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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 43175
Device Problems Positioning Failure (1158); Positioning Problem (3009)
Patient Problems Perforation (2001); No Code Available (3191)
Event Date 06/07/2007
Event Type  Injury  
Event Description

A greenfield filter was implanted on (b)(6) 2007. On an unknown date it was noted that perforation and tilt occurred. It was further reported that a greenfield inferior vena cava (ivc) filter was implanted due to status post motor vehicle accident, failed prophylactic anticoagulation and developed a thrombus despite this. Lower extremity ultrasound showed incompressibility of vein in the left femoral system. She also required prolonged immobility. The ivc filter was implanted in an infrarenal position however, when it was deployed it was noted that there was not adequate opening of the legs of the filter and only one strut seemed to open in the proper manner. The other struts were located in the left lateral position and did not appear to be satisfactorily deployed. It was determined it was a nondeployment of the filter which was potential risk for embolization and the patient should undergo placement of a more proximal infrarenal ivc filter. An additional venogram confirmed mal-deployment of the first ivc filter, the struts were essentially crossed on themselves. A small catheter was then passed through the jugular sheath in an attempt to push the struts open. One strut did open, giving more security to the filter, however, the remaining four or five struts still maintained a fast locking situation. A second filter was then implanted, positioned in its infrarenal position such that the struts were in contact with the vena cava below the communication with the renal veins but above the previously deployed filter. An inferior vena cavogram was performed and showed struts of the second filter did not appear to be completely opened and in contact with the wall of the vena cava. To get better security of the two filters, angioplasty was performed on the proximal (second) filter in an attempt to open the struts. The struts then appeared to be in contact with the wall of the ivc. The following day a chest x-ray was done to check placement of the two filters. Two ivc filters were present, the upper one located at the level of t12-l1, the lower one located at the level of l3-l4.

 
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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 CORPORATION
model farm road
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10054155
MDR Text Key191708693
Report Number2134265-2020-06475
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK901659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 05/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2010
Device MODEL Number43175
Device Catalogue Number43175
Device LOT Number0009594928
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/26/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/13/2020 Patient Sequence Number: 1
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