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

Catalog Number RF310F

Device Problems Obstruction of Flow (2423); Extrusion (2934); Positioning Problem (3009); Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); No Consequences Or Impact To Patient (2199); Thrombosis/Thrombus (4440)

Event Date 04/05/2009

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for 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 approximately six years ten months post vena cava filter deployment a ct scan demonstrated the ivc filter penetrating beyond the ivc lumen, including one anterior limb impressing upon the second portion of the duodenum.The status of the patient is unknown.

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for 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.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.

Event Description

It was reported through the litigation process that approximately six years ten months post vena cava filter deployment a ct scan demonstrated the ivc filter penetrating beyond the ivc lumen, including one anterior limb impressing upon the second portion of the duodenum.The status of the patient is unknown.

Event Description

It was reported through the litigation process that approximately six years ten months post vena cava filter deployment a ct scan demonstrated the ivc filter penetrating beyond the ivc lumen, including one anterior limb impressing upon the second portion of the duodenum.The status of the patient is unknown.New information: 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.At some time post filter deployment, it was alleged that the filter struts perforated.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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were not provided for review.Therefore, the investigation is inconclusive for filter limb perforation of ivc wall 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.(expiry date: 03/2012).

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.Bard g2 filter was deployed at the l1-l2 level for a patient with deep vein thrombosis.Patient had a slight tilt to the right in the upper part of the filter.Post filter deployment vena cavogram showed the filter to be well deployed in the inferior vena cava at the l1 level and the vein tilted off to the right slightly at that point, but the main channel was completely covered.Approximately, nine days of post deployment, patient presented with the complaints of right lower quadrant abdominal pain.A computed tomography of abdomen and pelvis was performed which showed inferior vena cava filter was noted at the l1-l2 level.Around, two years six months later a computed tomography angiogram of chest was performed for shortness of breath.The study showed that extensive bilateral pulmonary emboli involving anterior segmental and sub segmental branches right upper lobe, origin of the right lower lobe pulmonary artery and right posterior basal segmental branches of right lower lobar pulmonary artery.Additional pulmonary emboli in lateral and posterior basal segmental and sub segmental branches left lower lobe pulmonary artery and anterior and posterior branches of left upper lobe pulmonary artery.On the next day, a computed tomography of abdomen and pelvis was performed which showed infra renal inferior vena cava filter was noted, which was slightly tilted to the right with some of the medial limbs projecting beyond the inferior vena cava lumen into the adjacent soft tissue.Around, four years three months later, a computed tomography angiogram of chest was performed for chest pain.The study showed that no evidence of pulmonary embolism.After, three days, a computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that inferior vena cava filter was in place at the level of the renal veins, with protrusion of multiple limbs of the filter beyond the lumen of the inferior vena cava.One limb impresses upon the second portion of the duodenum, which could conceivably be a generator of abdominal pain.Around, one year and eight months later, patient was diagnosed with clogged inferior vena cava filter and underwent thrombolysis of filter.Attempted to remove the filter, but due to the presence of ileocaval thrombus, rescheduled after continued anticoagulation.Around three months and twenty-six days later, patient presented for filter removal.Through the right internal jugular vein approach, a wire was passed into the inferior vena cava.A venogram was performed demonstrating no clot in the right iliac vein but persistent clot at the apex of the inferior vena cava filter.Compared to the prior study, the amount of thrombus burden within the cava and trapped in the filter has significantly decreased.However, these remains concern for embolization to the lungs and the procedure was terminated.Therefor the investigation is confirmed for perforation of the inferior vena cava (ivc), positioning issue and occlusion within the inferior vena cava filter.Additionally, it can be confirmed that the patient experienced 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: 03/2012),g2,g3,h6(device,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.Approximately six years and ten months post vena cava filter deployment, a computed tomography scan demonstrated that the inferior vena cava filter penetrating beyond the inferior vena cava lumen, including one anterior limb impressing upon the second portion of the duodenum.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.

• 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: 7636052
• MDR Text Key: 112297974
• Report Number: 2020394-2018-00971
• 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,Followup,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• 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: GFTB0039
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HYDROMORPHONE, ONDANSETRON AND DIAZEPAM; LISINOPRIL, COUMADIN AND TRAMADOL; OXYCODONE-ACETAMINOPHEN AND DULOXETINE
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 30 YR
• Patient Weight: 89