MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM; VENA CAVA FILTER

Catalog Number UNKNOWN G2

Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Manufacturer Narrative

The device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Post filter deployment, a bilateral lower extremity angiography showed an inferior vena cava filter with similar appearance of the fractured right lateral strut extended into the retroperitoneal fat.No surrounding hemorrhage was noted.A computed tomography (ct) abdomen and pelvis showed an infrarenal inferior vena cava filter with fracture of a right lateral strut and migration of the strut into the retroperitoneal fat inferiorly and laterally, with increased migration compared to a week earlier, but grossly unchanged compared to six days earlier.The next day, the patient presented with chest pain.The next day, the patient presented with chest pain.On the same day, during the heart surgery, a linear radio-opaque structure was noted in the vicinity of the right ventricles, or possibly in a pulmonary artery, and moved with the cardiac cycle.This might be a strut from the patient¿s inferior vena cava filter.The patient had an inferior vena cava filter in place.Also, a computed tomography angiography (cta) chest with intravenous contrast showed no pulmonary emboli.The next day, the patient presented with epigastric pain.On the same day, a computed tomography angiography (cta) chest showed that there was an inferior vena cava filter with similar appearance of the fractured right lateral strut extended into the retroperitoneal fat, unchanged.No filling defect was seen to suggest pulmonary embolus.No surrounding hemorrhage was noted.Four days later, the patient presented with abdominal pain and fractured inferior vena cava filter.On the same day, a kidney, ureter and bladder (kub) 1 view showed that an inferior vena cava filter was in place.A fractured tine remained inferior, but might be slightly closer to the intact portion of the filter compared to the prior study.Seven months and twenty days later, a computed tomography (ct) abdomen showed that there was a bard g2 inferior vena caval filter with the apex located approximately 3.4 cm below the left renal vein.There was no left or right tilt, stenosis or migration.There is a 3.7-degree anterior tilt.Numerous struts extended beyond the periphery of the inferior vena cava, with the longest extended 12 mm beyond the inferior vena cava wall.A fractured strut component was identified within the right-sided retroperitoneal space anterior to the ureter.The expected 3 struts at the 6 o'clock position were not visualized.Therefore, the investigation is confirmed for filter limb detachment and perforation of inferior vena cava (ivc).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 unknown medical complication.At some time post filter deployment, a bilateral lower extremity angiography revealed that the right lateral strut fractured, numerous struts extended beyond the periphery of the inferior vena cava wall and a fractured strut component was identified within the right-sided retroperitoneal space anterior to the ureter.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.

• Brand Name: G2 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: 11972457
• MDR Text Key: 255598347
• Report Number: 2020394-2021-80486
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN G2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• 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 Weight: 78