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

Catalog Number RF320J

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

Patient Problem Pulmonary Embolism (1498)

Event Date 06/09/2009

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.There was no specific deficiency alleged in the provided medical records.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: potential complications: procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.Possible complications include, but are not limited to, the following: - acute or recurrent pulmonary embolism.This has been reported despite filter usage.It is not known if thrombi passed through the filter, or originated from superior or collateral vessels.The information provided by bard 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 bard.

Event Description

It was reported through the litigation process that a vena cava filter was placed after being diagnosed with iliac and inferior vena cava clots.Some time post filter deployment (date not provided), the patient allegedly experienced recurrent pulmonary embolisms and thrombosis.Patient status was not reported.

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.Approximately one month later, a computed tomography of abdomen was performed for pelvic abscess.The study showed that a suprarenal inferior vena cava filter was noted.Also, the inferior vena cava below the filter and the common iliac arteries were filled with thrombus and the thrombus extended to the level of the common femoral veins bilaterally.After one year and nine months, a computed tomography of chest was performed for intermittent chest pain related to frequent pulmonary embolisms status post filter implantation.The study showed that there was a mass in the left lower lobe that had increased in size from 1.8 x 1.8 cm till present day to 4.5 x 3.3 x 2.7 cm and there were also multiple segmental pulmonary emboli seen.After two days, a computed tomography of chest was performed for pulmonary embolism.The study demonstrated new onset of pulmonary embolism and an enlarged pulmonary lesion related with pulmonary pseudoaneurysm.After two years and six months, a computed tomography of abdomen and pelvis was performed for right groin mass and right lower quadrant pain.The study showed that there was a suprarenal inferior vena cava filter present.After one month, the patient reported of chest pain and was examined.During the assessment related to deep vein thrombosis/pulmonary embolism, it was observed that the patient was tachycardic which could be secondary to small pulmonary embolism and the patient was already being anticoagulated and has a thrombosed 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 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.H10: b7, d4(expiry date: 10/2009), g3.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 after being diagnosed with iliac and inferior vena cava clots.Some time post filter deployment (date not provided), the patient allegedly experienced recurrent pulmonary embolisms and thrombosis.Patient status was not reported.

• Brand Name: G2 FILTER SYSTEM - JUGULAR
• 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: 7127740
• MDR Text Key: 95168843
• Report Number: 2020394-2017-01767
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052578
• 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: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2009
• Device Catalogue Number: RF320J
• Device Lot Number: GFQI4013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2007
• 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): Life Threatening
• Patient Age: 24 YR
• Patient Sex: Female