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

Catalog Number RF310F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Extrusion (2934)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Thrombosis/Thrombus (4440)

Event Date 05/14/2012

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 history of massive pulmonary embolism had a retrievable inferior vena cava (ivc) filter deployed within the infrarenal ivc at the approximate level of l2.There were no complications.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 for tilt and perforation 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: 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.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 in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism and in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter struts had perforated into the organs and the filter tilted and was embedded in wall of the ivc.The patient experienced a pulmonary embolism post filter implant.The device has not been removed and there were no reported attempts made to retrieve the filter.The status of the patient is unknown.

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 history of massive pulmonary embolism had a retrievable inferior vena cava (ivc) filter deployed within the infrarenal ivc at the approximate level of l2.There were no complications.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 for tilt, perforation, and pe 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: 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.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 in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism and in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter struts had perforated into the organs and the filter tilted and was embedded in wall of the ivc.The patient experienced a pulmonary embolism post filter implant.The device has not been removed and there were no reported attempts made to retrieve the filter.The status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a 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.Bard denali inferior vena cava filter was deployed in the infra-renal location at the level of l2 without evidence of angulation or embolization.Approximately, three years and six months of post-deployment, inferior vena cavogram was performed which showed through the right internal jugular vein approach, a bard suprarenal unknown filter was deployed successfully in an infra renal position for a patient with free-floating clot above the inferior vena cava filter.Around, one year and seven months later, computed tomography angiography of chest was performed which showed a large embolus was in the periphery of the left pulmonary artery also extending into segmental branches.Around, one year and eight months later, computed tomography of chest with contrast was performed which showed extensive pulmonary embolism specially in the right lower lobe pulmonary artery branches as well as in the left upper lobe and right upper lobe pulmonary artery branches.Around, nine months later, computed tomography of abdomen and pelvis with and without contrast was performed which showed filter below the renal veins.The filter was tilted posteriorly and to the right with its cone lying on the anterior inferior vena cava wall.The legs of the filter penetrate the inferior vena cava wall into the pericaval/mesenteric fat.One of the legs penetrates the periosteum of the l2 vertebra.Around, one year and nine months later, the patient experienced abdominal pain, computed tomography of abdomen and pelvis with contrast was performed which showed inferior vena cava filter caudal to the level of the renal veins with thrombus extending outside the confines of the inferior vena cava.Therefore, the investigation is confirmed perforation of the inferior vena cava(ivc), and filter tilt.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.H10: b2,b6,b7,g3,h6 (patient).H11: g1,h6(device, method, 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 and in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter struts had perforated into the organs and the filter tilted and was embedded in wall of the ivc.The patient was diagnosed with pulmonary embolism post filter implant.The device has not been removed and there were no reported attempts made to retrieve the filter.The 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: 7580688
• MDR Text Key: 110445785
• Report Number: 2020394-2018-00819
• 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,Followup
• Report Date: 11/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• 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: 11/01/2021
• 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
• Treatment: ALBUTEROL, METOPROLOL TARTRATE, FAMOTIDINE; AZITHROMYCIN, CEFDINIR AND FUROSEMIDE; LEVOFLOXACIN, SPIRONOLACTONE, PREDNISONE
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 60 YR
• Patient Sex: Female