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

Catalog Number RF400F

Device Problems Obstruction of Flow (2423); Positioning Problem (3009)

Patient Problems Thrombus (2101); Thrombosis/Thrombus (4440)

Event Date 10/27/2009

Event Type  Injury  

Manufacturer Narrative

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.There was a minimal angulation of less 10degrees was noted.Approximately two years post filter deployment, ct revealed iliocaval occlusion up to the level of the filter.Venogram was performed which showed occlusion of the distal ivc with thrombus up to and beyond the filter, and thrombus in the iliac vein on the left as well.A large reliant balloon was placed above the filter and inflated to prevent distal embolization with intervention.Eventually, thrombectomy was performed.Approximately five years later, patient was scheduled for filter retrieval.There was no evidence of thrombus noted.The filter was retrieved successfully using sheath and snare.Therefore, the investigation is confirmed for occlusion of the ivc filter and positioning issue.Additionally, it can be confirmed that the patient experienced 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.(expiry date: 07/2012).

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.At some time post filter deployment, it was alleged that iliocaval occlusion of the filter.The device was removed percutaneously.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.The medical records allege bard g2x filter was deployed without difficulty.There was minimal, less than 10 degrees, angulation present.Follow-up venogram demonstrated the filter to be in good position.There was good flow through the filter.There was no evidence of extravasation.There was no thrombus.Approximately one year and two months later, computed tomography angiogram of chest was performed, and an inferior vena cava filter was present.There was some clot within the inferior vena cava filter.Subtle diffuse heterogeneity throughout the venous structures below the level of the inferior vena cava filter were seen.After two days, venogram performed which showed occlusion of the distal vena cava with thrombus up to and beyond the inferior vena cava filter, and thrombus in the iliac vein on the left as well.The catheter was then passed above the filter, and venogram performed which showed the inferior vena cava to be patent beyond the filter and prompt flow into the heart.A wire was passed through the catheter beyond the filter.A wholey wire and glide catheter were used to cross the iliocaval occlusion, accessing above the filter.A large reliant balloon was placed above the filter and inflated to prevent distal embolization with intervention.10 mg of tpa were laced on the left iliac vein and distal inferior vena cava using the dvx angiojet catheter.After 15 minutes, 200 ml of thrombectomy were performed.Post venogram was performed which showed improved flow on the left side with residual thrombus.Another 100 ml of thrombectomy were performed.Venogram from the right side showed residual thrombus in the iliac veins, but improved flow.The distal cava appeared to fill without significant residual thrombus.Venogram from the left side showed residual thrombus in the iliac veins, but the distal cava and filter are widely patent now without thrombus.After five years and three months, acute embolism, and thrombosis of unspecified deep veins of unspecified lower extremity was noted.Removal of old filter and replacement with a greenfield filter was planned.After ten days, right internal jugular vein was accessed and a venacavogram was performed demonstrating a patent vena cava.There was a vena cava filter in place.There was no evidence of thrombus.A 7-french sheath was passed and then a snare was passed, the retrievable filter was snared, filter was decompressed and removed without difficulty.Then it was elected to proceed with placement of a permanent filter.A greenfield filter sheath was advanced over the wire into the mid inferior vena cava and deployed a greenfield filter at l2, l3 vertebral disk space.The filter deployed appropriately.Completion venogram demonstrates good placement of the filter, no extravasation and no evidence of thrombus.Then the sheath was removed and manual pressure was held until hemostatic.At the end of the procedure, the patient was stable and tolerated it well.Therefore, the investigation is confirmed for filter occlusion and positioning issue.Additionally, it can be confirmed that the patient experienced 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: b6, b7, d4(expiry date: 07/2012), g3, h6(method, conclusion).H11: h6(result).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.At some time post filter deployment, it was alleged that iliocaval occlusion of the filter.The device was removed percutaneously.The current status of the patient is unknown.

• Brand Name: G2 X 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: 9479026
• MDR Text Key: 174559564
• Report Number: 2020394-2019-05636
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082305
• 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: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF400F
• Device Lot Number: GFTE3391
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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): Other
• Patient Age: 67 YR
• Patient Sex: Male