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	06/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown, used the first date of the aware month.
Event or Problem Description
On (b)(6) 2007, the patient underwent placement of a greenfield vena cava filter.A computed tomography (ct) scan revealed that infrarenal inferior vena cava (ivc) filter noted was angled at approximately 10 degrees relative to the ivc.A few of the struts appeared to be bending.One of the struts was seen 2 mm from the right ivc wall.The apex of the filter abuts the anterior wall.
Event or Problem Description
On (b)(6) 2007, the patient underwent placement of a greenfield vena cava filter.A computed tomography (ct) scan revealed that infrarenal inferior vena cava (ivc) filter noted was angled at approximately 10 degrees relative to the ivc.A few of the struts appeared to be bending.One of the struts was seen 2 mm from the right ivc wall.The apex of the filter abuts the anterior wall.It was further reported that the patient had their ct scan 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: 9943616
• Report Number: 2134265-2020-04826
• Device Sequence Number: 18999285
• Product Code: DTK
• UDI-Device Identifier: 08714729124993
• UDI-Public: 08714729124993
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K955396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020

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: 12/31/2009
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0009344812
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 07/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR