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	06/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2003 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan revealed the filter tilted 10 degrees to the right and 26 degrees anteriorly.The apex of the filter was touching the anterior wall.The tines perforated up to 2mm and one tine slightly contacted the outer surface of the adjacent aorta.
Event or Problem Description
On (b)(6)2003 the patient underwent placement of a greenfield vena cava filter.On (b)(6)2019 a computed tomography (ct) scan revealed the filter tilted 10 degrees to the right and 26 degrees anteriorly.The apex of the filter was touching the anterior wall.The tines perforated up to 2mm and one tine slightly contacted the outer surface of the adjacent aorta.

• 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: 9943542
• Report Number: 2134265-2020-04613
• Device Sequence Number: 13619466
• 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: 2003
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2020

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: 08/01/2006
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0005805236
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 08/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR