MAUDE Adverse Event Report: BOSTON SCIENTIFIC GREENFIELD FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2023

Event Type  Injury  

Event Description

Stainless steel over the wire greenfield filter found to be fractured, with one leg embolized to the right internal iliac artery and another in the right posterior abdomen.The remaining filter with 4 legs is in satisfactory (noting suprarenal) position.The embolized and migrated filter legs were removed percutaneously; the filter remains in place.

• Brand Name: GREENFIELD FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC; one boston scientific pl; natick MA 01760
• MDR Report Key: 17163585
• MDR Text Key: 317554310
• Report Number: MW5118470
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White