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

Model Number	43175
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2009, the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2020, a scan revealed that the implanted greenfield filter had migrated and is slightly high.Two prongs had perforated the inferior vena cava (ivc) and one prong had perforated the right lateral wall of the aorta.

• Brand Name: GREENFIELD
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11747257
• Report Number: 2134265-2021-05338
• Device Sequence Number: 4318937
• Product Code: DTK
• UDI-Device Identifier: 08714729114666
• UDI-Public: 08714729114666
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K901659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2012
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0012614118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/29/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other