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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENFIELD; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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BOSTON SCIENTIFIC CORPORATION GREENFIELD; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Device Problem Positioning Problem (3009)
Patient Problem Perforation (2001)
Event Date 02/26/2019
Event Type  Injury  
Event Description
On (b)(6) 2003, the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan of the abdomen revealed that the filter was mildly tilted anteriorly with the superior tip of the filter anteriorly positioned in the lumen.It also noted that the ivc filter tip was approximately 3 cm abovel level of right renal vein and 1.6cm above left renal vein.There was one strut appearing outside ivc lumen towards midline touching adjacent aorta and perforated 2.8mm.Three other struts were also outside lumen anteriorly, posteriorly and laterally.All perforate 1mm.No further patient complications were reported.
 
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Brand Name
GREENFIELD
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10464735
MDR Text Key204694212
Report Number2134265-2020-11856
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other
Type of Report Initial
Report Date 08/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received07/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
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