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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 Problems Break (1069); Positioning Problem (3009); Migration (4003)
Patient Problem Perforation (2001)
Event Date 03/12/2015
Event Type  Injury  
Event Description
A greenfield filter was implanted on (b)(6) 2003.On (b)(6) 2015 it was noted there was 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) 2003.On (b)(6) 2015 it was noted there was perforation.The filter was noted to be fractured, tilted and migration had occurred.No further patient complications were reported.It was further reported that during the filter implant procedure it was documented that the filter was deployed below the level of the renal veins at the l2 level.No complications were encountered.On (b)(6) 2017, the patient received a ct exam of the abdomen without contrast.Findings revealed that the ivc filter with the proximal tip located approximately 1cm below the renal veins and is angulated to the right and anterior to by approximately 10 15 degrees.The ivc is flattened.This makes evaluation somewhat difficult.The proximal tip of the filter appears to abut and likely extends beyond the wall of the anterior ivc.There are 6 struts.The most posterior strut is fractured with the distal 1.4cm fractured strut fragment partially buried within the l3 inferior vertebral body.The remaining 5 struts all extend beyond the ivc wall without definite involvement of adjacent structures.
 
Event Description
A greenfield filter was implanted on (b)(6) 2003.On (b)(6) 2015 it was noted there was perforation.The filter was noted to be fractured, tilted and migration had occurred.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
MDR Report Key9818639
MDR Text Key182974973
Report Number2134265-2020-02934
Device Sequence Number1
Product Code DTK
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,Followup
Report Date 05/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received05/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age30 YR
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