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	05/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2012, 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 located below the level of the renal veins approximately about 1.8cm.The apex of the ivc filter was touching the anterior wall of the ivc.There appeared to be mild anterior tilt at the apex which measured up to 10 degrees.The tips of all limbs of the ivc filter protruded beyond the wall of the ivc up to 2-3mm.
Event or Problem Description
On (b)(6) 2012, 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 located below the level of the renal veins approximately about 1.8cm.The apex of the ivc filter was touching the anterior wall of the ivc.There appeared to be mild anterior tilt at the apex which measured up to 10 degrees.The tips of all limbs of the ivc filter protruded beyond the wall of the ivc up to 2-3mm.

• 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: 9947462
• Report Number: 2134265-2020-04905
• Device Sequence Number: 3258297
• 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: 2012
• 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: 05/31/2015
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0015343883
• 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