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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 Break (1069)
Patient Problem Perforation (2001)
Event Date 10/24/2017
Event Type  Injury  
Event Description

A greenfield filter was implanted on (b)(6) 2004. On (b)(6) 2017 the patient had a ct scan of their abdomen. The imaging showed that an azygous vein was patent and the ivc fills above the occluded filter via the azygous system. In addition, 2 tines of the filter were fractured. On (b)(6) 2019 the patient had a ct scan of their abdomen and imaging showed that the top of the filter is seen at the suprarenal ivc with the filter coursing across the bilateral renal veins. The spires extend beyond the lumen of the ivc which is small proximal to the filter.

 
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Brand NameGREENFIELD
Type of DeviceFILTER, 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 Key10376069
MDR Text Key201940002
Report Number2134265-2020-10659
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
Type of Report Initial
Report Date 08/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/06/2020 Patient Sequence Number: 1
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