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| Catalog Number RF310F |
| Device Problems
Difficult to Remove (1528); Malposition of Device (2616); Detachment of Device or Device Component (2907)
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| Patient Problems
Pulmonary Embolism (1498); Device Embedded In Tissue or Plaque (3165)
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| Event Date 10/03/2006 |
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Event Type
Injury
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Manufacturer Narrative
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Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided.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: a vena cava filter was indicated for an upcoming urologic surgery in the patient with a history of deep venous thrombosis.The right groin was prepped and draped sterilely.A percutaneous puncture of the right common femoral vein was performed easily.A 5 french sheath was inserted over a bentson wire.Hand injection tomography was then performed which demonstrated symmetrical location of the renal veins with inflow at the l1-2 vertebral interspace and no evidence of venous anomaly or thrombosis identified.The filter was successfully deployed infrarenal without difficulty with the tip just above the top of l2.The patient tolerated the procedure well and was transferred in stable condition.Approximately six weeks post filter deployment, chest ct demonstrated findings suggestive of acute on chronic pulmonary emboli.Approximately seven years post deployment, the patient sustained injuries following a motor vehicle accident which required orthopedic intervention.As a result, the patient consulted vascular surgery with concern regarding going off anticoagulation given his prior pulmonary embolus.The patient was asymptomatic, but inquired if a second filter would be beneficial.Approximately seven years one month post filter deployment, the patient presented for filter retrieval and replacement following a review of previous ct exams which revealed a tilted caval filter with a sizable hemi azygos vein that entered with the circumaortic left renal vein into the ivc at the level of the filter.It was felt this most likely represented the pathway of the patient¿s recurrent pulmonary embolism.The neck was prepped and draped in the usual manner and jugular access was obtained.Cavogram performed noted no significant thrombus.Extensive effort using a snare followed by biopsy forceps was required until ultimately the snare was successful in capturing and retrieving the filter.A follow-up cavogram showed no significant contrast extravasation noted.Another manufacturer¿s ivc filter was then placed more inferiorly in the ivc just above the iliac vein in excellent position.The sheath was removed and hemostasis was obtained.Approximately two years four months post filter retrieval, a chest ct report for retained foreign body fragments indicated that one or more limbs of the tilted filter detached at the time of retrieval.The report identified what appeared to be a linear metallic fragment (not present on prior exams) in the right lower hilum at its junction within the mediastinum and not within the vessel.This was closest to the left atrium.There was also a small metallic fragment against the medial left apex of the lung which was present on a prior chest ct.The patient was reported to be asymptomatic both at the time of the ct report and more than three years prior.Approximately two months later, the patient had a ct for hemoptysis and the filter fragments were found to be without surrounding inflammation and in stable position.The report noted that the radiologist discussed the findings with the patient regarding the filter fragments, reassuring that the fragments were not causing the hemoptysis, adding that they would likely never cause any trouble.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was not returned.Images were not provided.Medical records were provided.Six weeks post successful filter deployment, chest ct demonstrated findings suggestive of acute chronic pulmonary emboli.Seven years post deployment, the patient sustained injuries following a motor vehicle accident which required orthopedic intervention.One month post filter later, the patient presented for filter retrieval and replacement following a review of previous ct exams which revealed a tilted caval filter.Extensive effort using a snare followed by biopsy forceps was required until ultimately the snare was successful in capturing and retrieving the filter.It was noted that the filter was intact at the time that it was retrieved.Another manufacturer¿s ivc filter was then placed more inferiorly in the ivc just above the iliac vein in excellent position.Approximately two years and four months post filter retrieval, a chest ct report for retained foreign body fragments indicated that one or more limbs were detached.However, to which limb the filter belonged was not confirmed.Based on the provided medical records, the investigation is confirmed for a tilted filter and difficulties removing the filter.It can also be confirmed that there was pe after filter implantation.However, the investigation is inconclusive for the detached filter limbs as the limbs were not confirmed to belong to the bard filter.Per the provided medical records, a sizable hemi azygos vein entered with the circumaortic left renal vein into the ivc at the level of the filter.It was felt this most likely represented the pathway of the patient¿s recurrent pulmonary embolism.Additionally, it was noted the patient was involved in a motor vehicle accident after filter implantation.Per the instructions for use, open abdominal procedures may affect the integrity and stability of the filter.The impact associated with a motor vehicle accident could have the same as open procedure in regards to the integrity and stability of the filter.Therefore, the noted filter tilt may be attributed to the accident.The removal difficulties were most likely a result of the tilted filter.However, the definitive root cause cannot be determined.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; movement, migration or tilt of the filter are known complications of vena cava filters; perforation or other acute or chronic damage of the ivc wall; filter tilt; filter malposition; acute or recurrent pulmonary embolism.This has been reported despite filter usage.It is not known if thrombi passed through the filter, or originated from superior or collateral vessel.All of the above complications have been associated with serious adverse events such as medical intervention and/or death.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.
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Event Description
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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 six weeks post vena cava filter deployment, chest ct demonstrated pulmonary emboli.Approximately seven years one month post deployment, the patient presented for filter retrieval and replacement.Ct demonstrated filter tilt prior to retrieval.Multiple attempts using forceps and a snare were required to successfully retrieve the filter.Another manufacturer¿s ivc filter was then placed more inferiorly in the ivc just above the iliac vein in excellent position.The patient was hemodynamically stable at the conclusion.Approximately nine years five months post filter deployment, ct performed for retained foreign fragments demonstrated what appeared to be a linear metallic fragment in the right lower hilum at its junction within the mediastinum and not within the vessel.There was also a small metallic fragment against the medial left apex of the lung, seen on the patient's prior chest ct.It was additionally documented that one or more limbs of the tilted filter detached at the time of retrieval.The patient was reported to be asymptomatic at the time of report in addition to more three years prior.Approximately two months later, the patient had a ct for hemoptysis which identified the filter fragments to be stable and not the cause of hemoptysis.No additional medical records were received for this patient.
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Event Description
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New information received: medical records were received and reviewed.Approximately six weeks post vena cava filter deployment, chest ct demonstrated pulmonary emboli.Approximately seven years one month post deployment, the patient presented for filter retrieval and replacement.Ct demonstrated filter tilt prior to retrieval.Multiple attempts using forceps and a snare were required to successfully retrieve the filter.Another manufacturer¿s ivc filter was then placed more inferiorly in the ivc just above the iliac vein in excellent position.The patient was hemodynamically stable at the conclusion.Approximately nine years five months post filter deployment, ct performed for retained foreign fragments demonstrated what appeared to be a linear metallic fragment in the right lower hilum at its junction within the mediastinum and not within the vessel.There was also a small metallic fragment against the medial left apex of the lung, seen on the patient's prior chest ct.It was additionally documented that one or more limbs of the tilted filter detached at the time of retrieval.The patient was reported to be asymptomatic at the time of report in addition to more three years prior.Approximately two months later, the patient had a ct for hemoptysis which identified the filter fragments to be stable and not the cause of hemoptysis.No additional medical records were received for this patient.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 and in conjunction with or before orthopedic procedure.At some time post filter deployment, it was alleged that the filter detached, tilted and embedded in wall of the ivc.The device was removed percutaneously.It was further reported that the detached strut retained in right lower hilum of the junction with the mediastinum but not appearing in the vessel.The current status of the patient is unknown.
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Manufacturer Narrative
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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.Medical records were provided.Approximately two months post filter deployment, computed tomography revealed there was a pulmonary embolism with saddle embolus and involvement of multiple pulmonary arteries, including several segmental branches.Subsequently five days later, computed tomography revealed the filling defects were more peripheral and adherent to the wall in the right lower lobe pulmonary artery; this raised the possibility of chronic thromboembolism.Approximately seven years later, computed tomography revealed a tilted caval filter with a sizable hemi azygous vein that entered with the circumaortic left renal vein into the inferior vena cava at the level of the filter.Eventually, few days later filter retrieval was attempted.Multiple devices were used and a 5-french pigtail catheter was placed below the renal veins in the region of the inferior vena cava filter.A reverse curve catheter was placed below the level of the filter and an exchange length wire was looped through the filter ensnared.Attempts were made to retrieve the filter, but the mechanism was not successful.An attempt was also made to access the cone with a biopsy forceps again without success.Ultimately, an ensnare device was used to capture the tip of the filter and after extensive effort, the filter was removed intact.When the filter was removed, 1 or more of the legs fractured.Also, there appeared to be a small metallic fragment in the left apex medially, against the mediastinum.Therefore, the investigation is confirmed for filter limb detachment, filter tilt and retrieval difficulties.Additionally, it can be confirmed that the patient experienced pe post deployment.However, the relationship to the filter is unknown.Per medical records, multiple attempts were made to engage the apex of the filter using snare and forceps but were unsuccessful due to filter tilt.This could have contributed to the retrieval difficulties.However, the definitive root cause is unknown.Labeling review: instructions for use: only use the recovery cone® removal system to remove the g2 filter.Never re-deploy a removed filter.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.
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Event Description
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New information received: medical records were received and reviewed.Approximately six weeks post vena cava filter deployment, chest ct demonstrated pulmonary emboli.Approximately seven years one month post deployment, the patient presented for filter retrieval and replacement.Ct demonstrated filter tilt prior to retrieval.Multiple attempts using forceps and a snare were required to successfully retrieve the filter.Another manufacturer¿s ivc filter was then placed more inferiorly in the ivc just above the iliac vein in excellent position.The patient was hemodynamically stable at the conclusion.Approximately nine years five months post filter deployment, ct performed for retained foreign fragments demonstrated what appeared to be a linear metallic fragment in the right lower hilum at its junction within the mediastinum and not within the vessel.There was also a small metallic fragment against the medial left apex of the lung, seen on the patient's prior chest ct.It was additionally documented that one or more limbs of the tilted filter detached at the time of retrieval.The patient was reported to be asymptomatic at the time of report in addition to more three years prior.Approximately two months later, the patient had a ct for hemoptysis which identified the filter fragments to be stable and not the cause of hemoptysis.No additional medical records were received for this patient.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 and in conjunction with or before orthopedic procedure.At some time post filter deployment, it was alleged that the filter detached, tilted and embedded in wall of the ivc.The device was removed percutaneously.It was further reported that the detached strut retained in right lower hilum of the junction with the mediastinum but not appearing in the vessel.The current status of the patient is unknown.
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Manufacturer Narrative
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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.Medical records were provided.Approximately two months post filter deployment, computed tomography revealed there was a pulmonary embolism with saddle embolus and involvement of multiple pulmonary arteries, including several segmental branches.Subsequently five days later, computed tomography revealed the filling defects were more peripheral and adherent to the wall in the right lower lobe pulmonary artery; this raised the possibility of chronic thromboembolism.Approximately seven years later, computed tomography revealed a tilted caval filter with a sizable hemi azygous vein that entered with the circumaortic left renal vein into the inferior vena cava at the level of the filter.Eventually, few days later filter retrieval was attempted.Multiple devices were used and a 5-french pigtail catheter was placed below the renal veins in the region of the inferior vena cava filter.A reverse curve catheter was placed below the level of the filter and an exchange length wire was looped through the filter ensnared.Attempts were made to retrieve the filter, but the mechanism was not successful.An attempt was also made to access the cone with a biopsy forceps again without success.Ultimately, an ensnare device was used to capture the tip of the filter and after extensive effort, the filter was removed intact.When the filter was removed, 1 or more of the legs fractured.Also, there appeared to be a small metallic fragment in the left apex medially, against the mediastinum.Therefore, the investigation is confirmed for filter limb detachment, filter tilt and retrieval difficulties.Additionally, it can be confirmed that the patient experienced pe post deployment.However, the relationship to the filter is unknown.Per medical records, multiple attempts were made to engage the apex of the filter using snare and forceps but were unsuccessful due to filter tilt.This could have contributed to the retrieval difficulties.However, the definitive root cause is unknown.Labeling review: instructions for use: only use the recovery cone® removal system to remove the g2 filter.Never re-deploy a removed filter.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.
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Search Alerts/Recalls
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