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

Model Number	43335
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date: unknown; therefore, date is approximated.
Event or Problem Description
A greenfield filter was implanted on (b)(6) 2008.On an unknown date it was noted that perforation had occurred.No further patient complications were reported.
Event or Problem Description
A greenfield filter was implanted on (b)(6) 2008.On an unknown date it was noted that perforation had occurred.No further patient complications were reported.It was further reported that on (b)(6) 2017 the patient was seen to assess the ivc filter position.The patient received a ct of the abdomen without contrast.Findings revealed that the ivc filter tip appears positioned at the posterior wall.The tip of the filter appears embedded at the posterior wall which will likely make retrieval more difficult.The legs of the filter appear to extend just beyond the wall nc 2 mm into the retroperitoneal fat without extension into any of the surrounding structures.No significant filter tilt identified.The filter appears to be positioned such that it will function appropriately.Filter is in appropriate position immediately below the renal veins.No inferior vena cava stenosis.No filter fracture or bend strut.

• 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: 9829625
• Report Number: 2134265-2020-03234
• Device Sequence Number: 2830250
• 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: 2008
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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: 01/31/2011
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0011523411
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 05/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR