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	06/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2012 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan revealed the filter was tilted greater than 15 degrees.The tip of the filter was projecting the lateral right margin of the ivc.All struts penetrate the margin of the ivc and abut the posterior wall of the small bowel.A strut is in close proximity to the wall of the aorta.The strut abuts the prevertebral soft tissues and cortex of the l4 vertebral body.Another strut penetrates the psoas muscle, and another strut abuts a small vein.
Event or Problem Description
On (b)(6) 2012 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan revealed the filter was tilted greater than 15 degrees.The tip of the filter was projecting the lateral right margin of the ivc.All struts penetrate the margin of the ivc and abut the posterior wall of the small bowel.A strut is in close proximity to the wall of the aorta.The strut abuts the prevertebral soft tissues and cortex of the l4 vertebral body.Another strut penetrates the psoas muscle, and another strut abuts a small vein.

• 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: 9938754
• Report Number: 2134265-2020-04731
• Device Sequence Number: 643850
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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: 05/31/2014
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0014420897
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR