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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 Problem Positioning Failure (1158)
Patient Problems Pain (1994); Perforation of Vessels (2135)
Event Date 06/21/2017
Event Type  Injury  
Event Description

It was reported the device did not fully deploy and later a perforation occurred. On (b)(6) 2004 the patient under implantation of a greenfield vena cava filter. This filter did not fully deploy, so a second filter was surgically implanted. On (b)(6) 2017 the patient received a ct scan. These images showed that: the tip of the superior filter implanted in the patient had tilted into their right renal vein; that many of the filter struts had perforated beyond the inferior vena cava wall, one leg abuts the aortic wall and that two legs abut the wall of the duodenum. On (b)(6) 2017, the patient received another ct scan which revealed that the superior filter had titled and was angulated approximately 30-40 degrees, one of the struts of the superior filter abuts the aortic intima, another strut abuts the posterior duodenum, another superior filter abuts the anterior aspect of the l3 vertebral body, with subjacent bony remodeling; the inferior filter was within 10 degrees of parallel to the superior filter and the struts of both filters extended beyond the ivc wall. On (b)(6) 2017, the patient had surgery to remove both filters as they were symptomatic with pain. The surgeon noted the more superior filter had significant tilt with the hook near the right renal vein embedded in a fibrin cap and that several struts extended beyond the ivc wall.

 
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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
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8634034
MDR Text Key145860322
Report Number2134265-2019-05446
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
Reporter Occupation
Type of Report Initial
Report Date 05/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number43175
Device Catalogue Number43175
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2019
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: 05/22/2019 Patient Sequence Number: 1
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