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

Catalog Number RF400J

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2014

Event Type  malfunction  

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 renal vein thrombosis was transferred from the (b)(6) medical center for filter placement.Informed consent was obtained and the patient was placed in supine position on the angiographic table.The right groin was prepped and draped in sterile fashion.The right common femoral vein was accessed under ultrasound guidance and a j-wire was advanced into the distal inferior vena cava followed by placement of a 4 french sheath.Medical grade carbon dioxide was administered through the sheath and an inferior venacavagram was performed which demonstrated a large filling defect noted in the left juxtarenal inferior vena cava.Carbon dioxide gas flowed through the vena cava beyond this level.There was a flash filling of a right hepatic vein, and the defect represented a thrombus identified at the t12 vertebral body level.The right side of the neck was prepped and draped in sterile fashion.The right internal jugular vein was accessed under ultrasound guidance and a guidewire was advanced into the superior vena cava followed by placement of a 4 french sheath.The sheath was advanced over the guidewire into the inferior vena cava at the level of the inferior vena cava thrombus.Carbon dioxide was administered via the femoral vein and an inferior renal cavogram was performed.The filter was advanced through the internal jugular vein sheath and successfully deployed above the level of the thrombus.The apex of the filter was identified projecting at the superior endplate of t11 vertebral body.Completion venacavagram performed via the femoral vein demonstrated the filter to be cephalad to the inferior vena cava thrombus.An additional fitting defect was seen within the legs of the filter.The deployment device and sheaths were removed and hemostasis was achieved.The patient tolerated the procedure well and was discharged from the department in stable condition.The patient was transferred back to the va medical center for continued treatment two days post filter deployment.Approximately five years nine months post filter deployment, addendum to mr venogram reported moderate narrowing of the left renal vein near the inferior vena cava and struts of the ivc filter were seen projecting into the left renal vein.The films were reviewed with the radiologist who felt there was no need to adjust the position of the ivc filter and was referred to vascular surgery.Assessment performed by vascular surgery stated the patient's left flank pain was not related to the ivc filter as ct scan demonstrated the filter is in its place.The patient was referred to nephrology for consultation regarding flank pain.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 above thrombus.Approximately five years and nine months post filter deployment, struts of the ivc filter were seen projecting into the left renal vein.Based on the provided medical records, the investigation can be confirmed for unintended movement of the filter limbs.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings: - do not deploy the filter prior to proper positioning in the ivc, as the g2 express vena cava filter cannot be safely reloaded into the storage tube.Do not deploy the filter unless ivc has been properly measured.Never re-deploy a removed filter.Precautions: - position the filter snare hook 1cm below the lowest renal vein.Venacavography must always be performed to confirm proper implant site.Radiographs without contrast, which do not clearly show the wall of the ivc, may be misleading.- if misplacement, sub-optimal placement, or tilting of the filter occurs, consider immediate removal.Do not attempt to reposition the filter.Potential complications: - movement, migration or tilt of the filter are known complications of vena cava filters.Direction for use - implantation: - select the optimum location (for example 1cm below the lowest renal) for filter placement and measure the ivc diameter.- prior to deployment, verify the location of the filter within the sheath using fluoroscopy and confirm that the filter snare hook is 1cm below the lowest renal or is in the intended location in the inferior vena cava.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 provided.The patient status at this time is unknown.New information received: medical records were received and reviewed.The patient with history of renal vein thrombosis was scheduled for filter placement.The right common femoral vein was accessed and an inferior venacavagram with carbon dioxide demonstrated a thrombus at the t12 vertebral body.The right internal jugular vein was accessed and the filter was successfully deployed above the level of the thrombus.Completion venacavagram demonstrated the filter to be cephalad to the thrombus with additional fitting defect seen within the legs of the filter.The patient was hemodynamically stable at the conclusion of the procedure.Approximately five years nine months post filter deployment, mr venogram demonstrated narrowing of the left renal vein with filter limbs extending into the left renal vein.Films were reviewed with the radiologist who felt there was no need to adjust the position of the filter.No additional information 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.Bard filter was deployed above the level of the thrombus.The apex of the filter was identified projecting at the superior endplate of t11 vertebral body.Completion venacavagram performed via the femoral vein demonstrated the filter to be cephalad to the inferior vena cava thrombus.An additional fitting defect was seen within the legs of the filter.The deployment device and sheaths were removed and hemostasis was achieved.Approximately, five years nine months post-deployment, addendum to mr venogram reported moderate narrowing of the left renal vein near the inferior vena cava and struts of the filter were seen projecting into the left renal vein.The films were reviewed with the radiologist who felt there was no need to adjust the position of the inferior vena cava (ivc) filter and was referred to vascular surgery.Assessment performed by vascular surgery stated the patient's left flank pain was not related to the filter as computed tomography (ct) scan demonstrated the filter is in its place.The patient was referred to nephrology for consultation regarding flank pain.There were no device deficiencies identified within the medical records.Therefore, the investigation is inconclusive for unintended movement of the filter, perforation of the inferior vena cava (ivc) and filter migration 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 current instructions for use states: warnings: do not deploy the filter prior to proper positioning in the ivc, as the g2 express vena cava filter cannot be safely reloaded into the storage tube.Do not deploy the filter unless ivc has been properly measured.Never re-deploy a removed filter.Precautions: position the filter snare hook 1cm below the lowest renal vein.Venacavography must always be performed to confirm proper implant site.Radiographs without contrast, which do not clearly show the wall of the ivc, may be misleading.If misplacement, sub-optimal placement, or tilting of the filter occurs, consider immediate removal.Do not attempt to reposition the filter.Potential complications: movement, migration or tilt of the filter are known complications of vena cava filters.Direction for use implantation: select the optimum location (for example 1cm below the lowest renal) for filter placement and measure the ivc diameter.Prior to deployment, verify the location of the filter within the sheath using fluoroscopy and confirm that the filter snare hook is 1cm below the lowest renal or is in the intended location in the inferior vena cava.H10: d4(expiry date: 09/2011),g4.H11: e1(complainant mail address),h6(method and 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 in to renal vein thrombosis.The right common femoral vein was accessed and an inferior venacavagram with carbon dioxide demonstrated a thrombus at the t12 vertebral body.The right internal jugular vein was accessed and the filter was successfully deployed above the level of the thrombus.Completion venacavagram demonstrated the filter to be cephalad to the thrombus with additional fitting defect seen within the legs of the filter.The patient was hemodynamically stable at the conclusion of the procedure.Approximately five years nine months post filter deployment, mr venogram demonstrated narrowing of the left renal vein with filter limbs extending into the left renal vein it, was alleged that filter migrated and struts perforated.Films were reviewed with the radiologist who felt there was no need to adjust the position of the filter.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 EXPRESS FILTER SYSTEM - JUGULAR
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6170482
• MDR Text Key: 62384069
• Report Number: 2020394-2016-01164
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K080668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Catalogue Number: RF400J
• Device Lot Number: GFSH2162
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WARFARIN 7.5 MG DAILY; WARFARIN 7.5 MG DAILY; WARFARIN 7.5 MG DAILY
• Patient Age: 41 YR
• Patient Weight: 122