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

Model Number 2120F

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 09/30/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, five years one month of post deployment, computed tomography of the abdomen and pelvis was revealed that the filter was in the lower portion of the inferior vena cava with its superior tip at l4 level.There was penetration of all the legs through the inferior vena cava wall with 2 of the struts coursing tangential to the anterior and posterior walls of the abdominal aorta.Two struts abut the lumbar spine, and another strut penetrates into the right psoas muscle.The patient reportedly experienced abdominal pain and back pain.The filter tilted.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc) and filter tilt.The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 06/2013).

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.Approximately five years and one month post filter deployment, it was alleged that the filter tilted, and struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal and back pain; 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 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11981800
• MDR Text Key: 255618708
• Report Number: 2020394-2021-01202
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040900
• UDI-Public: (01)00801741040900
• 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: 06/04/2021

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: 2120F
• Device Catalogue Number: 2120F
• Device Lot Number: GFUE3454
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• 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: 60 YR