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

Catalog Number RF310F

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Abdominal Pain (1685); No Consequences Or Impact To Patient (2199)

Event Date 01/22/2013

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 had sustained serious trauma requiring long hospitalization and multiple surgeries; therefore, vena cava filter placement was indicated.The femoral vein was accessed using seldinger technique.A venacavogram demonstrated a patent ivc without abnormal anatomy.The filter was deployed in the infrarenal ivc without incident.The patient was hemodynamically stable at the conclusion of the procedure.Approximately three years six months post filter deployment, the patient presented for retrieval of the filter.Ultrasound guidance was used to access the right internal jugular vein using a micropuncture technique.A venacavogram demonstrated the filter in good position with no tilt.However, there was a detached filter limb.Multiple attempts to retrieve the filter with a cone retrieval device were unsuccessful as a 10 french sheath was unable to be advanced over the filter due to significant resistance.The decision was made to conclude the procedure.A spot film of the filter showed no change in position of the filter or the detached filter limb.All wires and catheters were removed and manual pressure was held for hemostasis.The patient tolerated the procedure well.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.Approximately three years and six months post successful filter deployment, during a schedule retrieval attempt, a venacavagram demonstrated a detached filter limb.Multiple attempts were made to retrieve the filter, however the filter could not be removed.Based on the medical records, the investigation can be confirmed for a detached filter limb and difficulties removing the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: - filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.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 provided.The patient status at this time is unknown.New information received: medical records were received and reviewed.Approximately three years six months post vena cava filter deployment, the patient presented for retrieval of the filter.Imaging demonstrated the filter in good position without tilt, however, a detached filter limb was identified.Multiple attempts to retrieve the filter using a cone retrieval device were unsuccessful.There were no attempts made to retrieve the detached filter limb.The patient tolerated the procedure well and was hemodynamically stable at the conclusion of the procedure.No additional information surrounding this event was provided in the medical records received.

Manufacturer Narrative

H10: manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately three years and six months post deployment, the patient was scheduled for the filter retrieval.Using bard foreign body retrieval cone, it was able to capture the tip of the filter.However, it was unable to advance a 10-french sheath over the filter due to significant resistance.Because of the difficulty removing the filter along with patient experiencing abdominal pain, it was decided to abort the procedure.The images prior to retrieval attempt were revealed that the one of the arms was clearly broken.Therefore, the investigation is confirmed for filter limb detachment and retrieval difficulties.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.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 three years six months post vena cava filter deployment, the patient presented for retrieval of the filter.Imaging demonstrated the filter in good position without tilt, however, a detached filter limb was identified.Multiple attempts to retrieve the filter using a cone retrieval device were unsuccessful.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.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
• 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: 6166457
• MDR Text Key: 62235031
• Report Number: 2020394-2016-01159
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 30 YR
• Patient Sex: Female