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	02/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2008 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan revealed tilt of the filter and mesenteric perforation.There was minimal strut wall perforation along the tip of five (5) and six (6) of the caval legs, with no organ penetration.There was a 30 degree tilt to the right.No stenosis, fracture, or migration of the filter was noted.
Additional Manufacturer Narrative
Lot number updated to correct number.
Event or Problem Description
On (b)(6) 2008 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan revealed tilt of the filter and mesenteric peforation.There was minimal strut wall perforation along the tip of five (5) and six (6) of the caval legs, with no organ penetration.There was a 30 degree tilt to the right.No stenosis, fracture, or migration of the filter was noted.

• 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: 9943899
• Report Number: 2134265-2020-04815
• Device Sequence Number: 666094
• 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: 2008
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• 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: 10/31/2010
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0011293156
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 08/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR