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

Catalog Number UNKNOWN FILTER

Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported that post filter placement procedure, the legs of the filter allegedly detached and lodged in to the patient's blood vessel wall.It was further reported that the physician left the device inside the patient and mentioned that the device will not cause any complication.The patient's current status was unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned.One computed tomography abdomen/pelvis and one x-ray lumbar spine images were provided and reviewed.In the computed tomography scan, an inferior vena cava filter is visualized below the renal veins in a satisfactory position in the inferior vena cava.The filter struts appear to extend outside the inferior vena cava and the anterior-medial struts are in close proximity to the aortic bifurcation.The posterior struts protrude close to the spine (l5 vertebra) and the right psoas muscle.In the x-ray, an inferior vena cava filter is visualized in these films as well.The tip of the filter is located approximately at the level of the l4/l3 vertebral body.On review of the multiple projections, it appears that at least one of the filter legs is completely fractured from the device.Based on the image review, the reported detachment and the identified perforation issues can be confirmed as it was noted that one of the filter legs has fractured and the filter legs have protruded through the inferior vena cava.A definitive root cause for the reported detachment and identified perforation issues 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 post filter placement procedure, the legs of the filter allegedly detached and lodged in to the patient's blood vessel wall.It was further reported that the physician left the device inside the patient and mentioned that the device will not cause any complication.The patient's current status was unknown.

• Brand Name: VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12292195
• MDR Text Key: 265544058
• Report Number: 2020394-2021-01433
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN FILTER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention