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	11/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2007 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2018 a computed tomography (ct) scan revealed the apex of the filter was 16-17 degrees to the left and was touching the left side of the inferior vena cava (ivc) wall.All 6 struts perforate the ivc wall and extend 1-3 mm into surrounding fat.A mesenteric perforation was noted.No further information is available at this time.
Additional Manufacturer Narrative
Field change: a1.
Event or Problem Description
On (b)(6)2007 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2018 a computed tomography (ct) scan revealed the apex of the filter was 16-17 degrees to the left and was touching the left side of the inferior vena cava (ivc) wall.All 6 struts perforate the ivc wall and extend 1-3 mm into surrounding fat.A mesenteric perforation was noted.No further information is available at this time.

• 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: 9955868
• Report Number: 2134265-2020-05034
• Device Sequence Number: 19481995
• 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): 07/31/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2009
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0009312407
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 07/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR