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

Model Number	43175
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a perforation occurred.At an unknown time, the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan showed that an infrarenal inferior vena cava (ivc) filter is present.There was some extra venous extension of the right lateral 3 legs into the perivascular fat.There was no evidence of intraosseous or aortic penetration.The anterior most leg abuts the gondal vein.There was no tilt, stenosis, fracture or migration noted.
Event or Problem Description
It was reported a perforation occurred.At an unknown time, the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan showed that an infrarenal inferior vena cava (ivc) filter is present.There was some extra venous extension of the right lateral 3 legs into the perivascular fat.There was no evidence of intraosseous or aortic penetration.The anterior most leg abuts the gondal vein.There was no tilt, stenosis, fracture or migration noted.It was further reported that the patient underwent placement of their ivc filter on (b)(6) 2009.

• 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: 9943619
• Report Number: 2134265-2020-04827
• Device Sequence Number: 666089
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2011
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0012080259
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 07/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR