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

Model Number DL900F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problems Tachycardia (2095); Ventricular Tachycardia (2132); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 05/21/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.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 was at high risk for development of deep venous thrombosis after being involved in a motorcycle accident.The decision was made to place a prophylactic inferior vena cava filter.The right common femoral vein was accessed and a vena cava filter was successfully deployed in an infrarenal location.Approximately eight months post filter deployment, the patient was scheduled for filter retrieval as the filter was no longer needed.The right neck was accessed and a loop snare was used in an unsuccessful attempt to capture the tip of the filter.Contrast injection demonstrated the tip of the filter to be tilted posteriorly with a limb adjacent to the tip.A wire was used to gently pull the filter out of the edge of the ivc and position it in a more central location.The filter was successfully captured with a snare and pulled into the sheath.The detached filter limb then migrated to the right ventricle.Multiple unsuccessful attempts were made to capture the detached limb from the heart before the right groin was accessed.A catheter was used to gain access into the right ventricle and additional unsuccessful retrieval attempts were made trying to capture the detached filter limb.The patient experienced non-sustained runs of ventricular tachycardia that would terminate with the withdrawal of the catheter.Cardiac surgery was consulted and a ct scan was requested to identify the location of the detached limb.Ct scan demonstrated the filter limb migrated out of the heart and into a pulmonary artery branch in the right lower lung.The filter limb was in a safe location and no further intervention was performed.Both sheaths were removed and compression was applied until hemostasis was achieved.The patient was monitored overnight in the icu with telemetry and discharged home the following day.Image/photo review: as medical images were not provided, a review could not be performed.Conclusion: the device was not returned.Images were not received.Medical records were provided.The medical records allege a filter was implanted successfully below the renal veins for risk for development of deep vein thrombosis following a motorcycle accident.Approximately eight months after deployment a retrieval procedure was performed.A snare was allegedly used in an unsuccessful attempt to capture the tip of the filter.Contrast injection demonstrated the filter to be tilted posteriorly with a limb adjacent to the tip.A wire was used to position the filter in a more centralize location.The filter was successfully captured and retrieved with a snare.The detached limb allegedly migrated to the right ventricle.Multiple attempts to retrieve the detached limb were unsuccessful.The right groin was accessed and additional unsuccessful retrieval attempts were made to try and capture the detached limb.Cardiac surgery was consulted and a ct scan was requested.The ct scan allegedly demonstrated the limb in a pulmonary branch of the right lower lung.The limb was determined to be in a safe location and no further intervention was performed.Based on the medical record review, the investigation is confirmed for filter tilt, limb detachment and retrieval difficulties.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.Movement, migration or tilt are known complications of vena cava filters.Filter malposition.Filter tilt.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that 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 eight months post prophylactic filter deployment following a motorcycle accident, the patient was scheduled for filter retrieval.The right neck was accessed and a snare was used in an unsuccessful attempt to capture the tip of the filter.Contrast injection demonstrated the filter to be tilted with a detached limb adjacent to the tip of the filter.A catheter was used to get a wire around the tip of the filter and position in a more central location in the ivc.The filter was then successfully captured with a snare and pulled into the sheath; however, the detached filter limb migrated to the right ventricle.Multiple unsuccessful attempts were made from jugular and femoral access in an effort to retrieve the detached filter limb.Cardiac surgery was consulted and requested a gated ct scan to determine the filter limb location.Ct scan demonstrated the filter limb migrated out of the heart into a safe location in the pulmonary artery.No further intervention was performed.Sheaths were removed and compression was applied until hemostasis was achieved.The patient was monitored over night and discharged the following day.No additional information was provided in the medical records received.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Medical records review: the patient was at high risk for development of deep venous thrombosis after being involved in a motorcycle accident.The decision was made to place a prophylactic inferior vena cava filter.The right common femoral vein was accessed and a vena cava filter was successfully deployed in an infrarenal location.Approximately eight months post filter deployment, the patient was scheduled for filter retrieval as the filter was no longer needed.The right neck was accessed and a loop snare was used in an unsuccessful attempt to capture the tip of the filter.Contrast injection demonstrated the tip of the filter to be tilted posteriorly with a limb adjacent to the tip.A wire was used to gently pull the filter out of the edge of the ivc and position it in a more central location.The filter was successfully captured with a snare and pulled into the sheath.The detached filter limb then migrated to the right ventricle.Multiple unsuccessful attempts were made to capture the detached limb from the heart before the right groin was accessed.A catheter was used to gain access into the right ventricle and additional unsuccessful retrieval attempts were made trying to capture the detached filter limb.The patient experienced non-sustained runs of ventricular tachycardia that would terminate with the withdrawal of the catheter.Cardiac surgery was consulted and a ct scan was requested to identify the location of the detached limb.Ct scan demonstrated the filter limb migrated out of the heart and into a pulmonary artery branch in the right lower lung.The filter limb was in a safe location and no further intervention was performed.Both sheaths were removed and compression was applied until hemostasis was achieved.The patient was monitored overnight in the icu with telemetry and discharged home the following day.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Approximately eight months post deployment a snare was used in an unsuccessful attempt to capture the tip of the filter.Contrast injection demonstrated the filter to be tilted posteriorly with a limb adjacent to the tip.A wire was used to position the filter in a more centralize location.The filter was successfully captured and retrieved with a snare; however, the detached limb migrated to the right ventricle.Multiple attempts to retrieve the detached limb were unsuccessful.The right groin was accessed and additional unsuccessful retrieval attempts were made to try and capture the detached limb.Cardiac surgery was consulted and a ct scan was requested.The ct scan allegedly demonstrated the limb in a pulmonary branch of the right lower lung.The limb was determined to be in a safe location and no further intervention was performed.Based on the medical record review, the investigation is confirmed for filter tilt, limb detachment, and retrieval difficulties.Based upon 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.

Event Description

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 eight months post prophylactic filter deployment following a motorcycle accident, the patient was scheduled for filter retrieval.The right neck was accessed and a snare was used in an unsuccessful attempt to capture the tip of the filter.Contrast injection demonstrated the filter to be tilted with a detached limb adjacent to the tip of the filter.A catheter was used to get a wire around the tip of the filter and position in a more central location in the ivc.The filter was then successfully captured with a snare and pulled into the sheath; however, the detached filter limb migrated to the right ventricle.Multiple unsuccessful attempts were made from jugular and femoral access in an effort to retrieve the detached filter limb.Cardiac surgery was consulted and requested a gated ct scan to determine the filter limb location.Ct scan demonstrated the filter limb migrated out of the heart into a safe location in the pulmonary artery.No further intervention was performed.Sheaths were removed and compression was applied until hemostasis was achieved.The patient was monitored over night and discharged the following day.No additional information was provided in the medical records received.New information received: it was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter tilted and embedded the wall of the ivc.A filter limb detached and migrated through right ventricle and ultimately migrated to the distal right lower lobe pulmonary artery.The device was removed percutaneously.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately eight months later post filter deployment, removal procedure was attempted since the filter was no longer needed.Via the right internal jugular vein, a loop snare was attempted to grab the tip of the inferior vena cava filter unsuccessfully.Direct injection of contrast through the guide catheter for the snare demonstrated the tip of the filter to be in a small lumbar vein branch and tilted posteriorly.One of the arms of the filter was adjacent to the tip of the inferior vena cava filter.An sos catheter was then used to get a bentson wire around the tip of the catheter and then snared the upper end of the wire which was then used to gently pull the filter out of the edge of the inferior vena cava and more centrally located.After this the tip of the inferior vena cava filter grabbed with a snare and pulled the filter into the 10 french sheath.However, the arm that was above the tip of the filter appeared to have been fractured and did not pull completely into the sheath despite multiple attempts.Once the filter was pulled out, the fractured arm had stayed behind the inferior vena cava and immediately floated into the right ventricle.Multiple attempts were made with the pigtail catheter, c-2 catheter and multiple loop snares including a 25 mm loop snare and 15 mm loop snare and clover shaped snare, but this fragment was quite posteriorly in the right ventricle and could not successfully be retrieved from the right ventricle.A 5 french c-2 catheter was then used to gain access into the right ventricle.Further attempts without success from an inferior approach as well as a long shapeable sheath to gain access into the proximal right ventricle from below, again unsuccessfully to retrieve this catheter piece.Cardiac surgery was consulted.It was decided to take the patient to computed tomography scanner which later on revealed a small fragment had migrated completely out of the heart very peripherally into the pulmonary artery branch and to the right lobe in a safe location and no further intervention was felt necessary.The patient had some arrythmia during the procedure that resolved.On the same day, computed tomography imaging of chest without contrast was performed to evaluate inferior vena cava fractured strut location which showed the linear fragment was located in a horizontal branch of the right lower lobe close to the fissure line in the very distal horizontal branch of the pulmonary artery which was small in the right lower lobe near the superior segment.Therefore, the investigation is confirmed for the alleged filter tilt, filter limb detachment and retrieval difficulties.Based on the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.Approximately eight months post prophylactic filter deployment following a motorcycle accident, the patient was scheduled for filter retrieval.The right neck was accessed and a snare was used in an unsuccessful attempt to capture the tip of the filter.Contrast injection demonstrated the filter to be tilted with a detached limb adjacent to the tip of the filter.A catheter was used to get a wire around the tip of the filter and position in a more central location in the inferior vena cava.The filter was then successfully captured with a snare and pulled into the sheath; however, the detached filter limb migrated to the right ventricle.Multiple unsuccessful attempts were made from jugular and femoral access in an effort to retrieve the detached filter limb.Cardiac surgery was consulted and requested a gated computed tomography scan to determine the filter limb location.Computed tomography scan demonstrated the filter limb migrated out of the heart into a safe location in the pulmonary artery.At some time post filter deployment, it was alleged that the filter tilted and embedded the wall of the inferior vena cava.A filter limb detached and migrated through right ventricle and ultimately migrated to the distal right lower lobe pulmonary artery.The device was removed percutaneously.The current status of the patient is unknown.

• Brand Name: DENALI FEMORAL SYSTEM
• 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: 5907079
• MDR Text Key: 53106644
• Report Number: 2020394-2016-00805
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801(17)150531(10)GFXD3887
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2022

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 Expiration Date: 05/31/2015
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFXD3887
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 08/26/2016
• Supplement Dates Manufacturer Received: 12/12/2018; 02/22/2022
• Supplement Dates FDA Received: 01/08/2019; 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2013
• 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: OXYCODONE 5 MG, PROBIOTIC PRODUCT.; OXYCODONE 5 MG, PROBIOTIC PRODUCT.; OXYCODONE 5 MG, PROBIOTIC PRODUCT.; OXYCODONE 5 MG, PROBIOTIC PRODUCT
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 61 KG