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

Model Number 2220J

Device Problem Obstruction of Flow (2423)

Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)

Event Date 09/05/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a 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, one month twenty-five days of post deployment, computed tomography of chest with contrast revealed a small pulmonary embolism was identified in the right mainstem branches and leads to the right lower lobe.This embolus was largest in size on prior exam and may be residual emboli or possible new embolus.Vq scan revealed a new onset of right-side pulmonary embolism.There was a thrombus above the filter.Around, three months later, computed tomography of chest with contrast revealed possible for pulmonary embolism in the right lower lobar branch of the right pulmonary artery and possible in the posterior segmental branches of the left lower lobe.On the next day, computed tomography of chest showed and not clear if the pulmonary embolism was new or old.Around one year and three months later, chest x-ray revealed nonocclusive pulmonary embolus in the left lower lobe.On the same day, computed tomography of chest with contrast revealed intraluminal thrombus was identified in the pulmonary artery, extended to the left lower lobe.The filter was occluded.Around, one month later, computed tomography of chest with contrast revealed there are filling defects in the sub segmental and segmental pulmonary arteries of the left upper lobe and left lower lobe.Small filling defect in sub segmental pulmonary artery in the right lower lobe.After, eighteen days, computed tomography of chest with contrast revealed the pulmonary emboli identified on prior exam was no longer identified.A tiny residual thrombus was identified in an arterial branch of the left lower lobe.Therefore, the investigation is confirmed for the occlusion of the inferior vena cava (ivc).Additionally, it can be confirmed that the patient experienced pe post deployment and 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.

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.At some time post filter deployment, it was alleged that the filter occluded.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly diagnosed with pulmonary embolism and experienced thrombus above the filter; however, the current status of the patient is unknown.

• Brand Name: SIMON NITINOL FILTER 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: 11981712
• MDR Text Key: 255617222
• Report Number: 2020394-2021-80500
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040917
• UDI-Public: (01)00801741040917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970099
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2220J
• Device Catalogue Number: 2220J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• 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
• Treatment: GABAPENTIN, REGLAN, PANTOPRAZOLE, CLONIDINE; LOVENOX, METOPROLOL, RAMIPRIL, PROTONIX; WARFARIN
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 37 YR
• Patient Weight: 122