for malposition of the filter.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.H10: d4(expiry date:02/2018),g4.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

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.Approximately one year and three months, post filter deployment it was alleged that the filter malpositioned and the device was removed.The patient reportedly diagnosed with thrombosis and 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
• MDR Report Key: 11071113
• MDR Text Key: 223582476
• Report Number: 2020394-2020-06504
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• Combination Product (y/n): N
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

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: GFZA0723
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 12/25/2020
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR