MAUDE Adverse Event Report: MEDICAL DEVICES INC. OPTION ELITE IVC FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/24/2022

Event Type  Injury  

Event Description

Option elite ivc filter found to be multiply fractured.Removed filter and fractured fragment retained locally with forceps.Fda safety report id (b)(4).

• Brand Name: OPTION ELITE IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): MEDICAL DEVICES INC.
• MDR Report Key: 15310871
• MDR Text Key: 298935500
• Report Number: MW5111740
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White