MAUDE Adverse Event Report: IVC FILTER

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762)

Event Date 05/30/2016

Event Type  Death  

Event Description

Sudden death of unclear etiology.Medical examiner contacted, no autopsy performed.Pet.Was known to have an ivc filter (unknown manufacturer) which had broken and one limb of the filter had migrated to the left lung base (prior to this hospitalization).Pt.Had discontinued anticoagulation (xarelto) due to gi bleed.Cause of death attributed to cardiac event, or pulmonary embolus.Dates of use: 5 years.Diagnosis or reason for use: factor v leiden deficiency (clotting disorder).

• Brand Name: IVC FILTER
• Type of Device: IVC FILTER
• MDR Report Key: 5905419
• MDR Text Key: 53435671
• Report Number: MW5064339
• Device Sequence Number: 1
• Product Code: DTK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 49 YR
• Patient Weight: 80