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

Model Number 2120F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/13/2016

Event Type  Death  

Manufacturer Narrative

Manufacturing review: the device history record (dhr) could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Images were not provided.Medical records were provided and reviewed.Approximately six years post deployment of g2 filter, patient had an intractable back pain.Ct scan revealed that the ivc filter was migrated and is partially within the right atrium and partially within the intrahepatic portion of the ivc.Also, it was observed in abdominal ultrasound that there was a thrombosis of the ivc with dislodged filter at the junction of the ivc and right atrium.There is a linear apparently metallic structure that extends from the ivc into the right atrium and likely represents the ivc filter and thrombus likely attached to that and this required retrieval of the existing filter and placed another permanent ivc filter.Five days later, after multiple attempts with recovery cone and snare catheter, the filter was cannulated.Then snf filter was deployed successfully in good position.Approximately 10 months post deployment of snf, patient met a motor vehicle accident and underwent multiple orthopedic surgeries.Four years followed by, patient died due to septic shock, cardiogenic shock, myocardial infarction, pneumonia and there are significant conditions were clotting disorder, coronary artery disease and renal failure.There were no device deficiencies identified within the medical records for simon nitinol filter (snf).Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with simon nitinol filter (snf).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.

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.No alleged deficiency with the filter was reported.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The patient subsequently expired.

• 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: 9267625
• MDR Text Key: 164658685
• Report Number: 2020394-2019-04350
• 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: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2019
• 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: COUMADIN
• Patient Outcome(s): Death
• Patient Age: 51 YR
• Patient Weight: 117