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

Model Number	43175
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/30/2019
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) 2019 a computed tomography (ct) scan of the abdomen/pelvis-infrarenal revealed there is slight penetration of the caval wall by all of the filter struts and considered to be within normal limits.There was no surrounding inflammatory change.On (b)(6) 2019 a ct of the abdomen revealed the filter had a 6 degree tilt and there was aortic perforation.
Event or Problem Description
On (b)(6) 2009 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan of the abdomen/pelvis-infrarenal revealed there is slight penetration of the caval wall by all of the filter struts and considered to be within normal limits.There was no surrounding inflammatory change.On (b)(6) 2019 a ct of the abdomen revealed the filter had a 6 degree tilt and there was aortic perforation.

• 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: 9937916
• Report Number: 2134265-2020-04615
• Device Sequence Number: 16307215
• Product Code: DTK
• UDI-Device Identifier: 08714729114659
• UDI-Public: 08714729114659
• 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
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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: 01/31/2012
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0012401910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 08/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR