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

Model Number	2120F
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2011
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.Bard simon nitinol filter was deployed in the inferior vena cava, inferior to the renal veins for a patient with pulmonary embolism.An inferior vena cavogram confirmed the appropriate placement of the filter.Approximately, four months and twenty-six days of post-deployment, computed tomography of the chest confirmed no evidence of pulmonary embolism.Around, twenty-two days later, computed tomography of the abdomen was conducted.There was cephalad migration of the apex of the filter which was at or just above the level of the left renal vein.A lateral tilt was noted at 13 degrees, but the apex of the filter did not touch the inferior vena cava wall.Perforation was noted of 2 medial struts of 8 millimeters and 6 millimeters.The top of the strut that perforated by 8 millimeters extended into the lower body of the pancreas.There was a 6-millimeter posterolateral strut perforation.A 2.1-centimeter metallic linear foreign body in the right hepatic lobe was noted, which most likely represented strut migration post-fracture.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc) and filter migration.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.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 pulmonary embolism.At some time post filter deployment, it was alleged that the filter had perforated and migrated.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
• MDR Report Key: 12482245
• Report Number: 2020394-2021-01716
• Device Sequence Number: 14405796
• Product Code: DTK
• UDI-Device Identifier: 00801741040900
• UDI-Public: (01)00801741040900
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K970099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

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: 08/20/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LORAZEPAM, MEPERIDINE, METOPROLOL; PROMETHAZINE, AND WARFARIN
• Patient Age: 60 YR
• Patient Weight: 83