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

Model Number DL900F

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problem Abdominal Pain (1685)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

A 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.After one week post deployment, the patient presented with abdominal pain.After two days, a computed tomography (ct) chest without contrast demonstrated that an inferior vena cava filter was partially visualized.On the next day, a duplex venous leg bilateral showed no evidence of deep vein thrombosis of the veins of the legs.After two years and two weeks later, a computed tomography (ct) abdomen without intravenous or oral contrast showed that there was a vena cava filter and this was tipped approximately 20-degrees medially.The superior aspect of the filter was at the level of the left renal vein superiorly.One of the struts at 9 o¿ clock was 3 mm beyond the wall of the vena cava.One of the struts at 11 o¿ clock was approximately 2 mm beyond the vena cava.None of the struts appeared to extend into adjacent organs.There was no retroperitoneal hematoma.There was no fracture or bending of the struts identified.Therefore, the investigation is confirmed for the alleged filter migration, perforation of the inferior vena cava and filter tilt.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.

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.Approximately two years post vena cava filter deployment a computed tomography scan demonstrated that the filter tilted and perforated.At some time post filter deployment, it was alleged that the filter migrated.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: 12201521
• MDR Text Key: 262623893
• Report Number: 2020394-2021-80665
• 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: 07/21/2021

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: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/21/2021
• 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: MUCINEX, VISTARIL, LEVAQUIN AND PANTOPRAZOLE; PREDNISONE AND DAPTOMYCIN; TYLENOL, DIPHENHYDRAMINE, LOVENOX AND GABAPENTIN
• Patient Outcome(s): Other
• Patient Age: 70 YR