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| Catalog Number RF310F |
| Device Problems
Detachment Of Device Component (1104); Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Protrusion/Extrusion (2979)
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| Patient Problems
Pulmonary Embolism (1498); Chest Pain (1776); Pain (1994); Great Vessel Perforation (2152); Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
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| Event Date 06/10/2009 |
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Event Type
Injury
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Manufacturer Narrative
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The device has not been returned, and no medical images have been made available to the manufacturer.A manufacturing review is currently being performed.The investigation of the reported event is currently underway.Based on the medical records received: patient had an ivc filter successfully deployed for a history of dvt and failed anticoagulation therapy.Approximately three days post filter deployment, a ct scan demonstrated a strut of the filter projecting posterior to the aorta, and what appeared to be two other struts outside of the lumen of the ivc.Approximately four months post filter deployment, attempted filter retrieval was unsuccessful.Imaging demonstrated filter tilt with the cone abutting the right lateral wall.Approximately three years post filter deployment, a ct scan demonstrated an abnormal filter axis, a detached strut in the left lower lobe pulmonary arterial branch and a detached strut in the right ventricle.A cardiac doppler study demonstrated no evidence of a foreign body in the right heart chambers.The patient was seen by a hcp for complaints of pain and shortness of breath.The hcp reviewed previous imaging that demonstrated a detached filter leg within the left lower lobe pulmonary artery, a detached filter leg within the right ventricle and a detached filter leg adjacent to the filter.Review of a previous echo and cardiac doppler demonstrated no metal filament within the right ventricle.The hcp stated that the removal of the filter would be best for pain relief and avoidance of future filter migration and fragmentation.The hcp stated that the fragment within the left lower lobe pulmonary artery should be stable, and risk of removing it would outweigh potential benefits.An attempt was made to retrieve the foreign body in the ivc.Imaging demonstrated two detached filter limbs within the ivc at the level of the filter.The detached limbs were not retrieved.The patient had a consultation for filter retrieval.Review of previous imaging demonstrated the filter tip embedded along the right caval wall, two filter legs protruding in the retroaortic space, one component extending anteriorly towards the bowel and one detached component extending along the posterior caval wall.The hcp stated: filter retrieval is desired in order to help alleviate pain from component penetration; any old fragments that have embolized would be left alone; and any newly embolized pieces of the filter would be removed if identified during the procedure.Scout imaging demonstrated: rightward deviation of the filter hook; detachment of three arms and one leg of the filter; one detached arm in the left lower lung field; one detached arm and leg in the region of the ivc at the level of the filter; one of the six arms of the filter are not identified.Imaging further demonstrated penetration of at least two legs and two arms medially outside of the ivc lumen.The following day the filter was retrieved successfully by blunt tissue dissection with rigid forceps.Attempts were made to remove the two detached filter limbs that had perforated the ivc wall unsuccessfully.Imaging demonstrated stability of two previously detached filter limbs in the retroperitoneum, and one previously detached filter limb in a subsegmental branch of the left pulmonary artery.Patient was reported to be hemodynamically stable.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 three days post vena cava filter deployment, ct scan demonstrated a filter limb perforating the posterior ivc wall.Approximately four months post vena cava filter deployment, an attempt to retrieve the filter was unsuccessful.Guided fluoroscopy demonstrated the filter was tilted with the apex against the ivc wall.The retrieval device was unable to capture and retrieve the vena cava filter.Approximately three years post vena cava filter deployment, an unsuccessful attempt was made to retrieve the vena cava filter.Guided fluoroscopy demonstrated two detached filter limbs protruding into the retroperitoneal space.As well as one detached limb extending along the posterior ivc wall.A snare device was unable to capture and retrieve the detached filter limbs.Approximately two months following the second unsuccessful filter retrieval attempt, the filter was retrieved successfully by blunt tissue dissection with rigid forceps to capture and retrieve the vena cava filter.Additional attempts were made with the forceps to remove the two detached filter limbs that had perforated the ivc wall near the retroperitoneum unsuccessfully.Guided fluoroscopy indicated the detached filter limbs were in stable position.Patient was reported to be hemodynamically stable at the conclusion the procedure.No other reported attempts have been made to remove the detached limbs.
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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.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: as medical images were not provided, a review could not be performed.Conclusion: the medical records allege that the filter was tilted with the apex against the ivc wall.Several struts were allegedly perforating through the ivc wall.An unsuccessful retrieval attempt was allegedly performed approximately 7 weeks after implantation.The patient allegedly delivered a full term baby via c-section.Allegedly a ct scan demonstrated two broken struts, one in the left lower pulmonary lobe and the other in the right ventricle.The filter was successfully removed approximately 51 months after implantation.Three arms and one leg were reportedly detached.Two limbs were reportedly outside the ivc lumen in stable positions.One limb was reportedly in the lower left lung field and the fourth limb was not visualized.Based on the medical records, filter tilt, perforation of the ivc, an unsuccessful retrieval attempt, and limb detachment can be confirmed.The filter was likely difficult to remove if the filter was tilted and the apex was embedded in the ivc wall.It is unknown why the filter became tilted and perforated the ivc wall.It is possible the patient's pregnancy affected the stability of the filter which caused the limbs to detach.It is also possible that some of the limbs detached during the initial attempts to remove the filter.However, 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.Movement, migration or tilt of the filter are known complications of vena cava filters.- potential complications: procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.Possible complications include, but are not limited to, the following: perforation or other acute or chronic damage of the ivc wall.Filter tilt.Filter malposition.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 three days post vena cava filter deployment, ct scan demonstrated a filter limb perforating the posterior ivc wall.Approximately four months post vena cava filter deployment, an attempt to retrieve the filter was unsuccessful.Guided fluoroscopy demonstrated the filter was tilted with the apex against the ivc wall.The retrieval device was unable to capture and retrieve the vena cava filter.Approximately three years post vena cava filter deployment, an unsuccessful attempt was made to retrieve the vena cava filter.Guided fluoroscopy demonstrated two detached filter limbs protruding into the retroperitoneal space.As well as one detached limb extending along the posterior ivc wall.A snare device was unable to capture and retrieve the detached filter limbs.Approximately two months following the second unsuccessful filter retrieval attempt, the filter was retrieved successfully by blunt tissue dissection with rigid forceps to capture and retrieve the vena cava filter.Additional attempts were made with the forceps to remove the two detached filter limbs that had perforated the ivc wall near the retroperitoneum unsuccessfully.Guided fluoroscopy indicated two detached filter limbs in the retroperitoneum, and one detached limb in the left pulmonary artery in stable position.Patient was reported to be hemodynamically stable at the conclusion the procedure.No other reported attempts have been made to remove the detached limbs.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.Sometime post filter deployment, it was alleged that the filter tilted and embedded in the wall of the inferior vena cava and filter limbs perforated and detached.It was further alleged that the patient experienced a pulmonary embolism.The device was removed percutaneously after an attempted but unsuccessful percutaneous removal procedure.However, two detached limbs in the retroperitoneum, one detached limb in the lung, and one detached limb in an unknown location remain in the patient.The current status of the patient is unknown.
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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.Medical records review: the patient had a vena cava filter successfully deployed for a history of deep vein thrombosis and failed anticoagulation therapy.Approximately three days post filter deployment, a computed tomography (ct) scan demonstrated a multiple struts of the filter outside of the lumen of the inferior vena cava with one strut projecting posterior to the aorta.Approximately four months post filter deployment, filter retrieval was unsuccessful.Imaging demonstrated filter tilt with the cone abutting the right lateral wall.Approximately three years post filter deployment, a ct scan demonstrated an abnormal filter axis, a detached strut in the pulmonary artery (pa) and a detached strut in the right ventricle (rv).A cardiac doppler study demonstrated no evidence of a foreign body in the right heart chambers.The patient was seen by a health care professional (hcp) for complaints of pain and shortness of breath.The hcp reviewed previous imaging that demonstrated a detached filter leg within the left lower lobe pulmonary artery, a detached filter leg within the rv and a detached filter leg adjacent to the filter.Review of a previous echocardiogram and cardiac doppler demonstrated no metal filament within the rv.The hcp stated that the removal of the filter would be best for pain relief and avoidance of future filter migration and fragmentation.The hcp stated that the fragment within the pa should be stable, and risk of removing it would outweigh potential benefits.Approximately three years and one month post filter deployment, an attempt to retrieve the two detached filter limbs within the ivc were unsuccessful.Approximately three years and two moths post filter deployment, the filter was retrieved successfully with rigid forceps.Attempts to remove the two detached filter limbs in the ivc wall were unsuccessful.Patient was reported to be hemodynamically stable.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Based on the medical records, the investigation can be confirmed for filter tilt, perforation of the ivc, retrieval difficulties, and limb detachment.However, the investigation is inconclusive for pe post deployment.The filter was likely difficult to remove if the filter was tilted and the apex was embedded in the ivc wall.It is possible the patient's pregnancy affected the stability of the filter.It is also possible that some of the limbs detached during the initial attempts to remove the filter.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: 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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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.On the next day of post deployment, an x-ray of kidney, ureter and bladder was performed for pain in the right buttock area and right iliac crest.The study showed that the inferior vena cava filter was essentially in the same position below the level of l2 but has tilted slightly toward the right.Also, it was suspected that one of the legs of the filter has extended into a large left-sided lumbar vein at the l3 level seen on yesterday's inferior vena cavogram.However, in this position, the filter will still trap blood clots which might originate in the lower extremities.The final impression was provided as a slight tilted of the inferior vena caval filter toward the right since yesterday's placement.Around, four months and two weeks later, the bard g2 inferior vena cava filter was attempted for removal.The right internal jugular vein was accessed, and a 10-french sheath was placed.Then a 5-french diagnostic catheter was advanced through the superior vena cava into the inferior vena cava and an inferior vena cavagram was performed which showed the filter to be tilted, with the cone abutted the right lateral wall.Prolonged attempts were made at retrieval of the inferior vena cava filter including the manufacturer's retrieval device and vascular snares.Despite prolonged attempts using a variety of catheters and snares, the cone of the filter could not be grasped, mainly due to inability to advance a catheter or wire between the filter cone and inferior vena cava wall.Finally, unsuccessful attempted inferior vena cava filter retrieval due to filter angulation and adherence of the filter cone to the inferior vena cava wall.Around, one month and one week later, an obstetrical ultrasound was performed for placenta previa.The study showed that the filter to lie posteriorly eccentrically within the inferior vena cava immediately below the renal veins.Also, no evidence of caval thrombus, and no suggestion of filter or inferior vena cava compromised by the enlarging placenta, which remained well away from the segment containing the filter.Around, three months later, a computed tomography of abdomen was performed for chronic deep vein thrombosis.The study showed that there was an inferior vena cava filter present.Around, three months later, an x-ray of kidney, ureter and bladder was performed for hydronephrosis.The study showed there was an inferior vena cava filter present.A computed tomography of abdomen and pelvis was also performed in the same day for left leg deep vein thrombosis associated with may-turner syndrome.The study showed the filter within the inferior vena cava was unchanged.Around, seven months later, a computed tomography of abdomen and pelvis was performed for right lower quadrant pain.The study showed that there was still an inferior vena caval filter located about 2 cm below the renal veins and at least two of the legs of the filter extended into a left vena cava branch vein which extended behind the aorta.An impression was provided as a stable, tilted, removable inferior vena cava filter located about 2 cm below the renal veins.Around, six months later, an x-ray of abdomen was performed for abdominal pain.The study showed an inferior vena cava filter in place.Around, three months later, a computed tomography angiography of abdomen and pelvis was performed for evaluating pregnancy with inferior vena cava filter and stent placements for clot.The study showed that there were prongs from previous inferior vena cava filter visualized and were outside the wall of the inferior vena cava predominantly just inferior to the level of the renal veins and just superior to the level and at the level of both infrarenal stents as seen previously with the remaining filter predominantly no longer present.Also, small metallic objects visualized within the right ventricle thought to most likely represent a prong from the previously seen inferior vena cava filter and majority of the filter was no longer present.Around, six months later, a computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that an inferior vena cava filter was present and not only was the axis of the fitter abnormal, at least two of the struts have broken, one of which can be seen in a nonoccluded left lower lobe pulmonary arterial branch and the other in the right ventricle.Embolization of a portion of the inferior vena cava filter has occurred in the past to the left lower lobe pulmonary arterial branch but was not producing pulmonary arterial occlusion.Around, one month later, the patient visited for follow up regarding inferior vena cava filter.An interventional radiologic report mentioned that the patient reported chronic mid back pain, diffused intermittent abdominal pain and occasional right shoulder pain.There was also unpredictable episodic diffused chest pain.A review of imaging studies mentioned that in previous years demonstrated a progression of leg fractures of the bard g2 nitinol filter in the inferior vena cava and its tilted configuration had remained unchanged.However, a most recent computed tomographic scan demonstrated a fractured filter leg within a left lower lobe pulmonary artery, one within the right ventricle near the tricuspid valve and one adjacent to the filter within the inferior vena cava.A related problem has been retrograde migration and tilting of the inferior vena cava filter, and over the last two years, had undergone fragmentation and migration to the left lung and light heart.It was believed that back, and possibly, abdominal symptoms could be attributable to the filter, especially the legs extending into the anterior lumbar tissues.The physician explained that since the inferior vena cava filter became malpositioned, there could have potentially been impingement on nerves in the anterior aspect of the spinal column and caused a potential nerve irritation.The back pain was centered around this specific region and these nerves could be irritated and contributed to pain.Around, one month later, the bard g2 inferior vena cava filter was again attempted for retrieval along with the fractured struts.The right internal jugular vein was accessed, and a 4-french vascular sheath was placed which was then advanced through the right atrium into the inferior vena cava.Then a 4-french pigtail catheter was advanced through the inferior vena cava into a stent extended into the right common iliac vein, and ultimately, to the right common femoral vein.A vena cavagram was performed which demonstrated the cone of the filter lied adjacent to the right lateral wall and also showed fracture of a filter leg and arm within the inferior vena cava at the level of the filter.Next attention was made at retrieval of fractured filter legs within the inferior vena cava adjacent to the filter.However, attempts at 7 mm snare retrieval were unsuccessful.Finally, it was concluded with fractured filter arm and leg within the inferior vena cava adjacent to the filter, with unsuccessful retrieval attempt.Around, one month and three weeks later, the bard g2 inferior vena cava filter was removed.The patient underwent major surgery in order to remove the filter, the filter was removed, however pieces remained within the patient¿s body.Around, four years and six months later, during consultation it was mentioned that there has been partial removal of inferior vena cava filter with fragments apparently still in place in the inferior vena cava as well as in the heart.Around, one year and two months later, during follow up visit it was mentioned that the patient had inferior vena cava filter which had fragmented and partly of this fragment was in the abdomen was removed and the other fragments were in the lung.Around, two years and three months later, a computed tomography of abdomen and pelvis was performed for pain in lower back and pelvis.The study showed that an unchanged linear metal foreign body at right ventricle heart so consider if this was the known broken off strut of inferior vena cava filter.The study also showed that there were linear metal densities at anterior and posterior low inferior vena cava margins just above stents consistent with broken off struts of inferior vena cava filter given history.Therefore, the investigation is confirmed the perforation of the inferior vena cava (ivc), filter tilt, filter limb detachment, and retrieval difficulties.However, the investigation is inconclusive for pulmonary embolism post deployment (pe).Per medical records, despite prolonged attempts using a variety of catheters and snares, the cone of the filter could not be grasped, mainly due to inability to advance a catheter or wire between the filter cone and inferior vena cava wall.However, 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, b6, d10, g3, h6 (patient, method, conclusion).H11: b3, g1.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 after being diagnosed with deep vein thrombosis/pulmonary embolism.Approximately three days post vena cava filter deployment, a computed tomography scan demonstrated a filter limb perforating the posterior ivc wall.Approximately four months post vena cava filter deployment, an attempt to retrieve the filter was unsuccessful.Guided fluoroscopy demonstrated the filter was tilted with the apex against the ivc wall.The retrieval device was unable to capture and retrieve the vena cava filter.Approximately three years post vena cava filter deployment, an unsuccessful attempt was made to retrieve the vena cava filter.Guided fluoroscopy demonstrated two detached filter limbs protruding into the retroperitoneal space.As well as one detached limb extending along the posterior ivc wall.A snare device was unable to capture and retrieve the detached filter limbs.Approximately two months following the second unsuccessful filter retrieval attempt, the filter was retrieved successfully by blunt tissue dissection with rigid forceps to capture and retrieve the vena cava filter.Additional attempts were made with the forceps to remove the two detached filter limbs that had perforated the ivc wall near the retroperitoneum unsuccessfully.Guided fluoroscopy indicated two detached filter limbs in the retroperitoneum, and one detached limb in the left pulmonary artery in stable position.The patient was diagnosed with pulmonary embolism post filter implant.The current status of the patient is unknown.
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Search Alerts/Recalls
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