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

Model Number	43335
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of the event was not given, so the aware date was used.
Event or Problem Description
It was reported that a perforation occurred.Computed tomography scan of the abdomen revealed positive for perforation.The filter tines extended beyond the mural margins of inferior vena cava.
Additional Manufacturer Narrative
Field change.
Event or Problem Description
It was reported that a perforation occurred.Computed tomography scan of the abdomen revealed positive for perforation.The filter tines extended beyond the mural margins of inferior vena cava.It was further reported that the patient underwent greenfield filter placement on (b)(6) 2007.The patient had a ct scan of their abdomen on (b)(6) 2018.

• 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: 9934891
• Report Number: 2134265-2020-04626
• Device Sequence Number: 11387144
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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: 06/30/2009
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0008881971
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 07/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR