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

Catalog Number RF400F

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423)

Patient Problems Occlusion (1984); Swelling (2091); Thrombosis (2100); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 04/12/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: the patient with lower extremity dvts was indicated for vena cava filter placement.Access was gained to the right common femoral vein and a venacavagram demonstrated a vena cava diameter less than 23 mm with no anomalies and no clot.The filter was successfully deployed just below the lowest renal vein without incident.A post placement radiograph demonstrated good position of the filter.Compression was applied to the access site until hemostasis was achieved.Approximately six years post filter deployment, the patient presented to the hospital with severe right lower extremity swelling.A ct scan demonstrated complete thrombosis from the ivc filter from the infrarenal ivc down the right leg and just to the left common iliac vein.It was recommended that catheters be placed and thrombolysis performed.The left common femoral vein was accessed and a cavogram demonstrated complete occlusion of the left common iliac vein as well as the inferior vena cava with reconstitution of the renal vena cava.An infusing catheter was placed from the ivc filter down into the left common iliac system.The popliteal veins were accessed and a right venogram was performed showing some nonocclusive thrombus of the femoral vein.A venacavagram was performed from the external iliac vein and showed complete occlusion of the vena cava system as well as the iliacs.A wire was transversed into the ivc filter and another lysis catheter was placed from below the treatment zone from the left side into the right common iliac system.The rate of infusion was set and the procedure was completed.The patient tolerated the procedure well without complications.The plan was to monitor the patient overnight and possibly intervene with more treatment the following day.Image/photo review: as medical images were not provided, a review could not be performed.Conclusion: the device was not returned.Images were not provided.Medical records were provided and reviewed.A vena cava filter was successfully deployed.Six years post filter deployment a ct scan demonstrated complete thrombosis from the ivc filter from the infrarenal ivc down the right leg and just to the left common iliac vein.Based on the medical records the investigation can be confirmed for occlusion within the device.Based upon the available information the definitive root cause for this event is unknown.Labeling review: the current ifu (instructions for use) states: warnings: note: it is possible that complications such as those described in the "warnings", "precautions," or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.Potential complications: - caval thrombosis/occlusion.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

Medical records were received and reviewed.Approximately six years post vena cava filter deployment indicated for lower extremity dvt, the patient presented with right lower extremity swelling.Imaging demonstrated complete thrombosis of the vena cava from the filter to the iliac veins.Subsequent chemical thrombolysis of the iliocaval system was performed.The patient tolerated the procedure well without complications.The plan was to monitor the patient and possibly intervene with more treatment the following day.No additional information surrounding this event was provided in the medical records received.

Manufacturer Narrative

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.This is the only event reported to date for this lot number and failure mode.Medical records review: the patient with lower extremity dvts was indicated for vena cava filter placement.Access was gained to the right common femoral vein and a venacavagram demonstrated a vena cava diameter less than 23 mm with no anomalies and no clot.The filter was successfully deployed just below the lowest renal vein without incident.A post placement radiograph demonstrated good position of the filter.Compression was applied to the access site until hemostasis was achieved.Approximately six years post filter deployment, the patient presented to the hospital with severe right lower extremity swelling.A ct scan demonstrated complete thrombosis from the ivc filter from the infrarenal ivc down the right leg and just to the left common iliac vein.It was recommended that catheters be placed and thrombolysis performed.The left common femoral vein was accessed and a cavogram demonstrated complete occlusion of the left common iliac vein as well as the inferior vena cava with reconstitution of the renal vena cava.An infusing catheter was placed from the ivc filter down into the left common iliac system.The popliteal veins were accessed and a right venogram was performed showing some nonocclusive thrombus of the femoral vein.A venacavagram was performed from the external iliac vein and showed complete occlusion of the vena cava system as well as the iliacs.A wire was transversed into the ivc filter and another lysis catheter was placed from below the treatment zone from the left side into the right common iliac system.The rate of infusion was set and the procedure was completed.The patient tolerated the procedure well without complications.The plan was to monitor the patient overnight and possibly intervene with more treatment the following day.Investigation summary: the device was not returned.Images were not provided.Medical records were provided and reviewed.A vena cava filter was successfully deployed.Six years post filter deployment a ct scan demonstrated complete thrombosis from the ivc filter from the infrarenal ivc down the right leg and just to the left common iliac vein.Based on the medical records the investigation can be confirmed for occlusion within the device.Based upon the available information the definitive root cause for this event is unknown.Labeling review: the current ifu (instructions for use) states: warnings: note: it is possible that complications such as those described in the "warnings", "precautions," or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.Potential complications: caval thrombosis/occlusion.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: 04/2012), (manufacturing date: 08/2009).

Event Description

Medical records were received and reviewed.Approximately six years post vena cava filter deployment indicated for lower extremity dvt, the patient presented with right lower extremity swelling.Imaging demonstrated complete thrombosis of the vena cava from the filter to the iliac veins.Subsequent chemical thrombolysis of the ileocaval system was performed.The patient tolerated the procedure well without complications.The plan was to monitor the patient and possibly intervene with more treatment the following day.No additional information surrounding this event was provided in the medical records received.

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 five years and nine months of post filter implantation, a computed tomography of abdomen and pelvis was performed, and the study showed occlusive thrombosis of inferior vena cava inferior to the filter and mild extension of thrombus superior to the filter.After, three days, a venogram was performed for inferior vena cava thrombosis and oasis catheter placement.An initial indication was provided which mentioned that a computed tomographic study had performed which showed complete thrombosis from the inferior vena cava filter from the infrarenal inferior vena cava, down the right leg and just to the left common iliac vein on the left.So, it was recommended to place the catheter and perform a thrombolysis.During thrombolysis, a cavogram was shot which demonstrated complete occlusion of the left common iliac vein as well as inferior vena cava with reconstruction of renal vena cava.Then, another venogram was shot which demonstrated complete occlusion of vena cava system from external iliac vein as well as iliac.On the next day, a venogram was performed for inferior vena cava thrombosis and the study showed that there still complete occlusion of the common iliac vein through the inferior vena cava and then the clot resolved right at the confluence of the renal veins, where the inferior vena cava filter was.However, it was believed for an optimal result lysis catheter of the diseased left overnight and the filter removal with stent placement.However, the patient does not tolerate any thrombolysis overnight and there was still some small clot burden even though recanalize the inferior vena cava and the filter was the placed.Therefore, the investigation is confirmed for occlusion of the inferior vena cava (ivc).Based on the available information, the definitive root cause is unknown.Labeling review: the current instructions for use states: warnings: note: it is possible that complications such as those described in the "warnings", "precautions," or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.Potential complications: - caval thrombosis/occlusion 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: b5, b6, b7, d4 (expiry date: 04/2012), d10, 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 deep vein thrombosis/pulmonary embolism.Approximately six years post vena cava filter deployment indicated for lower extremity deep vein thrombosis, the patient presented with right lower extremity swelling.Imaging demonstrated complete thrombosis of the vena cava from the filter to the iliac veins.Subsequent chemical thrombolysis of the ileo caval system was performed.The device has not been removed and there were no reported attempts made to retrieve the filter the current status of the patient was 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: 6263531
• MDR Text Key: 65258819
• Report Number: 2020394-2017-00008
• 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,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: GFTC4541
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/19/2017
• Supplement Dates Manufacturer Received: 01/14/2019; 03/04/2022
• Supplement Dates FDA Received: 02/06/2019; 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2009
• 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: LOVENOX; LOVENOX; LOVENOX, COUMADIN, KEPPRA, OXYCODONE; PROTONIX AND MULTIVITAMIN; LOVENOX
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White