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

Catalog Number RF310F

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

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

Event Date 01/12/2007

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/pulmonary embolism.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with pulmonary embolism post implant; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.On the same day of deployment, computed tomography arteriogram of chest was performed which showed large pulmonary embolism in the right lower lobe pulmonary artery which was near occlusive extending down into posterior segmental branches.Around, six months and one week later, computed tomography angiography of abdomen, pelvis, abdomen with and without contrast was performed which showed there was an inferior vena cava filter with clot above and below the filter.The entire inferior vena cava was clotted, and there was enhancement of the wall and edematous changes surrounding the inferior vena cava.On the next day, computed tomography of abdomen and pelvis without contrast was performed which revealed an inferior vena cava filter was in place.The inferior vena cava and bilateral common iliac veins are thrombosed below the filter, and the inferior vena cava and tributary major veins are enlarged, which can be seen in acute thrombosis; this also raises the possibility of thrombophlebitis.Around two weeks later, computed tomography of chest, abdomen and pelvis was performed which showed there was thrombus completely filling the inferior vena cava at the level of the filter, the filter tip was just below the level of the renal veins.Also, a small partially occlusive thrombus continues above the filter, to the level of the renal veins, but the renal veins are patent.After, three days, interventional radiology transcatheter inferior thrombolysis was performed which showed there was also thrombosis of the inferior vena cava.Filling defects are identified within the inferior vena cava filter as well as filling defects just cephalad to the filter.On the next day, interventional radiology transcatheter inferior thrombolysis was performed which showed filling defects were identified in the inferior vena cava above the filter which are not occlusive.After, seven days, radiology of chest posteroanterior and lateral view was performed which showed inferior vena cava filter was partially imaged at the inferior aspect of the images.Around, seven years and five months later, the patient was diagnosed with pulmonary embolism.Around, eleven months later, computed tomography angiography of chest was performed which showed there are a few filling defects in the right lower lobe pulmonary arteries, consistent with pulmonary emboli.These were not seen on the most recent study eight days ago and are felt to represent acute pulmonary emboli, with small clot burden.Around, four months later, digital subtraction venography was performed which showed approximately fifty percent infrarenal inferior vena cava narrowing with penetration of all of the visualized limbs of the inferior vena cava filter.There were no device deficiencies identified within the medical records.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Additionally, it can be confirmed that the patient experienced pulmonary embolism (pe) post deployment and thrombus above the filter post deployment.However, the relationship to the filter is unknown.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.H10: d4(expiry date: 08/2008), g3, h6(method) h11: h6(result, conclusion) h11: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.

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.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with pulmonary embolism post implant; however, the current status of the patient is unknown.

• 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
• 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: 12776864
• MDR Text Key: 280509321
• Report Number: 2020394-2021-80804
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062887
• 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,Followup
• Report Date: 11/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• 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: GFPH3919
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2005
• 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, LOVENOX, ARIXTRA, METOPROLOL; COUMADIN, LOVENOX, ARIXTRA, METOPROLOL; LOPRESSOR, IRON SULFATE AND PREVACID; LOPRESSOR, IRON SULFATE AND PREVACID
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Race: Black Or African American