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); Thrombus (2101)

Event Date 01/21/2013

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Medical records review: the patient with a life-threatening massive pulmonary embolus had a vena cava filter deployed along with catheter directed thrombolysis and mechanical thrombectomy.Additional consult, approximately six years later, noted progressive shortness of breath/dyspnea and chest pain.The patient was admitted for anticoagulation due to acute segmental pulmonary emboli in the right lower lobe and sub segmental in the left lower lobe as seen on chest ct.No further information is noted regarding the patient¿s current status.Investigation summary: the device was not returned for evaluation and images were not provided for review.However, medical records were provided and reviewed.Approximately six years post filter deployment, ct scan demonstrated acute segmental pulmonary emboli in the right lower lobe and sub segmental in the left lower lobe.Therefore, based on the provided medical records, it can be confirmed that the patient had pe after filter implantation.The investigation, however, is inconclusive for any alleged deficiency with the filter.The origin of the pe and the relationship to the filter has not been established in the provided medical records.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 deployed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the patient experienced a pulmonary embolism.The current patient status is unknown.

Manufacturer Narrative

H10: manufacturing review: the 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 three years seven months post filter deployment, computed tomography revealed a small amount of thrombus in the upper part of the filter as well as a minimal amount of thrombus extended into the inferior vena cava above the filter for approximately 1 cm.Approximately ten months later, patient presented with abdominal pain and chest pain.Approximately one year and four months later, computed tomography revealed multiple right lower lobe segment and left lower lobe segmental pulmonary emboli.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 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.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 deployed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the patient was diagnosed with pulmonary embolism.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current patient status 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
• MDR Report Key: 7127751
• MDR Text Key: 95167896
• Report Number: 2020394-2017-01765
• 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: 08/06/2020

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 Catalogue Number: RF310F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANCEF, OXYCONTIN AND PERCOCET; WARFARIN, LOVENOX, COUMADIN
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 58 YR