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

Model Number	43175
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2005, the patient underwent placement of a greenfield vena cava filter.On an unknown date, computed tomography (ct) scan revealed mesenteric perforation.There was no sign of filter tilt, migration, fracture/bending, stenosis.The depth of penetration/perforation was not reported.
Event or Problem Description
On (b)(6) 2005, the patient underwent placement of a greenfield vena cava filter.On an unknown date, computed tomography (ct) scan revealed mesenteric perforation.There was no sign of filter tilt, migration, fracture/bending, stenosis.The depth of penetration/perforation was not reported.It was further reported that on (b)(6) 2019 the patient had the ct of their abdomen.The imaging showed that there is a retroaortic left renal vein.The tip of the ivc filter is placed at the origin of the left renal vein.The ivc filter is directed straight along the course of the ivc.The tip of the filter is adjacent but does not appear to touch the left lateral ivc wall.The distal progs of the ivc filter extends slightly beyond the ivc wall.Subtle fatty tissue planes are noted along the anterior struts.The ivc filter does not involve surroundings structures.There is no fracture of the filter struts.The ivc filter terminates before the bifurcation into the common iliac veins.

• 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: 9943903
• Report Number: 2134265-2020-04838
• Device Sequence Number: 574235
• 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: 2005
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: 09/28/2007
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0006991489
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 07/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR