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 Pulmonary Embolism (1498)

Event Date 01/06/2017

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.Approximately one year and five months post filter deployment, computed tomography revealed bilateral filling defects consistent with pulmonary embolism.Filling defects in the distal right main pulmonary artery, as well as small segmental branches of the right and left upper and lower lobes.Approximately one year later, computed tomography revealed the superior margin of the filter was approximately at l1 level and inferior tips were approximately at l3 to l4 disc space.All the inferior extended portion of the filter were at the periphery of the inferior vena cava with the exception of an anterior metallic extension which was anterior to the inferior vena cava.Approximately four months later, the filter was retrieved using standard technique by passing the overlying sheath over the filter.Filter was covered in its entirety, inspected, and the on-table inspection demonstrated 6 arms and legs.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).Additionally, it can be confirmed that the patient experienced pulmonary embolism post deployment.However, the relationship to the filter is unknown.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.At some time post filter deployment, it was alleged that the filter struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with pulmonary embolism post implant; however, 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: 11377125
• MDR Text Key: 233484587
• Report Number: 2020394-2021-80204
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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: 01/29/2021
• 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; ATORVASTATIN, PANTOPRAZOLE, PAXIL, XARELTO; DONEPEZIL, BIOCEF, COUMADIN, LIPITOR, BACLOFEN
• Patient Outcome(s): Life Threatening
• Patient Age: 72 YR
• Patient Weight: 96