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	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2013, the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan of the abdomen and an injury revealed that the device had 7 degrees anterior tilt.Tilt of filter abuts anterior wall of ivc, but there is no definitive perforation of inferior vena cava (ivc) wall by any filter struts.No further patient complications were reported.
Event or Problem Description
On (b)(6) 2013, the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan of the abdomen and an injury revealed that the device had 7 degrees anterior tilt.Tilt of filter abuts anterior wall of ivc, but there is no definitive perforation of inferior vena cava (ivc) wall by any filter struts.No further patient complications were reported.

• 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: 9943061
• Report Number: 2134265-2020-04706
• Device Sequence Number: 13619464
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0015408424
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 08/04/2020
• Patient Sequence Number: 1
• Patient Age: 62 YR