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| Catalog Number RF048F |
| Device Problems
Migration or Expulsion of Device (1395); Unstable (1667); Device Or Device Fragments Location Unknown (2590); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Migration (4003)
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| Patient Problems
Pain (1994); Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
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| Event Date 10/05/2006 |
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Event Type
Injury
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Manufacturer Narrative
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No device or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.Medical records were received and reviewed and the investigation of the reported event is currently underway.Medical record review: based on the medical record review the patient had a vena cava filter deployed successfully for protection of dvt and pe, two weeks prior to an open gastric bypass surgery.Approximately five months post open gastric bypass surgery the patient had a surgical revision performed to repair the bleeding gastric ulcer.One month later an additional surgical revision was performed for resection of the gastric ulcer.Approximately two years post vena cava filter deployment x-rays identified a metallic foreign body within the right lung and the right ventricle.The radiologist report questioned at that time if the foreign body was a residual pacer maker wire or a detached filter limb.A ct scan of the abdomen was performed the following day for verification of the vena cava filter.The ct scan did not demonstrate any detached limbs, the filter remained intact.Three years post vena cava filter deployment medical records indicated two surgical staples had migrated to the heart and lung.Seven years post vena cava filter deployment abdominal x-rays identified filter tilt.Two weeks later the filter was successfully retrieved; however, two detached filter limbs were identified to be missing from the filter.Guided fluoroscopy was unable to identify the location of the two detached filter limbs.The procedure was concluded.Patient was reported to be hemodynamically stable and in good condition.No additional attempts were made to locate the two detached filter limbs.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 approximately two years post vena cava filter deployment for protection from pulmonary embolus, a gastric bariatric bypass was performed one month post filter deployment.Two years post filter deployment a ct scan demonstrated a metallic curvilinear foreign body in the right ventricle of the heart.The identity of the foreign body was unknown at that time.A follow-up ct performed following day did not demonstrate any filter limb detachment.Three years post filter deployment, hospital records indicated that two surgical staples had migrated; one to the heart and one to the pulmonary artery.Seven years post filter deployment a ct scan demonstrated the filter to be tilted and located at the level of l-3 of the lumbar spine.There was no report of filter limb detachment at that time.Eight years post filter deployment the filter was successfully retrieved without incident; however, two detached filter limbs were identified at the time of the retrieval.Guided fluoroscopy was unable to identify the location of the two detached filter limbs.The patient was reported to be hemodynamically stable and in good condition.
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Manufacturer Narrative
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The lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.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.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was not returned.Medical records were provided.The medical records allege the patient had a filter placed prior to open gastric bypass surgery.Several revisions of the gastric bypass surgery were allegedly performed.A chest x-ray and chest ct identified a metallic foreign body in the right lung.It was unknown if the foreign body was a residual pacer wire or strut from the ivc filter.A follow up pelvic ct allegedly demonstrated no evidence of a fractured filter or missing strut.Paperwork from a hospitalization in 2007 alleged two staples migrated and one was located within the heart and one in the lungs.An abdominal x-ray in 2012 identified the filter to be allegedly tilted within the ivc.Allegedly, the filter was successfully retrieved and two struts were found to be missing.Based on the medical records, the investigation is confirmed for filter tilt and two detached limbs.Per the medical records, the patient had open gastric bypass surgery and several follow up revisions while the filter was implanted.Therefore, it is possible that procedural issues contributed to the reported event.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings: filter fracture is a known complication of vena cava filters.There have been reports for embolization of vena cava filter fragments resulting in retrieval of fragment using endovascular and/or surgical techniques.Most cases of the filter fracture, however, have been reported without any adverse clinical sequelae.Movement or migration of the filter is a known complication.This may be caused by placement in the ivc's with diameters exceeding the appropriate labeled dimensions specified in the ifu.
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Manufacturer Narrative
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No medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records was performed.The device has not been returned to the manufacturer for evaluation.Medical records were previously received and reviewed and the investigation of additional information regarding the reported event is currently underway.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 had a vena cava filter deployed successfully for protection of dvt and pe, two weeks prior to an open gastric bypass surgery.Approximately five months post open gastric bypass surgery the patient had a surgical revision performed to repair the bleeding gastric ulcer.One month later an additional surgical revision was performed for resection of the gastric ulcer.Approximately two years post vena cava filter deployment x-rays identified a metallic foreign body within the right lung and the right ventricle.The radiologist report questioned at that time if the foreign body was a residual pacer maker wire or a detached filter limb.A ct scan of the abdomen was performed the following day for verification of the vena cava filter.The ct scan did not demonstrate any detached limbs, the filter remained intact.Three years post vena cava filter deployment medical records indicated two surgical staples had migrated to the heart and lung.Seven years post vena cava filter deployment abdominal x-rays identified filter tilt.Two weeks later the filter was successfully retrieved; however, two detached filter limbs were identified to be missing from the filter.Guided fluoroscopy was unable to identify the location of the two detached filter limbs.The procedure was concluded.Patient was reported to be hemodynamically stable and in good condition.No additional attempts were made to locate the two detached filter limbs.Image/photo review: as medical images were not provided, a review could not be performed.Conclusion: neither the device or images were returned.Medical records were provided.The medical records allege the patient had a filter placed prior to open gastric bypass surgery.Several revisions of the gastric bypass surgery were allegedly performed.A chest x-ray and chest ct identified a metallic foreign body in the right lung.It was unknown if the foreign body was a residual pacer wire or strut from the ivc filter.A follow up pelvic ct allegedly demonstrated no evidence of a fractured filter or missing strut.Paperwork from a hospitalization in 2007 alleged two staples migrated and one was located within the heart and one in the lungs.An abdominal x-ray in 2012 identified the filter to be allegedly tilted within the ivc.Allegedly, the filter was successfully retrieved and two struts were found to be missing.Based on the medical records, the investigation is confirmed for filter tilt and two detached limbs.Per the medical records, the patient had open gastric bypass surgery and several follow up revisions while the filter was implanted.Therefore, it is possible that procedural issues contributed to the reported event.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: possible complications include but are not limited to the following: filter fracture is a known complication of vena cava filters.There have been reports for embolization of vena cava filter fragments resulting in retrieval of fragment using endovascular and/or surgical techniques.Most cases of the filter fracture, however, have been reported without any adverse clinical sequelae.Movement or migration of the filter is a known complication.This may be caused by placement in the ivc's with diameters exceeding the appropriate labeled dimensions specified in the ifu.(b)(4).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 approximately two years post vena cava filter deployment for protection from pulmonary embolus, a gastric bariatric bypass was performed one month post filter deployment.Two years post filter deployment a ct scan demonstrated a metallic curvilinear foreign body in the right ventricle of the heart.The identity of the foreign body was unknown at that time.A follow-up ct performed following day did not demonstrate any filter limb detachment.Three years post filter deployment, hospital records indicated that two surgical staples had migrated; one to the heart and one to the pulmonary artery.Seven years post filter deployment a ct scan demonstrated the filter to be tilted and located at the level of l-3 of the lumbar spine.There was no report of filter limb detachment at that time.Eight years post filter deployment the filter was successfully retrieved without incident; however, two detached filter limbs were identified at the time of the retrieval.Guided fluoroscopy was unable to identify the location of the two detached filter limbs.The patient was reported to be hemodynamically stable and in good condition.New information received: it was reported that approximately two years five months post vena cava filter deployment, the patient allegedly experienced significant physical injuries as a result of the following events: the filter embedded, migrated, tilted, detached, perforated and/or otherwise became irretrievable.No additional information was provided.
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Manufacturer Narrative
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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 had a vena cava filter deployed successfully for protection of dvt and pe, two weeks prior to an open gastric bypass surgery.Approximately five months post open gastric bypass surgery the patient had a surgical revision performed to repair the bleeding gastric ulcer.One month later an additional surgical revision was performed for resection of the gastric ulcer.Approximately two years post vena cava filter deployment x-rays identified a metallic foreign body within the right lung and the right ventricle.The radiologist report questioned at that time if the foreign body was a residual pacer maker wire or a detached filter limb.A ct scan of the abdomen was performed the following day for verification of the vena cava filter.The ct scan did not demonstrate any detached limbs, the filter remained intact.Three years post vena cava filter deployment medical records indicated two surgical staples had migrated to the heart and lung.Seven years post vena cava filter deployment abdominal x-rays identified filter tilt.Two weeks later the filter was successfully retrieved; however, two detached filter limbs were identified to be missing from the filter.Guided fluoroscopy was unable to identify the location of the two detached filter limbs.The procedure was concluded.Patient was reported to be hemodynamically stable and in good condition.No additional attempts were made to locate the two detached filter limbs.Image/photo review: as medical images were not provided, a review could not be performed.Conclusion: neither the device or images were returned.Medical records were provided.The medical records allege the patient had a filter placed prior to open gastric bypass surgery.Several revisions of the gastric bypass surgery were allegedly performed.A chest x-ray and chest ct identified a metallic foreign body in the right lung.It was unknown if the foreign body was a residual pacer wire or strut from the ivc filter.A follow up pelvic ct allegedly demonstrated no evidence of a fractured filter or missing strut.Paperwork from a hospitalization in 2007 alleged two staples migrated and one was located within the heart and one in the lungs.An abdominal x-ray in 2012 identified the filter to be allegedly tilted within the ivc.Allegedly, the filter was successfully retrieved and two struts were found to be missing.There is no mention of migration or perforation within the medical records.Based on the medical records, the investigation is confirmed for filter tilt and two detached limbs.The investigation is unconfirmed for the filter being irretrievable.The investigation is inconclusive for migration and perforation.Per the medical records, the patient had open gastric bypass surgery and several follow up revisions while the filter was implanted.Therefore, it is possible that procedural issues contributed to the reported event.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: possible complications include but are not limited to the following: filter fracture is a known complication of vena cava filters.There have been reports for embolization of vena cava filter fragments resulting in retrieval of fragment using endovascular and/or surgical techniques.Most cases of the filter fracture, however, have been reported without any adverse clinical sequelae.Movement or migration of the filter is a known complication.This may be caused by placement in the ivc's with diameters exceeding the appropriate labeled dimensions specified in the ifu.Perforation of other acute or chronic damage of the ivc wall.(b)(4).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 approximately two years post vena cava filter deployment for protection from pulmonary embolus, a gastric bariatric bypass was performed one month post filter deployment.Two years post filter deployment a ct scan demonstrated a metallic curvilinear foreign body in the right ventricle of the heart.The identity of the foreign body was unknown at that time.A follow-up ct performed following day did not demonstrate any filter limb detachment.Three years post filter deployment, hospital records indicated that two surgical staples had migrated; one to the heart and one to the pulmonary artery.Seven years post filter deployment a ct scan demonstrated the filter to be tilted and located at the level of l-3 of the lumbar spine.There was no report of filter limb detachment at that time.Eight years post filter deployment the filter was successfully retrieved without incident; however, two detached filter limbs were identified at the time of the retrieval.Guided fluoroscopy was unable to identify the location of the two detached filter limbs.The patient was reported to be hemodynamically stable and in good condition.New information received: it was reported that approximately two years five months post vena cava filter deployment, the patient allegedly experienced significant physical injuries as a result of the following events: the filter embedded, migrated, tilted, detached, perforated and/or otherwise became irretrievable.No additional information was provided.
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Manufacturer Narrative
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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.Approximately, five months of post deployment, a computed tomography of abdomen and pelvis was performed for epigastric pain.The study showed that inferior vena cava filter was noted.Around, one year and ten days later, a computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that inferior vena cava filter was noted.Around, three months and fourteen days later, an x-ray lumbar spine was performed for back pain.The study showed that inferior vena cava filter was noted.Around, two months later, an x-ray abdomen was performed for abdominal pain which showed inferior vena cava filter was noted at the right lateral margin of the l2 vertebra.After, three days, a computed tomography of abdomen and pelvis was performed which showed inferior vena cava filter was noted.On the next day, an x-ray abdomen was performed which showed inferior vena cava filter projects over the upper abdomen.After, four days, an x-ray abdomen was performed which showed inferior vena cava filter was noted in unchanged appearance.Around, six months and fourteen days later, an x-ray chest was performed for cough which showed a fine metallic structure projects over the lungs on two views.Not to exclude a foreign object within the right lung.After, twenty-nine days, a computed tomography of chest was performed for foreign body in the lung.The study showed that curvilinear area of metallic density which lies in the right ventricle with a portion overlying the interventricular septum.Question whether this represents a portion of residual pacer wire or strut of the inferior vena cava filter.On the next day, a computed tomography of abdomen was performed which showed inferior vena cava filter was noted without evidence of strut malfunction or fracture.After, twenty-nine days, an x-ray chest was performed which showed radiopaque density measuring approximately 2 cm projecting over the right hemithorax was unchanged.This may represent a foreign body and correlation with the patient¿s clinical history.An x-ray abdomen was performed for abdominal pain.The study showed that inferior vena cava filter to the right of the spine at the level of l2-l3.Around, three months and twenty-six days later, an x-ray chest was performed for chest pain.The study showed that tiny thin metallic density again projects the right lower lung.Around, one year and nine months later, a computed tomography of abdomen and pelvis was performed which showed inferior vena cava filter was noted at the level of l2-l3 vertebrae.Around, seven months later, an x-ray chest was performed which showed a linear metallic density projected over the right anterior 4th rib that overlies the middle lobe on lateral view.After, thirteen days, an x-ray chest was performed for chest pain.The study showed that very thin metallic density was again noted projecting over the right mid lung.Around, one year eight months later, a computed tomography of abdomen and pelvis was performed for periumbilical pain.The study showed that inferior vena cava filter was noted in good position.After, eight days, an echocardiogram was performed for chest pain.The study showed that left ventricle was normal in size with mild concentric hypertrophy.There was an echo density in the apical views in the lower interventricular septum.This may be consistent with a foreign body.Around, one year and one month later, a diagnostic study of abdomen was performed for fractured inferior vena cava filter.The study showed that filter was projected over the l2 and l3 vertebral bodies.The inferior most tines of the filter are seen along the inferior endplate of l3 vertebral body and filter was tilted 25 degrees laterally to the right from midline with respect to the lumbar spine.The lateral view demonstrated filter was tilted anteriorly with respect to midline about 15 degrees anterior to the l3 vertebral body.One of the tines of the filter was projected over the anterior portion of the cardiac silhouette on the lateral view.This was seen on the right ventricle of the heart.On the same day, a computed tomography of abdomen was performed for fractured inferior vena cava filter.The study showed that inferior vena cava filter was noted with the proximal portion of the filter tip lies at the inferior t2 end plate level.After, twenty-three days, patient presented for filter retrieval procedure due to strut fractures.Through the right internal jugular vein approach, benson wire was passed right next to the most superior portion of the tip of the filter.Then placed a recovery sheath introducer above the top of the filter.Then passed the bard recovery basket down into the filter and was able to engage the filter and confirmed.Able to withdraw with a little resistance, but not too much detach the filter and withdraw it into the sheath.The filter was withdrawn into the recovery cartridge and out the sheath.It appeared that there was some minimal tissue attachment to the top of the filter and one or two of the anchoring struts appeared that two of the shoulder tines were not present on the extracted filter a completion cavogram was performed which showed brisk flow and no extravasation and no gross abnormality of the cava.Therefore, the investigation is confirmed for filter tilt, filter limb detachment and filter migration.However, the investigation is inconclusive for perforation of the inferior vena cava (ivc).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.The current instructions for use states: warnings: - filter fracture is a known complication of vena cava filters.There have been reports for embolization of vena cava filter fragments resulting in retrieval of fragment using endovascular and/or surgical techniques.Most cases of the filter fracture, however, have been reported without any adverse clinical sequelae.- movement or migration of the filter is a known complication.This may be caused by placement in the ivc's with diameters exceeding the appropriate labeled dimensions specified in the ifu.Potential complications: possible complications include but are not limited to the following: -movement or migration of the filter is a known complication.This may be caused by placement in the ivc's with diameters exceeding the appropriate labeled dimensions specified in the ifu.-filter fracture is a known complication of vena cava filters - perforation of other acute or chronic damage of the ivc wall.H10: b5,b6,g3 h11: b2,d10,g1,h6(patient, device, method, 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.
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Event Description
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It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure and due to history of pulmonary embolism.Two years post filter deployment a computed tomography scan demonstrated a metallic curvilinear foreign body in the right ventricle of the heart.The identity of the foreign body was unknown at that time.A follow-up computed tomography performed following day did not demonstrate any filter limb detachment.Three years post filter deployment, hospital records indicated that two surgical staples had migrated; one to the heart and one to the pulmonary artery.Seven years post filter deployment a computed tomography scan demonstrated the filter to be tilted and located at the level of l-3 of the lumbar spine.There was no report of filter limb detachment at that time.Eight years post filter deployment the filter was successfully retrieved without incident; however, two detached filter limbs were identified at the time of the retrieval.Guided fluoroscopy was unable to identify the location of the two detached filter limbs.Further, the filter embedded and perforated.One detached strut retained in the right ventricle of heart and other in lung.The device was removed percutaneously.The current status of the patient is unknown.
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Search Alerts/Recalls
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