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

Catalog Number DL950F

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photo, images and videos were provided for review.The investigation of the reported event is currently underway.The catalog number identified in section has not been cleared in the us but is similar to the denali femoral system products that are cleared in the us.The pro code and 510k number for the denali femoral system products is identified.(expiry date: 04/2023).

Event Description

It was reported that after the filter removal procedure, the leg wire allegedly detached inside the superior vena cava.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One electronic photo and four electronic images were reviewed.The photo shows the filter was kept on the paper.It was noted that the one of the filter leg is missing.There are eleven filter struts were present.Based on the photo review, the reported detachment of device component can be confirmed.Image 1 shows a limited x-ray of the lower thoracic/upper lumbar spine.An ivc filter is in place near the body of the l1 vertebra is likely above the renal veins.Image 2 is a digital subtraction cavogram.The exact anatomic location cannot be determined.One of the filter legs now appears ajar and contorted in an upright position.The third x-ray image shows a denali filter in place.All of the filter legs appear normal in this image.The next image shows a venogram.One of the ivc filter legs appears abnormal and angled cranially.The rest of the filter legs appear normal.Based on the image review, the reported detachment of device component could not be confirmed.However, the investigation is confirmed for the identified material deformation issue based on the image review.Therefore, the investigation is confirmed for the detachment of device or device component and material deformation.A definitive root cause for the alleged detachment of device or device component and identified material deformation could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali femoral system products that are cleared in the us.The pro code and 510k number for the denali femoral system products is identified in d2 and g4.H10: d4 (expiry date: 04/2023), g3, h6 (device, method) 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 after the filter removal procedure, the leg wire allegedly detached inside the superior vena cava.There was no reported patient injury.

• 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
• MDR Report Key: 11853830
• MDR Text Key: 251653238
• Report Number: 2020394-2021-01070
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

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: DL950F
• Device Lot Number: GFER2553
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 08/09/2021
• Supplement Dates FDA Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other