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

Model Number DL900J

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Medical records review: the patient presented with a history of bilateral pulmonary embolism treated with anticoagulation.The patient developed anemia requiring blood transfusion, and soft tissue hematoma possibly as a complication of anticoagulation; therefore, venous thromboembolism prophylaxis was requested.The right internal jugular vein was accessed and a vena cava filter was deployed in good position.Approximately one year later, the filter was noted to be in place on radiology imaging.No further information is noted regarding the patient¿s current status.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.There was no specific deficiency alleged in the provided medical records.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.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.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 through the litigation process that a vena cava filter was deployed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that a filter strut detached and was found to be lodged in the pulmonary artery.The filter has been removed percutaneously; however, the filter strut remains in the patient.The current patient status is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately one year and one month post deployment, a computed tomography (ct) chest revealed a linear metallic fragment in the branch of right middle lobe pulmonary artery likely related to a migrated filter fragment.Around four days later, the denali filter was removed.A single strut missing from the filter corresponding to the foreign body was seen on computed tomography (ct) imaging.The migrated filter strut was distally lodged in the pulmonary artery and unable to retrieve via endovascular technique.Therefore, the investigation is confirmed for filter limb detachment.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.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 deployed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that a filter strut detached and was found to be lodged in the pulmonary artery.The filter has been removed percutaneously; however, the filter strut remains in the patient.The current patient status is unknown.

• Brand Name: DENALI JUGULAR FILTER
• 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: 7138965
• MDR Text Key: 95803618
• Report Number: 2020394-2017-01788
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 68 KG