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

Catalog Number RF310F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 11/15/2016

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: as medical records were not provided, a review could not be performed.Image/photo review: as medical images were not provided, a review could not be performed.Conclusion: the device was not returned.Images and medical records were not provided.The investigation is inconclusive for the reported event.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 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 approximately seven years five months post filter deployment, the filter was retrieved; however, one detached filter limb remains in the patient.The location of the detached limb is unknown.The patient status was not provided.

Event Description

It was reported that approximately seven years five months post filter deployment, the filter was retrieved; however, one detached filter limb remains in the patient.The location of the detached limb is unknown.The patient status was not provided.New information: 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.At some time post filter deployment, it was alleged that the filter tilted and embedded the wall of the ivc and detached.The device was removed percutaneously.The status of the patient is unknown.

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 record review:a vena cava filter was deployed for a preoperative diagnosis of recurrent dvts despite being on coumadin.It was noted the patient often noncompliant with coumadin.The deployed filter was placed via the common femoral vein.Inferior venacavogram performed during filter indicated placement at about the level of l2.The patient tolerated the procedure well.Approximately three and a half years post ivc deployment, the patient presented with leg swelling, an ultrasound confirmed a deep vein thrombosis of the left lower extremity.Due to patient experiencing leg pain one and a half years later, a repeat ultrasound revealed evidence of chronic deep vein thrombosis in the bilateral lower extremities.Approximately seven and a half years post ivc deployment, the patient presented with chronic embolism and thrombosis of both lower extremities.A ct of the abdomen and pelvis revealed good position of the ivc filter below the renal veins with the tip of the filter at the level of l2.Also indicated was perforation of the ivc with the ivc filter struts extended outside the wall.Fifteen days later, via the right internal jugular vein there was multiple unsuccessful attempts using a recovery cone retrieval system.The filter was successfully retrieved using a crocodile jaw forceps system with moderate difficulty.The visual inspection of the retrieved filter demonstrated the main body of the filter with some attached filter legs/struts.A ct scan and repeat cavogram demonstrated a small portion of retained legs/struts were protruding through the ivc wall.Retrieval was not attempted to remove the legs/struts due to the increase of injury, bleeding and pain.A repeat cavogram verified no thrombus, no ivc abnormality, or extravasation.Pathology report indicated retrieved ivc filter measuring measuring 4.5 cm in length by 3.0 cm in diameter.There are nine metallic struts that are smooth and shiny.One of the 9 struts appears to be broken.There is also an apparent strut missing.Approximately one month post filter retrieval, patient reports left-sided back and lower extremity shooting paints.Cta of the abdomen and pelvis demonstrated retained fractured filter legs within the l2/l3 anterolateral intervertebral disc space.No evidence of retroperitoneal hematoma.Stable left femoral vein calcification and extensive collateral veins within the lower anterior abdominal wall, draining left lower extremity to the contralateral side, suggesting chronic left femoral/iliac vein thrombosis.Patient to follow up with surgeon regarding alternative options to remove the retained struts.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Approximately seven and a half years post ivc deployment, a ct revealed perforation of the ivc with the filter struts extending outside the wall.Visual inspection post filter retrieval demonstrated the main body of the filter with some attached filter struts.Pathology report indicated nine metallic struts with one of the struts noted to be broken.Approximately one month post filter retrieval, a ct demonstrated retained fractured filter legs within the l2/l3 anterolateral intervertebral disc space.Therefore, the investigation can be confirmed for perforation of the ivc and limb detachment.However, the investigation is inconclusive for filter tilt.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings: 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 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: 01/2012, manufacturing date: 01/2009.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.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately seven years and five months post filter deployment, a computed tomography(ct) of abdomen and pelvis was performed which showed inferior vena cava filter was noted below the level of renal veins, with its tip at the level of l2 and the filter struts extended outside the borders of the inferior vena cava.Around two weeks later the patient was planned for filter retrieval procedure and through the right internal jugular vein approach, a retrieval sheath and dilator were advanced into the inferior vena cava distal to the filter.The sheath was then advanced into position to perform a cavogram and after verifying that the filter had not caught any clot, the decision was made to retrieve the filter.Three unsuccessful attempts were made to retrieve the filter using a recovery cone retrieval system as the filter was noted to be tilted and multiple legs had been noted to penetrate through the inferior vena cava wall.Subsequently the recovery cone retrieval system was removed over a amplatz wire the filter was retrieved using a crocodile jaw forceps system with moderate difficulty after the removal of the wire.The visual inspection of the filter demonstrated that main body and attached filter legs/struts were removed intact and upon further correlation with a ct scan taken two weeks back, it was noted that small portion of legs/struts were protruding through the inferior vena cava wall and had previously been fractured.Further retrieval of this was not attempted and a repeat cavogram was performed after filter removal verifying no demonstrate thrombus, no inferior vena cava abnormality or extravasation.Approximately one month after filter retrieval attempt, another computed tomography (ct) of abdomen and pelvis was performed and showed two linear hypodensities between inferior vena cava and the anterior or vertebral bodies at l2/3 level, which measures 1.2 cm and 1.4 cm in length, consistent with the fragments of the inferior vena cava filter.Therefore, the investigation is confirmed for the alleged filter tilt, perforation of the inferior vena cava, filter limb detachment and retrieval difficulties.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.H10: b2, d4(expiry date: 01/2012).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 seven years and five months post filter deployment, the filter was retrieved; however, one detached filter limb remains in the patient.The location of the detached limb is unknown.Further it was reported that the filter tilted and embedded the wall of the ivc.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: 6212629
• MDR Text Key: 63621638
• Report Number: 2020394-2016-01213
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• 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: GFSL1258
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2022
• 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
• Treatment: COUMADIN, ATENOLOL, CELECOXIB, LAMOTRIGINE.; COUMADIN, ATENOLOL, CELECOXIB, LAMOTRIGINE.; LOSARTAN, LOVASTATIN, METOPROLOL, PRISTIQ.; LOSARTAN, LOVASTATIN, METOPROLOL, PRISTIQ.; SIMVASTATIN, SUMATRIPTAN, SEPARARE, VITAMINS.; SIMVASTATIN, SUMATRIPTAN, SEPARARE, VITAMINS.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Race: White