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

Model Number DL900J

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 06/2018).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with morbid obese, bilateral pulmonary emboli and left leg deep vein thrombosis.Approximately three years and one month post filter deployment, a computed tomography (ct) abdomen without intravenous contrast revealed that the filter tilted and struts perforated the inferior vena cava wall.The device was removed percutaneously.The patient reportedly experienced left-sided abdominal pain; however, the current status of the patient is unknown.

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 same day, the patient presented with left-sided abdomen pain.Approximately 3 months and 29 days post filter deployment, computed tomography revealed there was a filter within the inferior vena cava.Around 2 years and 9 months later, computed tomography revealed there was some slight posterior tilt of the superior aspect of the inferior vena cava filter noted.There was 1 strut along the ventral wall, which extended beyond the lumen of the inferior vena cava.The 1 strut beyond the lumen measured approximately 7 mm beyond the lumen.After 4 months and 10 days, an attempt was made to retrieve the filter.A bard filter retrieval snare was maneuvered around the hook and the inferior vena cava filter was recovered into the 12 french sheath.The 9 french sheaths involving the filter was then removed.The filter was inspected and had all 6 six arms and 6 legs.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).However, the investigation is inconclusive for filter tilt as the medical record states ¿some slight posterior tilt of the superior aspect of the inferior vena cava filter noted¿.Based upon the available information, the definitive root cause is unknown.Labeling review: instructions for use: precautions: the safety and effectiveness of this device has not been established for morbidly obese patients.Abdominal procedures such as bariatric surgery may affect the integrity and stability of 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.H10: d4(expiry date: 06/2018),g3.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 morbid obese, bilateral pulmonary emboli and left leg deep vein thrombosis.Approximately three years and one month post filter deployment, a computed tomography (ct) abdomen without intravenous contrast revealed that the filter tilted and struts perforated the inferior vena cava wall.The device was removed percutaneously.The patient reportedly experienced left-sided abdominal pain; 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
• MDR Report Key: 11357238
• MDR Text Key: 232782629
• Report Number: 2020394-2021-80181
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• 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: GFZE3710
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BUSPIRONE HYDROCHLORIDE, FUROSEMIDE AND IBUPROFEN; BUSPIRONE HYDROCHLORIDE, FUROSEMIDE AND IBUPROFEN; FENOFIBRATE AND LEFLUNOMIDE; FENOFIBRATE AND LEFLUNOMIDE; LISINOPRIL, LYRICA AND MONTELUKAST SODIUM; LISINOPRIL, LYRICA AND MONTELUKAST SODIUM; PERCOCET, PANTOPRAZOLE SODIUM AND PREDNISONE; PERCOCET, PANTOPRAZOLE SODIUM AND PREDNISONE; XELJANZ, TRAMADOL, LYRICA AND COUMADIN; XELJANZ, TRAMADOL, LYRICA AND COUMADIN; BUSPIRONE HYDROCHLORIDE, FUROSEMIDE AND IBUPROFEN; FENOFIBRATE AND LEFLUNOMIDE; LISINOPRIL, LYRICA AND MONTELUKAST SODIUM; PERCOCET, PANTOPRAZOLE SODIUM AND PREDNISONE; XELJANZ, TRAMADOL, LYRICA AND COUMADIN
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 118