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	01/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2004 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2020 a computed tomography (ct) scan of the abdomen/pelvis revealed the filter sitting crooked in the inferior vena cava with the apex resting against the right lateral wall.The struts of the filter perforated the lumen of the inferior vena cava.There was no involvement of the adjacent aorta or duodenum.
Event or Problem Description
On (b)(6) 2004 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2020 a computed tomography (ct) scan of the abdomen/pelvis revealed the filter sitting crooked in the inferior vena cava with the apex resting against the right lateral wall.The struts of the filter perforated the lumen of the inferior vena cava.There was no involvement of the adjacent aorta or duodenum.
Additional Manufacturer Narrative
Field change: a1,a2,a3.

• 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: 9939022
• Report Number: 2134265-2020-04682
• Device Sequence Number: 644453
• 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: 2004
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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: 02/01/2006
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0005403626
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 07/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR