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

Model Number DL900F

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423)

Patient Problems Pulmonary Embolism (1498); Swelling (2091); Thrombosis (2100); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 08/18/2015

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 with a history of hypercoagulable state and pulmonary embolism was scheduled for placement of an inferior vena cava filter.The right groin was prepped and draped in the usual sterile fashion.Ultrasound guidance was used to access the right femoral vein.A glidewire was advanced into the vena cava.The l3 disc was identified and marked.Injection venography was performed and the renal veins were identified.Ivc filter was then deployed below the renal veins.The sheath and catheter were removed and hemostasis was achieved with manual pressure.The patient tolerated the procedure well.Approximately four months post filter deployment, the patient was admitted to the emergency department with complaint of leg swelling and was diagnosed with acute venous embolism and thrombosis of the lower extremity, and pulmonary embolism.The following day, the patient underwent initiation of catheter-assisted thrombolysis.Venography identified extensive deep vein thrombosis (dvt) involving the left femoral and iliac veins, right iliac vein, and the inferior vena cava with near total occlusion of the previously placed inferior vena cava filter.The next day, resumption of thrombolytic therapy and catheter-assisted thrombolysis resulted in resolution of the left femoral dvt by 90% with occlusion of the ivc up to the filter.The next day, pharmacomechanical rheolytic thrombectomy provided significant improvement in the thrombus burden within the involved vessel, with near complete resolution in the femoral and iliac veins, but with residual thrombus within the ivcf less than 25%.The patient was discharged five days post admission in stable condition.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: neither the device nor images were provided.Medical records were returned.The filter was deployed below the renal veins.Four months later the patient was admitted with venous embolism, thrombosis of the lower extremity, and pulmonary embolism.It was reported that the ivc filter had near total occlusion.Therapy was performed to resolve the occlusion.Based on the medical records received and reviewed, pulmonary embolism after implantation and occlusion at the level of the filter can be confirmed.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/possible complications: do not attempt to remove the denali filter if significant amount of thrombus are trapped within the filter or if the filter snare hook is embedded within the vena cava wall; acute or recurrent pulmonary embolism.This has been reported despite filter usage.It is not known if thrombi passed through the filter, or originated from superior or collateral vessels; deep vein thrombosis; caval thrombosis/occlusion; occlusion of small vessels.All of the above complications may be associated with serious adverse events such as medical intervention.(b)(4).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

Medical records were received and reviewed.Approximately four months post vena cava filter deployment, the patient was admitted to the emergency department with complaint of leg swelling and was diagnosed with deep venous thrombosis of the lower extremity and pulmonary embolism.Imaging identified near total occlusion of the ivc filter.Pharmacomechanical rheolytic thrombectomy performed resulted in near complete resolution in the femoral and iliac veins, but with residual thrombus within the ivc filter less than 25%.The patient was discharged five days post admission in stable condition.No additional information surrounding this event was provided in the medical records received.

Manufacturer Narrative

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.Approximately four months post filter deployment, the patient was admitted to the emergency department with complaint of leg swelling and was diagnosed with acute venous embolism and thrombosis of the lower extremity, and pulmonary embolism.The following day, the patient underwent initiation of catheter-assisted thrombolysis.Venography identified extensive deep vein thrombosis (dvt) involving the left femoral and iliac veins, right iliac vein, and the inferior vena cava with near total occlusion of the previously placed inferior vena cava filter.The next day, resumption of thrombolytic therapy and catheter-assisted thrombolysis resulted in resolution of the left femoral dvt by 90% with occlusion of the inferior vena cava up to the filter.The next day, pharmacomechanical rheolytic thrombectomy provided significant improvement in the thrombus burden within the involved vessel, with near complete resolution in the femoral and iliac veins, but with residual thrombus within the inferior vena cava filter less than 25%.Therefore, the investigation is confirmed for the alleged filter occlusion.Additionally, it can be confirmed that the patient experienced pulmonary embolism (pe) 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.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 approximately four months post vena cava filter deployment, the patient was admitted to the emergency department with complaint of leg swelling and was diagnosed with deep venous thrombosis of the lower extremity and pulmonary embolism.Imaging identified near total occlusion of the ivc filter.Pharmacomechanical rheolytic thrombectomy performed resulted in near complete resolution in the femoral and iliac veins, but with residual thrombus within the ivc filter less than 25%.The patient was discharged five days post admission in stable condition.

• 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: 6268082
• MDR Text Key: 65453880
• Report Number: 2020394-2017-00009
• 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
• Report Date: 05/26/2022

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: 03/31/2018
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFZC0095
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/20/2017
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2015
• 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: METOPROLOL 25MG, WARFARIN 4MG, CEPHALEXIN 500MG.; METOPROLOL 25MG, WARFARIN 4MG, CEPHALEXIN 500MG.; METOPROLOL 25MG, WARFARIN 4MG, CEPHALEXIN 500MG
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention; Other
• Patient Age: 33 YR
• Patient Sex: Female