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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 43335
Device Problems Break (1069); Positioning Problem (3009); Migration (4003)
Patient Problem Perforation (2001)
Event Date 08/29/2017
Event Type  Injury  
Event Description
A greenfield filter was implanted on (b)(6) 2006.On (b)(6) 2017, it was noted there was a perforation.The filter was noted to be fractured, tilted and migration had occurred.No further patient complications were reported.
 
Event Description
A greenfield filter was implanted on (b)(6) 2006.On (b)(6) 2017, it was noted there was a perforation.The filter was noted to be fractured, tilted and migration had occurred.No further patient complications were reported.It was further reported the patient has a medical history of blood clots with pulmonary embolism (1990s; was on warfarin anticoagulation until 2006; has greenfield filter).On (b)(6) 2015 a ct of the abdomen revealed the ivc filter was within the infrarenal ivc and was unchanged in appearance.The patient was admitted on (b)(6) 2015 and a ct of the pelvis showed presumed osteophyte between the anterior vertebral body and area adjacent to the ivc filter.It was unclear how this was related, especially since the filter was placed in 2006 and bony growth was likely to have occurred prior to onset of pain symptoms.Patient was deferred to vascular surgery/radiology on significance of this finding and whether this warranted removal of the filter.An x-ray of the lumbar spine performed on (b)(6) 2016 revealed a fracture of the caudal portion of one of the filters legs which extended into the anterior l2-l3 disc.A ct of the abdomen dated (b)(6) 2017 demonstrates the filter was abnormally tilted with penetration of the legs of the filter into the pericaval/mesenteric fat, a mesenteric vein, and into the anterior periosteum of a lumbar vertebra.A cta of the abdomen and pelvis with contrast was performed on 01mar2019 revealed the ivc filter was fractured with perforated struts.One of the posterior most struts fractures at the level of superior endplate of l3 vertebral body.Removal of the ivc filter at this time was not thought to be beneficial.
 
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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
MDR Report Key9828542
MDR Text Key183371930
Report Number2134265-2020-03207
Device Sequence Number1
Product Code DTK
UDI-Device Identifier08714729124993
UDI-Public08714729124993
Combination Product (y/n)N
PMA/PMN Number
K955396
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/30/2008
Device Model Number43335
Device Catalogue Number43335
Device Lot Number0008449607
Was Device Available for Evaluation? No
Date Manufacturer Received04/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
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