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

Model Number DL900J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2021).Device not returned.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with bilateral femoral vein deep vein thrombosis.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with thrombus above the filter; however, the current status of the patient is unknown.

Manufacturer Narrative

The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device was not returned for evaluation.Medical records were provided and reviewed.Two inferior vena cava filters were deployed due to the large size of the inferior vena cava.Approximately, two months twenty-three days, a computed tomography (ct) abdomen and pelvis with intravenous contrast showed that the inferior vena cava filters were identified within the bilateral common iliac veins, at the level of the confluence of external and internal iliac veins on the right and above the level of the confluence of the left.There was no thrombus in the inferior vena cava or common iliac veins.Around, four months and eleven days later, an attempt was made to retrieve the right iliac vein filter from the patient¿s body.A left iliac venogram demonstrated that a large thrombus was associated with the superior tip of the left iliac vein filter, that extended towards the iliac bifurcation.Due to the adherent thrombus, it was not safe to remove the filter at this time.Through a separated right internal jugular venous access, a 6-french sheath was placed over the wire to the level of the right iliac vein inferior vena cava filter.A right external iliac venogram demonstrated there was no evidence of thrombus associated with the filter.Serial dilation was performed, and the coaxial sheath system was advanced into position just cephalad to the apex of the filter.Despite multiple attempts, the filter apex was unable to be engaged with a 20 mm loop snare.Ultimately, a 6 french sheath was placed over the wire to the level of the right inferior vena cava filter.A vs1 catheter was then formed in the right external iliac vein.It was then attempted to sling the filter with a glidewire.During this maneuver, the patient experienced discomfort and it was decided to abort the procedure.The sheaths were removed, and hemostasis was achieved with manual pressure.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 10/2021).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with bilateral femoral vein deep vein thrombosis.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with thrombus above the filter; however, the current status of the patient is unknown.

• Brand Name: DENALI JUGULAR 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 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11874999
• MDR Text Key: 252346812
• Report Number: 2020394-2021-01100
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

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 Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFCW0246
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2018
• 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: APIXABAN
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 125