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

Model Number DL900F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/31/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the 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.Approximately five months of post deployment, the computed tomography images displayed the inferior vena cava filter with the tip at the level of the renal veins.There is a 13-millimeter hypoattenuating filling defect just above the inferior vena cava filter and may represent focal nonocclusive thrombus.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with 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 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.

Event Description

It was reported through the litigation process that a vena cava was implanted in a patient for deep vein thrombosis and a high risk for pulmonary embolism.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced thrombus above the filter post-implant; however, the current status of the patient is unknown.

• Brand Name: DENALI FEMORAL 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: 12224872
• MDR Text Key: 263388798
• Report Number: 2020394-2021-80674
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• 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: 07/26/2021

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: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/26/2021
• 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: 76 YR