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

Model Number DL900F

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 05/09/2018

Event Type  Injury  

Manufacturer Narrative

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.Medical records were provided and reviewed.Bard denali retrievable filter was deployed with the tip of the catheter at the l1-l2 disc space in a patient with deep vein thrombosis.The filter deployed well with no tilt identified.Approximately one year and nine months of post deployment, computerized tomography-abdomen was performed which showed that appropriate inferior vena cava filter position with minimal transmural protrusion of filter struts anteriorly and to the left.The long axis of the filter was within 5 degrees of the inferior vena cava long axis.The tip of the filter does not contact the inferior vena cava walls.A metallic inferior vena cava filter with 12 struts was oriented longitudinally in the inferior vena cava.The tip of the filter was located 1.5 cm below the renal veins.There was no visible fracture or deformity of the metallic struts.In the axial plane, a strut at the 12:00 position protrudes 2 mm through the anterior inferior vena cava wall, contacting but not penetrating the posterior wall of the transverse duodenum.Struts at the 2:00 and 3:00 positions protrude 3 mm.The inferior vena cava wall, contacting but not penetrating abdominal aorta.There is no retroperitoneal hematoma or fibrosis, and no evidence of filter migration.One year and nine months earlier, the patient presented with lower abdominal pain.Also noted to had protrusion of the filter struts however remains in appropriate position.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc).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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter strut perforated the inferior vena cava wall and contacting the abdominal aorta.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• 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: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12075339
• MDR Text Key: 258634586
• Report Number: 2020394-2021-80531
• 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
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• 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
• Treatment: ASPIRIN, MIRTAZAPINE, BUMETANIDE, LEVOTHYROXINE; BUSPIRONE, MONTELUKAST, OMEPRAZOLE; CHROMIUM PICOLINATE, LOVENOX, ZOFRAN; COQ10, FISH OIL, LISINOPRIL, REMERON; HYDROCODONE, DULCOLAX, MIRALAX; LORTAB, SERTRALINE, POTASSIUM CHLORIDE, PREMARIN; PRAVASTATIN, TOPAMAX; SINGULAIR, ZOLOFT, VITAMIN B12, MELOXICAM; THEOPHYLLINE, TOPIRAMATE, CLONAZEPAM; XARELTO, ZYRTEC, MELATONIN, MULTIVITAMIN
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 91