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	09/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, the patient underwent placement of a greenfield inferior vena cava (ivc) filter.On (b)(6) 2018, a computed tomography (ct) scan revealed abnormal tilting of the filter of over 20 degrees.It was also noted that multiple struts were perforating the ivc wall up to 4mm and the ivc struts extended and abutted the third portion of the duodenum and aortic wall.There was no evidence of migration, fracture or stenosis.
Event or Problem Description
On (b)(6) 2016, the patient underwent placement of a greenfield inferior vena cava (ivc) filter.On (b)(6) 2018, a computed tomography (ct) scan revealed abnormal tilting of the filter of over 20 degrees.It was also noted that multiple struts were perforating the ivc wall up to 4mm and the ivc struts extended and abutted the third portion of the duodenum and aortic wall.There was no evidence of migration, fracture or stenosis.

• 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: 9946792
• Report Number: 2134265-2020-04880
• Device Sequence Number: 678050
• Product Code: DTK
• UDI-Device Identifier: 08714729124993
• UDI-Public: 08714729124993
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K955396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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: 03/31/2018
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0017852858
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR