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

Model Number	43335
Medical Device Problem Codes	Positioning Problem (3009); Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2001 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan revealed that the ivc filter tip was located abnormally low below the lowest renal vein, beginning 3cm inferior to left renal vein.It was abnormally tilted by 32 degrees to the left and 10 degrees posteriorly.There was a perforation of all struts without fracture.Numerous struts perforated up to 14mm beyond the lumen.No further patient complications were reported in relation to this event.
Event or Problem Description
On (b)(6) 2001, the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan revealed that the ivc filter tip was located abnormally low below the lowest renal vein, beginning 3cm inferior to left renal vein.It was abnormally tilted by 32 degrees to the left and 10 degrees posteriorly.There was a perforation of all struts without fracture.Numerous struts perforated up to 14mm beyond the lumen.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: 9946850
• Report Number: 2134265-2020-04885
• Device Sequence Number: 16313163
• 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: 2001
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: 12/01/2003
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0003656815
• 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: 07/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR