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

Model Number DL900F

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 03/07/2019

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 for evaluation.Medical records were provided and reviewed.Approximately three years post filter deployment, patient presented with abdominal pain.On the same day, an x-ray abdomen complete and posteroanterior chest x-ray showed an inferior vena cava filter.Approximately two years later, computed tomography revealed six proximal prongs appeared embedded within the inferior vena cava wall without significant extraluminal extension.The more distal prongs each extended approximately 2-3 mm beyond the margin of the inferior vena cava.Most pronounced extraluminal extension was at the 8 o'clock position, where it extended approximately 3.6 mm beyond the wall.However, no evagination of these extraluminal extended prongs was seen into the surrounding vasculature, osseous structures, or solid organs.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).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: 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.Approximately four years and ten months post filter deployment, a computed tomography (ct) abdomen without contrast revealed that the filter struts perforated the inferior vena cava wall.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced acute abdominal pain; 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: 11377135
• MDR Text Key: 233484917
• Report Number: 2020394-2021-80205
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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: GFXL1922
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HYDRODIURIL, PROTONIX, PERCOCET AND AVELOX; NORVASC, ELIQUIS, LIPITOR, FLEXERIL AND COLACE; PRINZIDE, ZESTORETIC, ZANTAC, COUMADIN AND MOBIC; TAMIFLU, DELTASONE, ZYLOPRIM AND TRAMADOL
• Patient Outcome(s): Other
• Patient Age: 63 YR