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

Model Number DL900F

Device Problems Positioning Problem (3009); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2022

Event Type  Death  

Event Description

It was reported that during a deployment of a vena cava filter, the filter allegedly "tumbled" through the patients ventricle then in the the pulmonary artery, where if finally deployed.It was further reported that that filter was removed and another manufactures filter was used to complete the procedure.At the conclusion of the procedure, the patient was reported as stable; however, it was then reported that the patient expired (7) days later.The relationship between the filter deployment event and the death is unknown.

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation of the reported event is currently underway.(expiry date: 04/2025).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.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one denali femoral delivery system was returned for evaluation with the pusher catheter inserted through the touhy and exiting out the distal end of the storage tube.No filter was returned.Dimensional analysis was performed on the returned delivery system.The device met all specifications.Images and medical records were not provided.The investigation is inconclusive for the reported positioning problem and filter migration issue as there is no clear evidence provided to confirm the alleged issue.A definitive root cause for the reported positioning problem and filter migration could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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 that during a deployment of a vena cava filter, the filter allegedly "tumbled" through the patients ventricle then in the pulmonary artery, where if finally deployed.It was further reported that filter was removed and another manufactures filter was used to complete the procedure.At the conclusion of the procedure, the patient was reported as stable; however, it was then reported that the patient expired (7) days later.The relationship between the filter deployment event and the death is unknown.

• Brand Name: DENALI VENA CAVA FILTER
• Type of Device: FILTERS
• 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 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15675555
• MDR Text Key: 302447685
• Report Number: 2020394-2022-00840
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

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: GFGQ1780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2022
• 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
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Sex: Male