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

Model Number	43175
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001)
Date of Event	08/26/2019
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 superior tip of inferior vena cava (ivc) filter is located in ivc portion which is within liver.The superior tip of the filter is 1cm inferior to the right hemi-diaphragm.The filter was not fractured.All struts of have migrated outside of ivc.
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 superior tip of inferior vena cava (ivc) filter is located in ivc portion which is within liver.The superior tip of the filter is 1cm inferior to the right hemi-diaphragm.The filter was not fractured.All struts of have migrated outside of ivc.
Additional Manufacturer Narrative
B5: describe event or problem: additional information.H6: patient codes: added pain code.H6: impact codes: added code.
Event or Problem Description
On 29 april 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 superior tip of inferior vena cava (ivc) filter is located in ivc portion which is within liver.The superior tip of the filter is 1cm inferior to the right hemi-diaphragm.The filter was not fractured.All struts of have migrated outside of ivc.It was further reported that the patient has experienced pain.

• Brand Name: GREENFIELD
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 9943538
• Report Number: 2134265-2020-04631
• Device Sequence Number: 665466
• 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: 2005
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2022

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: 02/22/2008
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0007434690
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/16/2020; 08/24/2022
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 07/23/2020; 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Unknown