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	08/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2014 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan revealed the filter was position below the level of the renal veins.There is tilting proximally to right by 12 degrees.Distal anchoring struts do not extend beyond vessel wall.Second ivc filter lies outside vascular system in right retroperitoneum along postero-medial aspect of root psoas muscle.Anchoring struts may be within right common iliac vein.
Event or Problem Description
On (b)(6) 2014 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computated tomography (ct) scan revealed the filter was position below the level of the renal veins.There is tilting proximally to right by 12 degrees.Distal anchoring struts do not extend beyond vessel wall.Second ivc filter lies outside vascular system in right retroperitoneum along postero-medial aspect of root psoas muscle.Anchoring struts may be within right common iliac 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: 9948494
• Report Number: 2134265-2020-04929
• Device Sequence Number: 16968150
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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: 07/31/2016
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0016317044
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 08/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR