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

Model Number	43335
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown; therefore, date is approximated.
Event or Problem Description
A greenfield filter was implanted on (b)(6) 2005.On an unknown date it was noted that the filter was tilted.No patient complications were reported.
Event or Problem Description
A greenfield filter was implanted on (b)(6) 2005.On an unknown date it was noted that the filter was tilted.No patient complications were reported.It was further reported that the patient had a ct of their abdomen on (b)(6) 2017.The imaging showed that there is an ivc filter in place.The ivc filter is tilted with the apex of the filter touching the medial wall of the ivc.The ivc angulates toward the right at the level of the ivc filter due to the lumber scoliosis.The ivc filter tip is 2.2cm below the left renal vein which on the coronal imaging appears slightly lower than the right renal vein.The struts of the ivc filter appear intact without a significant degree of abnormal bend identified.No perforation of the ivc filter through the wall of the ivc is identified.There is no stenosis of 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: 9825888
• Report Number: 2134265-2020-03149
• Device Sequence Number: 3068320
• Product Code: DTK
• UDI-Device Identifier: 08714729070276
• UDI-Public: 08714729070276
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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: 10/04/2008
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0008080462
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR