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	03/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2006 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) can of the abdomen revealed tilt and injury.There was a slight posterior tilt of approximately 2.5 degrees.The apex of the filter lied along the posterior inferior vena cava (ivc) wall.There were six intact struts seen.The anterior strut appeared to extend beyond the ivc wall by approximately 1mm anteriorly.The posterior strut questionable extended 1 to 2mm.There was apparent slight extension of the right strut beyond the ivc wall approximately 2 to 3mm lateral to right as well as adjacent strut extending approximately 2 to 3mm laterally to the right.There was apparent extension of postero lateral right strut measuring approximately 2mm laterally.No further patient complications were reported in relation to this event.
Event or Problem Description
On (b)(6) 2006 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) can of the abdomen revealed tilt and injury.There was a slight posterior tilt of approximately 2.5 degrees.The apex of the filter lied along the posterior inferior vena cava (ivc) wall.There were six intact struts seen.The anterior strut appeared to extend beyond the ivc wall by approximately 1mm anteriorly.The posterior strut questionable extended 1 to 2mm.There was apparent slight extension of the right strut beyond the ivc wall approximately 2 to 3mm lateral to right as well as adjacent strut extending approximately 2 to 3mm laterally to the right.There was apparent extension of postero lateral right strut measuring approximately 2mm laterally.No further patient complications were reported in relation to this event.

• 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: 9946841
• Report Number: 2134265-2020-04888
• Device Sequence Number: 678052
• Product Code: DTK
• UDI-Device Identifier: 08714729114659
• UDI-Public: 08714729114659
• 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: 2006
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: 06/30/2009
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0008896603
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 07/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR