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

Model Number	2120F
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2001
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, eight months of post deployment, patient had a bleed into his left thigh and the evaluation for thigh hematoma revealed a faulty inferior vena cava filter.The risk of pulmonary embolism was evident with faulty filter and a second filter was placed.After four days later, consultation report stated that inferior vena cava filter placed and required a second filter when the first one became tilted.Around, three years and three months later, x-ray of thoracic spine and lumbar spine was performed for the patient for the clinical indication of catheter dislodgement, which demonstrated that two filters projected over the right paraspinal region in the mid lumbar spine which was likely related to inferior vena cava filters.Around one year later, x-ray of thoracic spine was performed for the patient with back pain which showed inferior vena cava filters were present at the l2 and l3 levels.Around, sixteen years and five months later, x-ray of abdomen was performed for the patient with back pain.The findings of this study indicated interval fracture of a strut of the greenfield filter, with similar appearance of bird's nest filter.On the same date, x-ray of lumbar spine was performed for the patient with low back pain which showed that two filters were present.On the next day, computed tomography angiography of abdomen and pelvis was performed.The impression of this study indicated interval fracture of an anterior strut of the greenfield filter.This strut was noted to extend beyond the wall of the inferior vena cava on the prior study, however there was interval change in its position.Another medial strut also extends more than 3 mm beyond the wall of the inferior vena cava, however, was unchanged in position compared to prior study.No migration of the struts seen.Unchanged position of the simon nitinol filter.Around, seven months later, computed tomography of abdomen and pelvis was performed for the patient with abdominal and right hip pain which showed inferior vena cava filter in appropriate position.Therefore, the investigation is confirmed for filter tilt.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.
Event or Problem Description
It was reported through the litigation process that a vena cava filter was placed in a patient with multiple trauma status post motor vehicle accident, hemothorax and spinal injury.Approximately eight months and fifteen days post filter deployment, it was alleged that the filter tilted.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: SIMON NITINOL FILTER SYSTEM
• Common Device Name: 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 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14446837
• Report Number: 2020394-2022-00382
• Device Sequence Number: 6418158
• Product Code: DTK
• UDI-Device Identifier: 00801741040900
• UDI-Public: (01)00801741040900
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K970099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2120F
• Device Catalogue Number: 2120F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Male