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	10/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date: unknown; therefore, date is approximated.
Event or Problem Description
A greenfield filter was implanted on (b)(6) 2007.On an unknown date it was noted that perforation and tilt occurred.No further patient complications were reported.
Event or Problem Description
A greenfield filter was implanted on (b)(6) 2007.On an unknown date it was noted that perforation and tilt occurred.No further patient complications were reported.It was further reported that the greenfield filter deployed without difficulty.On (b)(6) 2017 the patient received a ct of the abdomen without contrast for an unspecified injury of the inferior vena cava.Findings revealed the filter was at the level of inferior endplate of 13 vertebral body.There is anterior tilting of the dome noted.The aorta demonstrates severe atherosclerotic calcification and ectasia.No abdominal aortic aneurysm.There is a retroaortic renal vein presents on the left.The pillars of the ivc filter just above the level of the lowest renal vein.No abnormal fragmentation or bending of the struts is suggested.The tip of the struts as seen in the axial views appear to be on extend ivc wall.However, it is unclear whether this represents volume averaging.There are no surrounding fluid or inflammation seen.No acute findings of the abdomen.Inferior vena cava and particular appears without distention or anatomic abnormalities.Ivc filter in place, with the dome of the filter tilting anteriorly approximately 2 mm from the anterior luminal wall.The tip of the struts appears to extend beyond the ivc wall.Unclear whether this is volume averaging or represents penetration.No surrounding fluid or inflammation is seen.No thickening of the ivc wall is visualized.

• 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: 9828534
• Report Number: 2134265-2020-03216
• Device Sequence Number: 19590388
• Product Code: DTK
• UDI-Device Identifier: 08714729070276
• UDI-Public: 08714729070276
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

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: 02/28/2010
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0009532717
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 05/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR