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

Catalog Number DL900F

Device Problems Difficult to Remove (1528); Positioning Problem (3009); Activation Failure (3270)

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

Event Date 06/14/2021

Event Type  malfunction  

Event Description

It was reported through the litigation process that a vena cava filter was deployed successfully in a patient with deep vein thrombosis.During deployment, it was found that the filter was allegedly deployed in an unsatisfactory position and the filter did not open well.It was further reported that the filter was allegedly not able to remove.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the reported lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.During deployment, repeat angiography demonstrated the filter was not satisfactory position.In fact, it was located in the sidewall of the inferior vena cava and did not open well, tried then to retrieve and reposition from the jugular vein approach.Jugular access was gained and passed a wire into distal inferior vena cava.A snare was deployed; it was not in the same plane as the filter and unable to retrieve the filter.Examination with fluoroscopy has been done, and do not believe that it was harmful, so we chose to leave it in place.I did not want to place another due to the difficulties and unlikelihood that we would attempt further procedures on the left leg.Therefore, the investigation is confirmed for the reported positioning failure, activation failure during expansion and difficult to remove.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ 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.H3 other text : device not returned.

• Brand Name: DENALI FEMORAL SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 18675098
• MDR Text Key: 334955780
• Report Number: 2020394-2024-00184
• 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,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DL900F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2024
• 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: 50 YR
• Patient Sex: Female