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

Catalog Number DL900J

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423)

Patient Problems Edema (1820); Pain (1994); Thrombosis (2100)

Event Date 08/28/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for occlusion 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: contraindications for use: the denali vena cava filter should not be retrieved if significant thrombus is in or near the filter.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.(b)(6).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the patient allegedly experienced pain, leg swelling, and prominence of the veins on their abdomen.Furthermore, the patient allegedly had a doppler ultrasound that discovered that the patient had extensive dvt in the entire course of the bilateral lower extremity deep venous systems, with a mixture of occlusive and non-occlusive dvt in the right common femoral veins and right popliteal vein.There was an initial attempted but unsuccessful percutaneous removal procedure.The device was removed percutaneously.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, ten months of post deployment, the patient underwent attempted filter retrieval, but the filter could not be removed due to chronic ilio-caval thrombosis at the level of the filter.The patient underwent ilio-caval revascularization for an embedded and chronically thrombosed filter.Around, four months later, the patient presented for filter retrieval, a 12-20 mm trilobed snare was then inserted through the right internal jugular sheath and used to engage the filter hook.Despite 6 lbs of tension, the filter could not be sheathed.A 12 french laser sheath was calibrated and advanced over the snare wire to the point of resistance.The laser sheath was activated to ablate through the scar tissue, and the filter was successfully removed using 3 pounds of tension.Therefore, the investigation is confirmed for retrieval difficulties.However, the investigation is inconclusive for occlusion of the inferior vena cava.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.The current instructions for use states: contraindications for use: the denali vena cava filter should not be retrieved if significant thrombus is in or near the filter.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 in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the patient allegedly experienced pain, leg swelling, and prominence of the veins on their abdomen.Furthermore, the patient allegedly had a doppler ultrasound that discovered that the patient had extensive dvt in the entire course of the bilateral lower extremity deep venous systems, with a mixture of occlusive and non-occlusive dvt in the right common femoral veins and right popliteal vein.There was an initial attempted but unsuccessful percutaneous removal procedure.The device was removed percutaneously.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
• MDR Report Key: 8065004
• MDR Text Key: 126960559
• Report Number: 2020394-2018-02009
• Device Sequence Number: 1
• Product Code: DTK
• 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: 12/06/2020

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 Catalogue Number: DL900J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 11/26/2020
• Supplement Dates FDA Received: 12/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN
• Patient Outcome(s): Other
• Patient Age: 53 YR