MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SNF/SL; VENA CAVA FILTER

Catalog Number UNKNOWN SNF

Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Perforation (2001); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review 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 (ifu) 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.Journal article review: poletti, p.A., becker, c.D., prina, l., ruijs, p., bounameaux, h., didier, d., ¿ terrier, f.(1998).Long-term results of the simon nitinol inferior vena cava filter.European radiology, 8(2), 289¿294.Doi: 10.1007/s003300050382.

Event Description

It was reported in an article from the journal of european radiology titled " long-term results of the simon nitinol inferior vena cava filter " that after the filter placement, recurrent pulmonary embolism (pe) was diagnosed clinically in 2 patients and required log-term anticoagulation, deep venous thrombosis (dvt) of the lower extremities was diagnosed in 3 patients; one of these patients had inferior vena cava (ivc) thrombosis, four patients had confirmed access site thrombosis and required long-term anticoagulation; in 2 of these patients the entire femoral axis was thrombosed.Four patients complained of clinical symptoms consistent with venous insufficiency of the lower limbs.Six filters had fracture of one strut; one patient complained of chronic abdominal pain and a computed tomography (ct) examination revealed perforation of the ivc by filter struts that entered in contact with the aorta and psoas, however, the symptoms disappeared 3 years after filter introduction.The status of the patients was not provided.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a manufacturing review 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 (ifu) 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 in an article from the journal of european radiology titled " long-term results of the simon nitinol inferior vena cava filter " that after the filter placement, recurrent pulmonary embolism (pe) was diagnosed clinically in 2 patients and required log-term anticoagulation, deep venous thrombosis (dvt) of the lower extremities was diagnosed in 3 patients; one of these patients had inferior vena cava (ivc) thrombosis, four patients had confirmed access site thrombosis and required long-term anticoagulation; in 2 of these patients the entire femoral axis was thrombosed.Four patients complained of clinical symptoms consistent with venous insufficiency of the lower limbs.Six filters had fracture of one strut; one patient complained of chronic abdominal pain and a computed tomography (ct) examination revealed perforation of the ivc by filter struts that entered in contact with the aorta and psoas, however, the symptoms disappeared 3 years after filter introduction.The status of the patients was not provided.

• Brand Name: SNF/SL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9517026
• MDR Text Key: 175111902
• Report Number: 2020394-2019-05855
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K970099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN SNF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention