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	02/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2002 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 , a computed tomography (ct) scan revealed that the filter had tilted laterally to the right and there was anterior tilting.Apex of filter does contact antero-lateral wall of inferior vena cava (ivc) on right.Apex is located approximately 20mm distal to left renal vein origin.All 6 struts do protrude beyond wall/lumen of ivc.3 anterior struts extend beyond wall of ivc approximately by 6mm.Anterior strut partially extended into small vein and remainder of struts do not appear to definitely involve adjacent organs.
Event or Problem Description
On (b)(6) 2002 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 , a computated tomography (ct) scan revealed that the filter had tilted laterally to the right and there was anterior tilting.Apex of filter does contact antero-lateral wall of inferior vena cava (ivc) on right.Apex is located approximately 20mm distal to left renal vein origin.All 6 struts do protrude beyond wall/lumen of ivc.3 anterior struts extend beyond wall of ivc approximately by 6mm.Anterior strut partially extended into small vein and remainder of struts do not appear to definitely involve adjacent organs.It was further reported that the 3 most posteriorly positioned struts extend beyond the lumen of the ivc by approximately 4 mm each.The apex of the ivc filter does not appear to protrude beyond the wall of the ivc.No abnormal fluid collection is seen about the ivc.

• 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: 9945883
• Report Number: 2134265-2020-04856
• Device Sequence Number: 766427
• 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: 2002
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2005
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0004899132
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 07/23/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR