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

Model Number 2120F

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Extravasation (1842); Hematoma (1884)

Event Date 11/29/2012

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, ten years of post-deployment, the patient presented with abdominal pain.A computed tomography abdomen pelvis without contrast.The filter was seen placed at the l2 level.The filter legs penetrated the inferior vena cava wall.Four of them may be penetrating the duodenum.There was a metallic foreign body in the right psoas muscle at the l4 and l5 levels.This could potentially represent a fractured and migrated leg from the inferior vena cava filter.Around, four months and twenty-nine days later, the patient presented to removal of the simon nitinol filter.A recent computed tomography scan showed perforation of the legs outside the lumen of the inferior vena cava and in contact with duodenum causing abdominal pain.The right neck and right groin were accessed.Through the neck sheath, a 5f simon's i catheter and glidewire was used to engage the cone of the filter using the loop snare technique.A snare was also placed through the sheath to snare the filter tip.Traction was applied to the loop snare in an attempt to sheath the filter, however unable to capture the filter due to significant scar tissue formation.Unable to sheath the filter, a follow up venogram was performed which showed extraction of the filter legs from the caval wall with resultant contrast extravasation.Through the groin sheath, a 22f balloon was insufflated across the area of perforation to internally tamponade the extravasation.Follow up venogram showed cessation of active extravasation.Subsequently, the neck sheath was upsized to 18f.Again, a loop snare technique was used to engage the filter.Through the same 18f sheath, endobronchial forceps were inserted along the loop snare and used to grasp the filter tip.Traction was applied to the filter and slowly captured into the sheath and removed.Eventually, four days later, patient presented with severe right sided abdominal pain secondary to intra-abdominal hematomas.There were pericaval hematomas secondary to removal of permanent inferior vena cava filter.The filter was known to have an extension outside the inferior vena cava lumen in contact with duodenum and one leg detached and embedded within right psoas.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc), filter limb detachment and retrieval difficulties.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/pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts detached and retained in right psoas muscle and perforated into the organs.The device has been removed after an attempted but unsuccessful percutaneous removal procedure.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: 11044527
• MDR Text Key: 222623756
• Report Number: 2020394-2020-06501
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• 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: 11/25/2020
• 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: 29 YR