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

Model Number	43335
Medical Device Problem Codes	Positioning Problem (3009); Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2009 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2018 a computed tomography (ct) scan of the abdomen revealed a slight tilting of the filter to the right and posteriorly but without the apex contacting the inferior vena cava (ivc) wall.There was a slight caudal migration of the filter with the apex 2.6cm caudal to the lowest renal vein.A filter strut had perforated the ivc wall up to 2mm but without adjacent organ penetration.The left lateral strut was in contact with the aorta wall.
Event or Problem Description
On (b)(6) 2009, the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2018, a computed tomography (ct) scan of the abdomen revealed a slight tilting of the filter to the right and posteriorly but without the apex contacting the inferior vena cava (ivc) wall.There was a slight caudal migration of the filter with the apex 2.6cm caudal to the lowest renal vein.A filter strut had perforated the ivc wall up to 2mm but without adjacent organ penetration.The left lateral strut was in contact with the aorta 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: 9940470
• Report Number: 2134265-2020-04693
• Device Sequence Number: 17068093
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2012
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0012614111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 07/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR