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	06/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2009, the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, msr2_prime , computed tomography (ct) scan revealed there was a 2.7 degree tilt to the left.There was an 8.4 degree anterior tilt.No strut fracture was noted.All 6 of the struts extend beyond the wall of the ivc.The left lateral strut at 3:00 position does appear to extend into the aorta.
Event or Problem Description
On (b)(6) 2009, the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, msr2_prime , computed tomography (ct) scan revealed there was a 2.7 degree tilt to the left.There was an 8.4 degree anterior tilt.No strut fracture was noted.All 6 of the struts extend beyond the wall of the ivc.The left lateral strut at 3:00 position does appear to extend into the aorta.

• 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: 9943856
• Report Number: 2134265-2020-04824
• Device Sequence Number: 13619639
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2020

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: 05/31/2012
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0012706419
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 08/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR