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	06/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2005 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan of the abdomen revealed the apex of the filter sits adjacent to anterior wall of inferior vena cava (ivc) at the level of the right renal vein.Perforation of the wall manifests as a flat plane between ivc wall.The distal end of the filter component is present at posterior right lateral aspect.The remaining struts sit right at ivc wall without clear perforation.No further information is available at this time.
Event or Problem Description
On (b)(6) 2005 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan of the abdomen revealed the apex of the filter sits adjacent to anterior wall of inferior vena cava (ivc) at the level of the right renal vein.Perforation of the wall manifests as a flat plane between ivc wall.The distal end of the filter component is present at posterior right lateral aspect.The remaining struts sit right at ivc wall without clear perforation.No further information is available at this time.

• 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: 9955866
• Report Number: 2134265-2020-05036
• Device Sequence Number: 11412064
• 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): 07/27/2020

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: 06/29/2008
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0007826039
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 07/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR