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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); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 07/29/2019
Event Type  Injury  
Event Description

A greenfield filter was implanted on (b)(6) 2010. On (b)(6) 2019 the patient had a ct scan of their abdomen. The imaging showed that several of the struts were perforating the ivc. The stricts at the 12 o'clock position and 2 o'clock position appeared to penetrate into the duodenum. On (b)(6) 2019 a ct scan of the abdomen showed similar results as well as one strut that was adjacent to the abdominal aorta. On (b)(6) 2019 the patient had their greenfield filter removed. The duodenum was repaired during the surgery. Additionally one of the struts fractured and could not be located or removed from the patient.

 
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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 Key10376673
MDR Text Key202004958
Report Number2134265-2020-10682
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 Received07/09/2020
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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