MAUDE Adverse Event Report: DENALI FEMORAL SYSTEM; VENA CAVA FILTER

Model Number DL900F

Device Problems Difficult to Remove (1528); Malposition of Device (2616)

Patient Problems Edema (1820); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2016

Event Type  malfunction  

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 with history of deep venous thrombosis and pulmonary embolus was scheduled for filter placement prior to orthopedic surgery.The right femoral vein was accessed and a cavogram identified the renal veins.The filter was advanced and deployed at l2-l3 below the level of the renal veins.Completion venogram demonstrated excellent deployment of the filter without any complications.The patient tolerated the procedure well.Approximately two months post filter deployment, the patient was schedule for filter retrieval.The right internal jugular vein was accessed and a cavogram demonstrated a filter in place without any evidence of extravasation or filling defects.Multiple attempts were made with a snare to retrieve the filter, but were unsuccessful.The decision was made to leave the filter in place.The patient tolerated the procedure well without any complication.The patient presented for a cardiology consult approximately five months post filter deployment for evaluation of lower extremity edema following hip replacement.Review of venous doppler scan demonstrated reflux in the bilateral great saphenous veins, but it was unclear if there was any reflux in the deep veins.There was concern that the filter may be contributing to lower extremity edema, and venous doppler was to be repeated.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was not returned.Images were not provided.Medical records were provided and reviewed.A vena cava filter was successfully deployed below the renal veins.Two months post filter deployment, multiple attempts were made to snare the filter, however the filter could not be removed and remained implanted.Based on the provided medical records, the investigation can be confirmed for difficulties removing the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings: - remove the denali filter using an intravascular loop snare only.Precaution: - the retrieval of the denali® filter should only be performed using minimum 9f i.D./11f i.D.Dual retrieval sheaths.Misuse of these devices or improper retrieval technique may result in intimal injury or caval narrowing.Procedural instructions: - prior to use, remove the retrieval sheaths from their packaging and flush them with heparinized saline or suitable isotonic solution.- introduce and advance the 11f retrieval sheath with dilator over the guidewire.- remove the 11f dilator.Introduce and advance the 9f retrieval sheath with dilator over the guidewire such that the tip of the sheath is approximately 3cm cephalad to the filter snare hook.- insert and advance the intravascular snare assembly through the 9f retrieval sheath until it protrudes out such that the marker band of the snare catheter is cephalad to the filter snare hook.- the retrieval of the denali filter using an intravascular snare is illustrated in the instructions for use.Note: always maintain tension on the snare to prevent disengagement of the snare loop from the filter snare hook.Note: it is possible that complications such as those described in the ¿warnings¿, ¿precautions¿, or ¿potential complications¿ sections of this instructions for use may affect the recoverability of the device and result in the clinician¿s decision to have the device remain permanently implanted.Precaution: care should be taken when advancing the 9f retrieval sheath in the caudal direction to avoid completely covering the arms and legs.

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 received.Patient status was not provided.New information received: medical records were received and reviewed.Approximately two months post filter deployment, the patient presented for filter retrieval.The right internal jugular vein was accessed and multiple unsuccessful retrieval attempts were made with a snare.The decision was made to leave the filter in place.The patient tolerated the procedure well.Approximately five months post filter deployment, patient presented for evaluation of lower extremity edema.Venous doppler scan demonstrated bilateral great saphenous vein reflux, but it was unclear in there was reflux in the deep vein.There was concern the filter may have contributed to the lower extremity edema and the venous doppler scan was to be repeated.No additional information was provided in the medical records received.

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.On the next day of post deployment, a follow up was made with the patient through telephone regarding inferior vena cava filter insertion.The patient stated no experience of pain out of proportion and denied fever, chills or other symptoms at the time.The patient was feeling well.After two months, through the right internal jugular vein approach, the bard denali inferior vena cava filter was attempted to remove.A cook needle was introduced percutaneously into the right internal jugular vein and a wire was advanced without any difficulty.Then an 8 french sheath was advanced over the obturator and the wire into the inferior vena cava.Subsequently the snare was introduced through the sheath.Multiple attempts were made at snaring the inferior vena cava filter and were unsuccessful.Finally, it was decided to keep the filter in place.Post vena cavogram showed that the inferior vena cava filter was in place without any evidence of extravasation or blood clots or filling defects.After one month, the patient was referred for vascular consultation.The patient reported experiencing edema to the knees and the edema was slightly improved with elevation.The past history of the patient revealed that the patient had an inferior vena cava filter placement and also had an unsuccessful attempt of removal of the filter.So, it was unknown whether the patient has venous insufficiency bilaterally, secondary to the filter or the patient have acquired lymphedema in both lower extremities.However, the venous duplex examination showed that there was severe reflux noted in the bilateral great saphenous veins with compression maneuvers.After one month, the patient reported that the edema has gotten worse and has persistent left leg pain.It was found that the chronic lower extremity edema might be associated with great saphenous vein reflux, status post inferior vena cava filter.After one week, the patient presents for evaluation due to severe lower extremity edema and this has been a chronic problem.It was discussed with the patient that there was a concern rather the inferior vena cava filter may be contributing to her lower extremity edema.Therefore, the investigation is confirmed for the alleged retrieval difficulties.However, the investigation is inconclusive for the alleged filter tilt.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.H10: b6,b7,d4(expiry date: 02/2019),d10,g3,h6(device).H11: b5,g1,h6(patient, 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.

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 and in conjunction with or before orthopedic procedure.Approximately two months post filter deployment, the patient presented for filter retrieval.The right internal jugular vein was accessed and multiple unsuccessful retrieval attempts were made with a snare.Approximately five months post filter deployment, patient presented for evaluation of lower extremity edema.At some time post filter deployment, it was alleged that the filter tilted and embedded in wall of the inferior vena cava.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

• Brand Name: DENALI FEMORAL SYSTEM
• Type of Device: VENA CAVA FILTER
• MDR Report Key: 6273118
• MDR Text Key: 65609970
• Report Number: 2020394-2017-00010
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801(17)190228(10)GFAN1600
• Combination Product (y/n): N
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFAN1600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2016
• 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: B-12, PANTOPRAZOLE SODIUM; B-12, PANTOPRAZOLE SODIUM, CARTIA AND COUMADIN; FOLIC ACID, LOSARTAN-HYDROCHLOROTHIAZIDE; FOLIC ACID, LOSARTAN-HYDROCHLOROTHIAZIDE; LASIX, CALCIUM+D, DIGOXIN, DILTIAZEM CD; LASIX, CALCIUM+D, DIGOXIN, DILTIAZEM CD; OMEPRAZOLE, ROPINIROLE, WARFARIN, ZANTAC; OMEPRAZOLE, ROPINIROLE, WARFARIN, ZANTAC; B-12, PANTOPRAZOLE SODIUM; FOLIC ACID, LOSARTAN-HYDROCHLOROTHIAZIDE; LASIX, CALCIUM+D, DIGOXIN, DILTIAZEM CD; OMEPRAZOLE, ROPINIROLE, WARFARIN, ZANTAC
• Patient Age: 82 YR
• Patient Weight: 100