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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Perforation (2001)
Event Date 12/01/2019
Event Type  Injury  
Manufacturer Narrative
Event date is approximated since unknown.
 
Event Description
It was reported that the patient has chronic pain.On (b)(6) 2001, the patient was implanted with a greenfield vena cava filter (gvcf).At an unknown time, the patient reports he suffered debilitating injuries from the vena cava filter including chronic pain.
 
Manufacturer Narrative
Event date is approximated since unknown.
 
Event Description
It was reported that the patient has chronic pain.On (b)(6) 2001, the patient was implanted with a greenfield vena cava filter (gvcf).At an unknown time, the patient reports he suffered debilitating injuries from the vena cava filter including chronic pain.It was further reported that the patient had a ct of their abdomen on (b)(6) 2017.The imaging showed that an ivc filter is noted.The superior tip is approximately 2cm below the right renal vein with the tip touching the medial wall of the ivc.The angulation is unchanged with no increased evidence of tilt.The struts perforate the wall of the ivc.The strut at 8:00 contains a 1.5mm fat plane between it and the ivc.The strut at 6:00 abuts the lumbar disc space and is approximately 3mm posterior to the wall of the ivc.The remaining struts abut the wall with no fat plane.There is no obvious perforation of adjacent structures.The ivc is normal in caliber.
 
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Brand Name
GREENFIELD
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9498933
MDR Text Key173335926
Report Number2134265-2019-16019
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 05/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/09/2019
Initial Date FDA Received12/19/2019
Supplement Dates Manufacturer Received04/28/2020
Supplement Dates FDA Received05/14/2020
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age66 YR
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