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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK TITANIUM GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR

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BOSTON SCIENTIFIC - CORK TITANIUM GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number UNK141
Device Problem Occlusion Within Device (1423)
Patient Problems Fever (1858); Pain (1994); Thrombus (2101)
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: the device was not returned for analysis. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).
 
Event Description
It was reported that the patient experienced complications and the filter was occluded. In (b)(6) 2005, the patient was admitted to the hospital with a diagnosis of right lower extremity deep vein thrombosis (dvt). Two days later a clot extraction was performed on her right leg and a greenfield filter was implanted in her left inferior vena cava. The patient's hospital course was complicated by fever of unknown etiology. The patient remained at the hospital for a total of 10 days before being transferred to another facility where she underwent an angiojet thrombectomy procedure. The patient was discharged from that facility 11 days later. In (b)(6) 2005, approximately 2 weeks post discharge, the patient was taken to the emergency room complaining of left thigh and lower abdomen pain. She was admitted to the hospital the next day due to extensive clots in the right lower extremity and acute dvt of the left lower extremity. In (b)(6) 2010, the patient was seen for possible occlusion of the greenfield filter. The patient returned approximately 2 weeks later for the same reason. In (b)(6) 2015 a ct scan revealed the greenfield filter was occluded. The patient must continue to be on blood thinners the rest of her life.
 
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Brand NameTITANIUM GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5702766
MDR Text Key46673355
Report Number2134265-2016-04733
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K901659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 05/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK141
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2016
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? No
Type of Device Usage Initial

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