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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
Model Number 43175
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Perforation (2001)
Date of Event 08/15/2019
Type of Reportable Event Serious Injury
Event or Problem Description
On (b)(6) 2006 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan of the abdomen revealed the filter in the inferior vena cava (ivc) was present.The dome was located just superior to the junction of the renal veins with ivc.The filter struts diffusely bulge the ivc walls with posterior strut protruding 4mm posterior to ivc wall, abutting l2 vertebral body.All remaining struts show penetration.No further information is available at this time.
 
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Brand Name
GREENFIELD
Common Device Name
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9955840
Report Number2134265-2020-05035
Device Sequence Number2438295
Product Code DTK
UDI-Device Identifier08714729114666
UDI-Public08714729114666
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K901659
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/13/2020
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? No
Operator of Device Health Professional
Device Expiration Date05/24/2008
Device Model Number43175
Device Catalogue Number43175
Device Lot Number0007727168
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/24/2020
Initial Report FDA Received Date04/13/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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