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

Catalog Number RF310F

Device Problem Obstruction of Flow (2423)

Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)

Event Date 09/29/2015

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

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 and in conjunction with trauma situation/motor vehicle accident.Approximately eight years and six months post filter deployment, a computed tomography (ct) scan revealed that the filter occluded, the patient reportedly diagnosed with pulmonary embolism post implant and thrombus above the filter.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.

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 and in conjunction with trauma situation/motor vehicle accident.Approximately eight years and six months post filter deployment, a computed tomography (ct) scan revealed that the filter occluded, the patient reportedly diagnosed with pulmonary embolism post implant and thrombus above the filter.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.

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately two weeks later, abdomen 1 view showed inferior vena cava filter stable.After eight years and five months, the patient presented with chest pain and lower back pain.A computerized tomography chest and abdominal/pelvis which showed that a segmental pulmonary embolus in the right lower lobe pulmonary artery.An inferior vena cava filter was present.There was a small hypodensity just superior to the tip of the inferior vena cava filter which might represent thrombus.Occlusive thrombus in the inferior vena cava extending from the inferior vena cava filter at the level of the l2 vertebral body into bilateral common, external iliac and common femoral veins.After three weeks, computerized tomography chest and abdominal/pelvis which showed that occlusive thrombus in the inferior vena cava extending from the inferior vena cava filter at the level of the l2 vertebral body into bilateral common, external iliac and common femoral veins.No evidence of pulmonary embolism through the level of the proximal segmental pulmonary arteries.After one month, a venogram was performed which demonstrated patent left femoral vein to mid-thigh with proximal thigh iliac occlusive venous diseased.On the right side, the iliofemoral segment was occluded in entirety along with iliac vein and caval occlusion with thrombosed filter.Therefore, the investigation is confirmed for alleged filter occlusion.Additionally, it can be confirmed that the patient experienced pulmonary embolism and thrombus above the filter post deployment.However, the relationship to the filter is unknown.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.Section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: G2 FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11676811
• MDR Text Key: 249203642
• Report Number: 2020394-2021-80305
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K062887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF310F
• Device Lot Number: GFQK3518
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APIXABAN, DAPAGLIFLOZIN, ERGOCALCIFEROL; APIXABAN, DAPAGLIFLOZIN, ERGOCALCIFEROL; ATROVENT, DILTIAZEM, HYDROCHLOROTHIAZIDE; ATROVENT, DILTIAZEM, HYDROCHLOROTHIAZIDE; IMIPENEM, TIMENTIN, VANCOMYCIN, ALBUTEROL; IMIPENEM, TIMENTIN, VANCOMYCIN, ALBUTEROL; LISINOPRIL, METFORMIN, QUETIAPINE, TIZANIDINE; LISINOPRIL, METFORMIN, QUETIAPINE, TIZANIDINE; LOPRESSOR, ZANTAC, SENNA, PRIMAXIN, ASPIRIN; LOPRESSOR, ZANTAC, SENNA, PRIMAXIN, ASPIRIN; SIMVASTATIN, CLONAZEPAM, DIAZEPAM, ESZOPICLONE; SIMVASTATIN, CLONAZEPAM, DIAZEPAM, ESZOPICLONE; ZONISAMIDE, CEPHALEXIN; ZONISAMIDE, CEPHALEXIN
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 67 YR
• Patient Weight: 103