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

Catalog Number RF310F

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2011

Event Type  malfunction  

Manufacturer Narrative

No medical images have been made available to the manufacturer.Medical records were provided and reviewed.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records review: the patient presented for vena cava filter placement due to history of deep vein thrombosis after knee surgery and desired prophylaxis for another scheduled knee surgery.The femoral vein was accessed and the filter was deployed.The patient tolerated the procedure well.Three and one half years later, the patient presented for consult for right knee replacement.It was decided to check for patency of the filter prior to surgery.A kub was obtained and the interventional radiologist noted the filter to be tilted but the struts appeared patent and deemed it still protective for the upcoming knee replacement.Additionally, the interventional radiologist noted the risk of removal of the ivc filter outweighed the benefits due to the age of the filter.No further information is noted regarding the patient¿s current status.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 through the litigation process that a vena cava filter was placed in a patient in conjunction with or before an orthopedic procedure.At some time post filter deployment, it was alleged that the filter tilted and embedded in the wall of the ivc.The device has not been removed and there was no reported removal attempt.There was no reported impact or consequence to the patient.

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.This is the only event reported to date for this lot number and failure mode.Medical records review: the patient presented for vena cava filter placement due to history of deep vein thrombosis after knee surgery and desired prophylaxis for another scheduled knee surgery.The femoral vein was accessed and the filter was deployed.The patient tolerated the procedure well.Three and one half years later, the patient presented for consult for right knee replacement.It was decided to check for patency of the filter prior to surgery.A kub was obtained and the interventional radiologist noted the filter to be tilted but the struts appeared patent and deemed it still protective for the upcoming knee replacement.Additionally, the interventional radiologist noted the risk of removal of the ivc filter outweighed the benefits due to the age of the filter.No further information is noted regarding the patient¿s current status.The device was not returned for evaluation and images were not provided for review.However, medical records were provided and reviewed.Approximately three and a half years after filter deployment, a kub was obtained and was noted that the filter was tilted.Therefore, based on the reported medical records, the investigation is confirmed for a tilted filter.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/possible complications include, but are not limited to, the following: movement, migration or tilt of the filter are known complications of vena cava filters.Filter tilt.Filter malposition.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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before an orthopedic procedure.At some time post filter deployment, it was alleged that the filter tilted and embedded in the wall of the ivc.The device has not been removed and there was no reported removal attempt.There was no reported impact or consequence to the patient.

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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately, eight years and eight months of post deployment, x-ray of kidney, ureter and bladder was performed which showed inferior vena cava filter was tilted.Around, three months later, inferior vena cava filter retrieval was performed which showed via the introducer sheath the long surgical forceps was used to engage the cephalad end of the filter.With the tip of the filter secured, the introducer sheath was advanced over the filter.The filter was then successfully withdrawn via the sheath.Three legs were noted to have remained adherent to the wall.Multiple attempts were made to remove these including the kumpe tulip snare a gooseneck snare and a snare and ultimately the forceps were used to remove these three legs.After this a small fragment of a leg which was noted to have been fractured off the original filter was now noted to be adherent to the wall in a horizontal position posteriorly.This was ultimately removed with the forceps as well.Post removal cone beam ct demonstrates no evidence of vascular injury to the inferior vena cava.There was excellent vena caval flow and no stenosis.The sheath was removed, and good hemostasis was achieved with manual compression.Therefore, the investigation is confirmed for filter limb detachment, and filter tilt.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: - movement, migration or tilt of the filter are known complications of vena cava filters.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.Possible complications include, but are not limited to, the following: - movement, migration or tilt of the filter are known complications of vena cava filters.- filter tilt.- filter malposition.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 conjunction with or before an orthopedic procedure.At some time post filter deployment, it was alleged that the filter tilted and embedded in the wall of the inferior vena cava.The device has not been removed and there was no reported removal attempt.There was no reported impact or consequence to the patient.

• 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: 7153483
• MDR Text Key: 96016970
• Report Number: 2020394-2017-01838
• 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,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2010
• Device Catalogue Number: RF310F
• Device Lot Number: GFRA1141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2007
• 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: CELEBREX, ULTRAM, CRESTOR, NEURONTIN, TOPROL XL; CELEBREX, ULTRAM, CRESTOR, NEURONTIN, TOPROL XL; CELEBREX, ULTRAM, CRESTOR, NEURONTIN, TOPROL XL; KETOCONAZOLE-HYDROCORTISONE, HYDROCHLOROTHIAZIDE; KETOCONAZOLE-HYDROCORTISONE, HYDROCHLOROTHIAZIDE; KETOCONAZOLE-HYDROCORTISONE, HYDROCHLOROTHIAZIDE
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 125 KG