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

Catalog Number RF400J

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Material Deformation (2976); Positioning Problem (3009)

Patient Problem Abdominal Pain (1685)

Event Date 04/29/2010

Event Type  Injury  

Manufacturer Narrative

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.Bard g2 x filter was deployed in the suprarenal inferior vena cava for a patient with right lower extremity deep vein thrombosis.A venogram was performed prior deployment which showed there was a large caval thrombus noted extended up to the level of the renal vein inflow.So, therefore, the inferior vena cava filter was deployed in the suprarenal inferior vena cava.Post deployment study showed successful placement of suprarenal inferior vena cava filter.However, once thrombolysis was complete, this filter will need to be retrieved and repositioned in the infra renal inferior vena cava.After, two days of post deployment, an inferior vena cavagram was performed for follow up on deep vein thrombosis.The study showed that there remained small residual thrombus in the infra renal inferior vena cava as well within the suprarenal inferior vena cava filter.After, twenty-two days later, the bard g2 x filter was attempted for removal.The right internal jugular vein was accessed and a 5- french flush catheter was advanced.An inferior vena cavagram was performed and the catheter was then exchanged over a bentson wire for a retrieval sheath.The hook of the filter device was embedded in the wall of the cava and there was significant tilt of the filter device with some of the filter legs protruded into the left renal vein.Also, a small amount of thrombus was present within the filter.The hook of the device could not be engaged and therefore, the sheath was exchanged over a wire of a 16-french sheath.Then, a s0s catheter was placed below the inferior vena cava filter and the filter device was engaged using the loop snare technique.With traction, the filter did not straighten due to the hook being embedded within the wall.Therefore, further attempts to retrieve the filter were abandoned.Finally, it was concluded that the inferior vena cava filter was tilted with the hook embedded within the wall and despite multiple attempts, the filter could not be successfully retrieved.Around, three week later, a computed tomography of abdomen and pelvis was performed for abdominal pain, back pain and inferior vena cava filter evaluation.The study showed that an inferior vena cava filter was identified above the level of the renal veins and the most inferior aspect of the filter was noted terminated at the level of the renal veins.Also, previously noted limbs of the filter extended into the left renal vein were no longer noted within the left renal vein and reside within the inferior vena cava.Also, the superior aspect of the filter was indiscernible from the inferior vena cava wall on the right.On the same day the bard g2 x inferior vena cava filter was attempted for retrieval.The right jugular vein was accessed, and a 5-french catheter was placed into the infra renal inferior vena cava.A fluoroscopy was performed which demonstrated prominent tilt of the filter with the hook apparently presumably outside of the lumen of the inferior vena cava or tenting it.Also, some of the legs projected into the left renal vein and there was a small amount of clot near the left apex estimated to be less than 20% of the volume of the filter.Then a 11-french sheath and a cook retrieval set was exchanged.However, attempts to retrieve the hook of the filter were not successful due to the tilt.At this point, given its location and possible propensity to cause thrombus, it was elected to attempt more aggressive measures to remove the filter.Manipulation was done just below the neck of the filter per prior literature case reports of difficult filter retrieval and a kumpe catheter was used and a guidewire going from posterior to anterior for access for balloon placement to dislodge the hook.However, when attempts were made subsequently to retrieve the hook of the filter, they remained unsuccessful.At this point, a 16 french sheath was exchanged, and a decision was made to use a loop technique.An s0s catheter was placed into the infra renal cava and used to hook from right to left the filter.Then a guidewire was advanced through its lumen and subsequently through the 16 french sheath, a snare catheter was advanced side by side from the guidewire through the sos catheter.The guidewire was then snared and pulled out through the sheath so that complete loop access was obtained through the filter.Based on imaging in multiple planes, it appeared that the loop was both to the left and the right side of the neck of the filter and should provide good access.Then an 8-french sheath was then advanced over both guidewires and an attempt was made to retrieve.At this point, the filter did retract slightly into the sheath, but due to the tilting, a portion of the hook was unable to snare into the sheath and two of the legs became more deformed and flipped out of the left renal vein into the suprarenal inferior vena cava.Therefore, the attempts were then discontinued.In order to try to straighten the inferior vena caval filter which now appeared slightly more torqued, it was elected to gain access to the left common femoral vein, as the right common femoral vein has known deep vein thrombosis.Now the common femoral vein was accessed micro puncture needle was advanced into the left femoral vein and a guidewire advanced through the lumen.Then a sos omni catheter was used and attempted to free some of the legs down back into the inferior vena cava and was able to free one of the two, but the other remained in the super renal cava.At this point, it was felt that possibly a through-and through wire from the groin to neck access may assist in straightening the filter.Then a manipulation was made around the right side of the filter and was able to snare it from the jugular sheath, given a long amplatz guidewire which would serve as a through-and-through access.Unfortunately, this did not straighten the filter and further attempts to retrieve were unsuccessful.Then contrast was injected from the groin sheath to assess the filter, and this demonstrated there was some irregularity around the filter itself and the filter appeared slightly more torqued than prior and one of the legs extended superiorly into the suprarenal inferior vena cava.Also, the legs do appear out of the renal veins though.Finally, it was concluded as unable to remove the filter due to tilt and the legs appeared out of the left renal vein now, but one is torqued in the suprarenal inferior vena cava.Around, three years later, a computed tomography of abdomen and pelvis was performed for faux pulmonary embolism post inferior vena cava filter placement.The study showed a bird¿s nest inferior vena cava filter was in place and some of its components do extend outside of the inferior vena cava but there was no evidence of thrombus within the inferior vena cava.Around, six years and seven months later, a computed tomography of abdomen and pelvis was performed for evaluation of inferior vena cava filter.The study showed an inferior vena cava filter was present just above and at the level of the renal veins.The study also showed that the main filter appeared to the with its tip directed superiorly into the right approximately 30 to 40 degrees relative to the inferior vena cava and the tip appeared to extend outside the wall of the inferior vena cava adjacent to the right adrenal gland.Also, several struts perforated the wall of the inferior vena cava with no surrounding fluid collections and one of the struts seems to be fractured or bent and was turned superiorly ending in the inferior vena cava within the liver.Therefore, an angulated filter as one strut unusually positioned/angulated extended superiorly and other features as above.Therefore, the investigation is confirmed for positioning problem, perforation of the inferior vena cava (ivc), material deformation, filter tilt and retrieval difficulties.Per medical records, multiple attempts were made to engage the apex of the filter using snare were unsuccessful due to filter tilt, material deformation and embedment.This could have contributed to the retrieval difficulties.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.(expiry date: 12/2012).

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.At some time post filter deployment, it was alleged that the filter tilted and embedded in the wall of inferior vena cava.The device has not been removed after two attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

Manufacturer Narrative

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.Bard g2 x filter was deployed in the suprarenal inferior vena cava for a patient with right lower extremity deep vein thrombosis.A venogram was performed prior deployment which showed there was a large caval thrombus noted extended up to the level of the renal vein inflow.So, therefore, the inferior vena cava filter was deployed in the suprarenal inferior vena cava.Post deployment study showed successful placement of suprarenal inferior vena cava filter.However, once thrombolysis was complete, this filter will need to be retrieved and repositioned in the infra renal inferior vena cava.After, two days of post deployment, an inferior vena cavagram was performed for follow up on deep vein thrombosis.The study showed that there remained small residual thrombus in the infra renal inferior vena cava as well within the suprarenal inferior vena cava filter.After, twenty-two days later, the bard g2 x filter was attempted for removal.The right internal jugular vein was accessed and a 5- french flush catheter was advanced.An inferior vena cavagram was performed and the catheter was then exchanged over a bentson wire for a retrieval sheath.The hook of the filter device was embedded in the wall of the cava and there was significant tilt of the filter device with some of the filter legs protruded into the left renal vein.Also, a small amount of thrombus was present within the filter.The hook of the device could not be engaged and therefore, the sheath was exchanged over a wire of a 16-french sheath.Then, a s0s catheter was placed below the inferior vena cava filter and the filter device was engaged using the loop snare technique.With traction, the filter did not straighten due to the hook being embedded within the wall.Therefore, further attempts to retrieve the filter were abandoned.Finally, it was concluded that the inferior vena cava filter was tilted with the hook embedded within the wall and despite multiple attempts, the filter could not be successfully retrieved.Around, three week later, a computed tomography of abdomen and pelvis was performed for abdominal pain, back pain and inferior vena cava filter evaluation.The study showed that an inferior vena cava filter was identified above the level of the renal veins and the most inferior aspect of the filter was noted terminated at the level of the renal veins.Also, previously noted limbs of the filter extended into the left renal vein were no longer noted within the left renal vein and reside within the inferior vena cava.Also, the superior aspect of the filter was indiscernible from the inferior vena cava wall on the right.On the same day the bard g2 x inferior vena cava filter was attempted for retrieval.The right jugular vein was accessed, and a 5-french catheter was placed into the infra renal inferior vena cava.A fluoroscopy was performed which demonstrated prominent tilt of the filter with the hook apparently presumably outside of the lumen of the inferior vena cava or tenting it.Also, some of the legs projected into the left renal vein and there was a small amount of clot near the left apex estimated to be less than 20% of the volume of the filter.Then a 11-french sheath and a cook retrieval set was exchanged.However, attempts to retrieve the hook of the filter were not successful due to the tilt.At this point, given its location and possible propensity to cause thrombus, it was elected to attempt more aggressive measures to remove the filter.Manipulation was done just below the neck of the filter per prior literature case reports of difficult filter retrieval and a kumpe catheter was used and a guidewire going from posterior to anterior for access for balloon placement to dislodge the hook.However, when attempts were made subsequently to retrieve the hook of the filter, they remained unsuccessful.At this point, a 16 french sheath was exchanged, and a decision was made to use a loop technique.An s0s catheter was placed into the infra renal cava and used to hook from right to left the filter.Then a guidewire was advanced through its lumen and subsequently through the 16 french sheath, a snare catheter was advanced side by side from the guidewire through the sos catheter.The guidewire was then snared and pulled out through the sheath so that complete loop access was obtained through the filter.Based on imaging in multiple planes, it appeared that the loop was both to the left and the right side of the neck of the filter and should provide good access.Then an 8-french sheath was then advanced over both guidewires and an attempt was made to retrieve.At this point, the filter did retract slightly into the sheath, but due to the tilting, a portion of the hook was unable to snare into the sheath and two of the legs became more deformed and flipped out of the left renal vein into the suprarenal inferior vena cava.Therefore, the attempts were then discontinued.In order to try to straighten the inferior vena caval filter which now appeared slightly more torqued, it was elected to gain access to the left common femoral vein, as the right common femoral vein has known deep vein thrombosis.Now the common femoral vein was accessed micro puncture needle was advanced into the left femoral vein and a guidewire advanced through the lumen.Then a sos omni catheter was used and attempted to free some of the legs down back into the inferior vena cava and was able to free one of the two, but the other remained in the super renal cava.At this point, it was felt that possibly a through-and through wire from the groin to neck access may assist in straightening the filter.Then a manipulation was made around the right side of the filter and was able to snare it from the jugular sheath, given a long amplatz guidewire which would serve as a through-and-through access.Unfortunately, this did not straighten the filter and further attempts to retrieve were unsuccessful.Then contrast was injected from the groin sheath to assess the filter, and this demonstrated there was some irregularity around the filter itself and the filter appeared slightly more torqued than prior and one of the legs extended superiorly into the suprarenal inferior vena cava.Also, the legs do appear out of the renal veins though.Finally, it was concluded as unable to remove the filter due to tilt and the legs appeared out of the left renal vein now, but one is torqued in the suprarenal inferior vena cava.Around, three years later, a computed tomography of abdomen and pelvis was performed for faux pulmonary embolism post inferior vena cava filter placement.The study showed a bird¿s nest inferior vena cava filter was in place and some of its components do extend outside of the inferior vena cava but there was no evidence of thrombus within the inferior vena cava.Around, six years and seven months later, a computed tomography of abdomen and pelvis was performed for evaluation of inferior vena cava filter.The study showed an inferior vena cava filter was present just above and at the level of the renal veins.The study also showed that the main filter appeared to the with its tip directed superiorly into the right approximately 30 to 40 degrees relative to the inferior vena cava and the tip appeared to extend outside the wall of the inferior vena cava adjacent to the right adrenal gland.Also, several struts perforated the wall of the inferior vena cava with no surrounding fluid collections and one of the struts seems to be fractured or bent and was turned superiorly ending in the inferior vena cava within the liver.Therefore, an angulated filter as one strut unusually positioned/angulated extended superiorly and other features as above.Therefore, the investigation is confirmed for positioning problem, perforation of the inferior vena cava (ivc), material deformation, filter tilt and retrieval difficulties.Per medical records, multiple attempts were made to engage the apex of the filter using snare were unsuccessful due to filter tilt, material deformation and embedment.This could have contributed to the retrieval difficulties.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.(expiry date: 12/2012).

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.At some time post filter deployment, it was alleged that the filter tilted and embedded in the wall of inferior vena cava.The device has not been removed after two attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

• Brand Name: G2 X FILTER SYSTEM - JUGULAR
• 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: 13556743
• MDR Text Key: 285938183
• Report Number: 2020394-2022-90088
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082305
• 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
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF400J
• Device Lot Number: GFTK3494
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/18/2022
• 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, PLAVIX, LEXAPRO, NEXIUM; TOPAMAX, TEGRETOL AND LEQAQUIN
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Race: White