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	Perforation (2001)
Date of Event	10/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device tilting and a patient perforation occurred.In (b)(6) 2012, a greenfield filter was implanted in a patient in (b)(6) 2019, a computed tomography (ct) revealed the apex of filter lied within 5mm of the confluence of the right renal vein.There was posterior tilt of apex.There was also a borderline strut perforation along 2 posterior struts and medial strut.The medial strut contacts surface of aorta.
Event or Problem Description
It was reported that device tilting and a patient perforation occurred.In (b)(6) 2012, a greenfield filter was implanted in a patient in (b)(6) 2019, a computed tomography (ct) revealed the apex of filter lied within 5mm of the confluence of the right renal vein.There was posterior tilt of apex.There was also a borderline strut perforation along 2 posterior struts and medial strut.The medial strut contacts surface of 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: 9938837
• Report Number: 2134265-2020-04677
• Device Sequence Number: 16304649
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

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: Lay User/Patient
• Device Expiration Date: 01/31/2013
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0013248487
• 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: 04/08/2020
• Supplement Report FDA Received Date: 08/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR