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

Catalog Number UNK DENALI

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

H10: (b)(6), (2016).Bard denali filter fractures.Journal of vascular and interventional radiology, 27(7):1099-101.Doi: 10.1016/j.Jvir.2016.04.008.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.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 in an article titled "bard denali filter fractures", that a inferior vena cava filter was deployed successfully, in a patient with left lower extremity deep venous thrombus with subsequent retroperitoneal hemorrhage while anticoagulated.Approximately two hundred and forty two days later post filter deployment, the filter strut detached during retrieval of the filter.It was further reported that the detached strut and filter were successfully retrieved with combination snare for the filter and forceps for the fractured strut.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the detachment could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.Bill s.Majdalany, minhajuddin s.Khaja, and david m.Williams, (2016).Bard denali filter fractures.Journal of vascular and interventional radiology, 27(7): 1099-1101.Doi: 10.1016/j.Jvir.2016.04.008.The information provided by bd represents all 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 in an article in the "journal of vascular and interventional radiology" titled "bard denali filter fractures", that an inferior vena cava filter was deployed successfully in a patient after being diagnosed with left lower extremity deep venous thrombus with subsequent retroperitoneal hemorrhage.Approximately two hundred and forty-two days post a vena cava filter deployment, the filter strut had allegedly detached within a centered filter during retrieval of the filter.Reportedly, the detached filter strut and filter were successfully retrieved with combination of a conventional snare for the filter and forceps for the fractured strut.There was no reported patient injury.

• Brand Name: DENALI FILTER 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 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19030292
• MDR Text Key: 339234165
• Report Number: 2020394-2024-00430
• Device Sequence Number: 1
• Product Code: DTK
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK DENALI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/13/2024
• 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
• Patient Age: 65 YR
• Patient Sex: Female