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); Thrombosis (2100); Thrombus (2101); Thrombosis/Thrombus (4440)

Event Date 08/19/2010

Event Type  Injury  

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.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 history of deep venous thrombosis and pulmonary embolus was scheduled for filter placement.Informed consent was signed and the patient was prepped and draped in sterile fashion.The right femoral vein was accessed and an ivc filter was deployed just below the level of the renal veins.The patient was hemodynamically stable at the conclusion of the procedure.Approximately eight months post filter deployment, the patient had a ct arteriogram performed to evaluate the inferior vena cava.The common iliac veins and inferior vena cava appeared to be hypodense, enlarged and likely thrombosed up to the location of the ivc filter.The following day, the patient was scheduled for thrombolytic therapy.Access was gained in the right popliteal vein and contrast injection demonstrated thrombus within the popliteal vein.A catheter was advanced to the common femoral vein, but could not be advanced centrally due to complete occlusion of the common femoral vein.Access was then gained in the left popliteal vein and contrast injection demonstrated a thrombosed popliteal vein and the catheter and guidewire could not be advanced.Due to an inability to gain access to the inferior vena cava from the lower extremities, the right internal jugular vein was evaluated and appeared patent.Access was gained in the internal jugular vein and multiple unsuccessful attempts were made to advance a catheter to the distal inferior vena cava as there was complete occlusion at the superior aspect of the filter.Due to the inability to advance a guidewire and catheter into the inferior vena cava, thrombolytic therapy was not attempted.The patient tolerated the procedure well.Approximately six years five months post filter deployment, the patient with severe venous thromboembolic disease and bilateral post-thrombotic syndrome was scheduled for filter retrieval as well as bilateral endovascular reconstruction of the iliocaval and femoral systems.The inferior vena cava was occluded secondary to the inferior vena cava filter and had bilateral iliocaval occlusion.The patient was placed in supine position and the right neck and bilateral groins were prepped and draped in sterile fashion.Bilateral femoral veins were accessed and venograms demonstrated femoral vein obstruction with femoral vein occlusion.The right internal jugular vein was accessed and the filter was removed in its entirety without difficulty.The left and right femoral veins were recanalized with 0.035 wires and a 5 french triforce system.There was difficulty accessing the inferior vena cava from femoral vein access due to the occlusion.Jugular access was used to snare the wires from the iliac veins to have bilateral through and through access into the inferior vena cava.Serial balloon dilatation was performed bilaterally followed by a stenting procedure.Post-dilatation was used bilaterally throughout the entire length of the stented segment.Completion imaging demonstrated excellent deployment of the stents with good apposition and demonstrated excellent flow through the femoral and iliocaval systems bilaterally.All devices were removed and compression was held at all access sites followed by placement of pressure dressings.The patient was taken to the recovery room in stable condition.There were no complications.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 deployed successfully.Approximately seven months post filter deployment, the distal inferior cava was found to be completely occluded up to the superior aspect of the filter.Approximately six years and five months post filter, the filter was retrieved without difficulties.Based on the medical records, the investigation can be confirmed for occlusion within the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: potential complications: - caval thrombosis/occlusion 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.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 that a vena cava filter was deployed successfully, the reason for the filter deployment was not provided.No alleged deficiency with the device was reported.No other information regarding this event was received.Patient status was not provided.New information received: medical records were received and reviewed.Approximately eight months post filter deployment, ct arteriogram performed to evaluate the inferior vena cava demonstrated iliac and ivc thrombosis.The following day the patient was scheduled for thrombolytic therapy.Multiple attempts to access the inferior vena cava were unsuccessful due to total occlusion at the superior aspect of the filter; therefore, thrombolytic therapy was not attempted.Approximately six years five months post filter deployment, the patient presented for filter retrieval and bilateral endovascular reconstruction of the iliocaval and femoral systems.The right internal jugular vein was accessed and the filter was removed in its entirety without difficulty.Balloon dilatation followed by bilateral stenting was performed.Completion imaging demonstrated excellent stent positioning with excellent flow through the femoral and iliocaval systems bilaterally.All devices were removed and dressings were placed.The patient was taken to the recovery room in stable condition, there were no complications.No additional information 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.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately seven months later, the patient was admitted in hospital and diagnosed with bilateral lower extremity deep vein thrombosis that have been chronic with an inferior vena cava filter occlusion.On the next day, inferior venacavogram was performed.Under sonographic guidance, utilizing a micropuncture system, the right internal jugular vein was punctured.Via manipulation of catheters and guide wires, a catheter was inserted into the inferior vena cava to the level of previously placed inferior vena caval filter.Multiple attempts to advance a catheter distal to the inferior vena cava were unsuccessful as there was complete occlusion at the level of the superior aspect of the filter.Thrombus was noted in the inferior vena cava at the level of the filter.After four years, computed tomography of abdomen and pelvis with intravenous contrast showed that there was an inferior vena cava filter in place.The inferior vena cava at and below the level of the inferior vena cava filter was collapsed.There were prominent varices in the anterior abdominal wall.Ultrasound showed that the inferior vena cava was occluded along with bilateral deep venous thrombosis.After three weeks, it was reported that the patient might have occluded inferior vena cava.After one-year, computed tomography of abdomen and pelvis with intravenous contrast was performed due to abdominal pain and result showed that there was an inferior vena cava filter in place.The inferior vena cava at and below the level of the inferior vena cava filter was collapsed.There were prominent varices in the anterior abdominal wall.After eight months, abdomen 1 view demonstrated that an inferior vena cava filter was in place.Therefore, the investigation is confirmed for alleged filter occlusion.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.Based on 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: 10/2012.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 that approximately eight months post filter deployment, computed tomography arteriogram performed to evaluate the inferior vena cava demonstrated iliac and inferior vena cava thrombosis.The following day the patient was scheduled for thrombolytic therapy.Multiple attempts to access the inferior vena cava were unsuccessful due to total occlusion at the superior aspect of the filter; therefore, thrombolytic therapy was not attempted.Approximately six years and five months post filter deployment, the patient presented for filter retrieval and bilateral endovascular reconstruction of the iliocaval and femoral systems.The right internal jugular vein was accessed and the filter was removed in its entirety without difficulty.Balloon dilatation followed by bilateral stenting was performed.Completion imaging demonstrated excellent stent positioning with excellent flow through the femoral and iliocaval systems bilaterally.All devices were removed and dressings were placed.The patient was taken to the recovery room in stable condition, there were no complications.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
• MDR Report Key: 6132979
• MDR Text Key: 61057259
• Report Number: 2020394-2016-01116
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K082305
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: RF400F
• Device Lot Number: GFTI2502
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTICOAGULATION; ANTICOAGULATION, LOVENOX, COUMADIN, FOLIC ACID; ATIVAN, LITHIUM, GABAPENTIN, SEROQUEL; CYCLOBENZAPRINE, DIVALPROEX; FAMOTIDINE, AND MELOXICAM; OXYCODONE, XANAX, ACETAMINOPHEN; RESTORIL, ZOFRAN, FOLIC ACID, MULTIVITAMIN; THIAMINE, FRAGMIN, VICODIN; TRAZODONE, TEMAZEPAM, XARELTO; ZOLPIDEM, ATORVASTATIN; ANTICOAGULATION
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 110