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

Model Number	43175
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2007, the patient underwent placement of a greenfield inferior vena cava (ivc) filter.On (b)(6) 2019, a computed tomography (ct) scan revealed tilt and perforation.The ivc filter was in the infrarenal segment, the apex of the filter was below the renal veins.There was no significant tilt in the anterioposterior (ap) dimension.The superior apex of the filter contacted the anterior wall of the ivc.With regard to perforation, distal struts perforation posteriorly toward the left on axial image, abuts the posterior wall of the aorta externally.Adjacent to this there is contact of one of the struts with an anterior intravertebral osteophytes.Also toward the right axial image, one of the struts perforate the ivc and contact the adjacent small bowel loop.Anterior struts show perforation into the adjacent fat.There is no significant broken or bent filter component and no evidence of ivc stenosis.
Event or Problem Description
On (b)(6) 2007, the patient underwent placement of a greenfield inferior vena cava (ivc) filter.On (b)(6) 2019, a computed tomography (ct) scan revealed tilt and perforation.The ivc filter was in the infrarenal segment, the apex of the filter was below the renal veins.There was no significant tilt in the anteriorposterior (ap) dimension.The superior apex of the filter contacted the anterior wall of the ivc.With regard to perforation, distal struts perforation posteriorly toward the left on axial image, abuts the posterior wall of the aorta externally.Adjacent to this there is contact of one of the struts with an anterior intravertebral osteophytes.Also toward the right axial image, one of the struts perforate the ivc and contact the adjacent small bowel loop.Anterior struts show perforation into the adjacent fat.There is no significant broken or bent filter component and no evidence of ivc stenosis.

• 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: 9947472
• Report Number: 2134265-2020-04896
• Device Sequence Number: 3295927
• Product Code: DTK
• UDI-Device Identifier: 08714729114659
• UDI-Public: 08714729114659
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K901659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: 08/31/2010
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0011114015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR