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

Catalog Number UNKNOWN SNF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Death (1802); Thrombosis (2100)

Event Type  Death  

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 citation: 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, 6 patients died due to postoperative hemorrhage and 2 patients died due to pulmonary embolism, thrombosis of the inferior vena cava and both lower limbs following the introduction of the filter.One additional patient died shortly after filter insertion from the sequelae of pulmonary embolism that had occurred prior to filter insertion.

• Brand Name: SNF/SL
• 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 NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9517028
• MDR Text Key: 172618887
• Report Number: 2020394-2019-05856
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K970099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/24/2019

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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2019
• 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 Outcome(s): Death