MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENFIELD; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	43335
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown; therefore, date is approximated.
Event or Problem Description
A greenfield filter was implanted on (b)(6) 2011.On an unknown date it was noted there was a perforation.The filter was noted to be tilted.No further patient complications were reported.
Event or Problem Description
A greenfield filter was implanted on (b)(6) 2011.On an unknown date it was noted there was a perforation.The filter was noted to be tilted.No further patient complications were reported.It was further reported that the greenfield vena cava filter was placed as precaution as the patient had positive left posterior tibial vein thrombosis.The procedure was completed without complication.The patient was discharged home after arrangements for outpatient iv antibiotics were made.On (b)(6) 2017, a ct scan of the abdomen was performed.The examination findings revealed the ivc filter insertion with 10 degrees right lateral tilt of the filter.The filter tip touches the right lateral caval wall just below the right renal vein origin.Three ivc struts noted at 1 o'clock, 4 o'clock and 5 o'clock extend 0.3 cm through the caval wall.There is no para-aortic or paracaval adenopathy.The ivc filter was at a 10 degree right lateral tilt and 3mm perforation of three filter struts through the left lateral caval wall.

• Brand Name: GREENFIELD
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9837358
• Report Number: 2134265-2020-03369
• Device Sequence Number: 1299721
• Product Code: DTK
• UDI-Device Identifier: 08714729070276
• UDI-Public: 08714729070276
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0013868236
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR