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); Patient-Device Incompatibility (2682); Material Deformation (2976); Migration (4003)

Patient Problems Abdominal Pain (1685); Thrombus (2101); Thrombosis/Thrombus (4440)

Event Date 08/09/2016

Event Type  Injury  

Manufacturer Narrative

A lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.The device was not returned for evaluation.Images were not provided.Photo and medical records were provided and reviewed.Post filter deployment approximately five days later, patient was scheduled for filter retrieval.The ivc filter was mal positioned with the retrieval token embedded into the left lateral wall and multiple legs were penetrating in the region of right renal vein.Caval thrombus above the filter extending into the right renal confluence.One of the tines of the filter actually flipped up perpendicular into the right renal vein.Attempts to free the embedded hook was unsuccessful.Approximately four months later, the filter was retrieved successfully.Therefore, the investigation is confirmed for filter tilt, filter limb penetration, retrieval difficulties and material deformation.Additionally, based on the photo review, it can be confirmed that patient underwent open abdominal surgery.Therefore, retrieval difficulties can be confirmed from photo review.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.Per medical records, multiple attempts were made to engage the apex of the filter using snare but were unsuccessful due to filter tilt and embedment.This could have contributed to the retrieval difficulties.However, the definitive root cause is unknown.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: 04/2019), (device: 4001).

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 wall of the ivc and multiple legs penetrated the right renal vein.The device was removed via an open abdominal 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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Images were not provided.Photo and medical records were provided and reviewed.Post filter deployment approximately five days later, patient was scheduled for filter retrieval.The ivc filter was mal positioned with the retrieval token embedded into the left lateral wall and multiple legs were penetrating in the region of right renal vein.Caval thrombus above the filter extending into the right renal confluence.One of the tines of the filter actually flipped up perpendicular into the right renal vein.Attempts to free the embedded hook was unsuccessful.Approximately four months later, the filter was retrieved successfully.Therefore, the investigation is confirmed for filter tilt, retrieval difficulties and material deformation.Based on the photo review, it shows that patient underwent open abdominal surgery.Therefore, the investigation is inconclusive for filter tilt, retrieval difficulties and material deformation.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.Per medical records, attempts was made to retrieve the filter but were unsuccessful due to filter tilt 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: 04/2019.

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 wall of the ivc.The device was removed via an open abdominal procedure after an attempted but unsuccessful retrieval procedure.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.Based on the medical records review, after two days later post filter deployment, a venogram was performed for bilateral deep vein thrombosis.The study showed that an inferior vena cava filter was seen, and no perforation, compression or occlusion were seen.Also, the filter was tilted with the neck and hook of the filter faced the sidewall with some of the arms tilted superiorly.Also, a large thrombus was seen on the top of the vena cava filter, to the cranial side of the filter.An x-ray of abdomen was also performed on the same day for abdominal pain.The study showed that there was an inferior vena cava filter overlaid the mid abdomen slightly angulated with the proximal tip pointed to the left.After two days, the bard denali inferior vena cava filter was attempted for removal with the pre procedural diagnosis mentioned as malpositioned inferior vena cava filter and caval thrombus extended into the right renal vein.During the procedure, the right common femoral vein was accessed, and 4-french sheath was placed.Then an inferior vena cavogram was performed which demonstrated the inferior vena cava filter was tilted with the retrieval token embedded into the left lateral wall and there were several malpositioned legs extended into the region of the right renal vein.Also there was clot burden above the filter extended into the right renal vein confluence.Then a 0.35 wire was advanced along the left lateral margin of the filter and an 8 mm balloon was advanced over the wire and insufflated in an attempt to free the retrieval hook.However, subsequent follow-up again demonstrated the filter tip embedded in the left lateral caval wall.Attempts to free the embedded inferior vena cava filter head from an antegrade approach were unsuccessful as large clot burden above the filter obstructed attempts at retrograde caval access to the retrieval hook.The internal jugular access was not attempted due to the clot burden at the tip of the filter precluded accessing the retrievable hook via right internal jugular access.Finally unable to remove via endovascular methods and surgical removal was recommended.After two weeks, the patient had a follow up visit for bilateral pulmonary embolus that occurred previously.During assessment it was mentioned that there were difficulties with the inferior vena cava filter that had twisted in the vena cava.The patient consulted for removal of the inferior vena cava filter with minimal invasive surgery as the filter had shifted recently.After one month, a computed tomography of abdomen and pelvis was performed for possible migration of the inferior vena cava filter.The study showed that the inferior vena cava was seen with an inferior vena cava filter in place, and it was seen at the level the renal artery.Also, there were two legs of the inferior vena cava filter which extended into the right renal vein.Also, the apex of the inferior vena cava filter was opposed against the left lateral wall and the entire filter was tilted to the left.No obvious extension of leg outside the inferior vena cava was noted.After one month, through exploratory laparotomy with vena caval exploration, the bard denali inferior vena cava filter was removed.An indication was provided which mentioned that the patient had an inferior vena cava filter, and the filter was malpositioned with tines that were flipped into the right renal vein and with clot burden.The patient also had a failed attempt at removal of the filter.During the procedure, the abdomen was prepped, and subcostal kocher incision was made.Then entrance was made into the perineum and retraction was achieved.Then the duodenum and the right colon were all mobilized, and access was gained into the retroperitoneum.Then a venotomy was performed on the anterior surface and the filter was identified.The filter had eroded through the inferior vena cava and into the right renal vein.Also, there were multiple tines that were out of the vena cava and the hook portion was located at the most superior aspect towards the medial aspect near the left renal vein.Also, there was a separate tine that was flipped up perpendicular to the vena cava located into the right renal vein.The filter was then grasped with an empty needle driver and once this was grasped, the tines were pulled out free in sequence in order to complete the removal.All the tines and specimen was removed and placed in a specimen cup off the field as specimen.There were no tines that were broken, and they all appeared to be intact at this time.Finally, the filter was removed, and the vena cava was closed.A surgical pathology report was provided, and the gross description stated that a 5.2 x 4.0 x 3.2 cm umbrella shaped inferior vena cava filter was received and comprised of silver metallic wires measuring 3,5-5.0 cm long, each less than 0.1 cm in diameter.Based on the photo review, it shows that patient underwent open abdominal surgery.Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava, filter migration, filter tilt, material deformation and retrieval difficulties.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.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.H10: b2, b6,b7,d4(expiry date: 04/2019).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 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 wall of the ivc.The device was removed via an open abdominal procedure after an attempted but unsuccessful retrieval procedure.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: brett curtice ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032772
• MDR Report Key: 8835314
• MDR Text Key: 152485917
• Report Number: 2020394-2019-01985
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFAR0078
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2022
• 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: ALTACE, COREG, PREVACID, ZOCOR; NASONEX, NEXIUM, SIMVASTATIN AND ALBUTEROL; NORVASC, COUMADIN, LORTAB, FLEXERIL; OMEPRAZOLE, ETODOLAC, HYDROCHLOROTHIAZIDE
• Patient Outcome(s): Life Threatening; Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White