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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 Positioning Failure (1158); Positioning Problem (3009); Migration (4003)
Patient Problems Perforation of Vessels (2135); No Consequences Or Impact To Patient (2199)
Event Date 05/31/2019
Event Type  Injury  
Event Description

It was reported that a perforation occurred and the filter migrated. A greenfield filter was planned to be implanted in the patient. The procedure started with a femoral access. Once the implant site was determined, the femoral filter was prepared, but it did not deploy correctly. The implant site puncture resulted in a hematoma. This hematoma required no intervention. The medical staff checked for stability and decided it was not a significant problem so the procedure was continued. Since there was no other femoral filters available, a new access site was made at the jugular level. Contrast was injected through the filter dilator. The physician observe some leak, but concluded that this was at the level of the previous femoral puncture. The implantation site for the jugular filter was then decided based on previous marks at the c arm screen. The filter was deployed according to the procedure, but the legs seemed to be not fully opened. Imaging showed that the device only opened about 20%. The medical staff seemed to think that the filter was deployed outside the vascular system at the ilium bone level, instead of the vena cava where the physician was trying to deploy it. The filter is believed to be outside the venous system, probably in a muscle. It is also believed that the system perforated the vein at some level, however no vital signs were altered, so the procedure continued. There was no more contrast so no control image was made. The procedure then ended and the patient was reported stable. Since the patients previous disease was a column lesion, there were other medical interventions made during the patients stay at the hospital. In addition, their movement was severely limited by the previous comorbidities, there was no assessment of any filter related injury. It has not been planned to remove the filter. The patient remains hospitalized and in need of a spine surgery.

 
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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 (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road
cork
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8798630
MDR Text Key151309503
Report Number2134265-2019-08100
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeMX
PMA/PMN NumberK964284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number43335
Device Catalogue Number43335
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2019
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: 07/17/2019 Patient Sequence Number: 1
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