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	04/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported vessel perforation occurred.On (b)(6) 2005, the patient was implanted with a greenfield filter utilizing an internal jugular vein approach.The patient was suffering from acute deep venous thrombosis with a free-floating proximal component.The device was deployed under real time fluoroscopic guidance.The struts were seen to deploy on axis as the device sat comfortably in the inferior vena cava (ivc) at about the l3 level.The implant procedure was successfully completed with no adverse patient consequences.On (b)(6) 2019, the patient underwent an abdominal ct scan without contrast.The greenfield filter was observed with the superior tip 2 cm inferior to the renal veins, with no significant tilt and no fractured struts identified.All 6 legs of the filter appeared to perforate the ivc by approximately 3 mm.There was no vascular or organ penetration of the perforated struts.No further patient complications were reported.

• Brand Name: GREENFIELD
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road cork; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15239294
• Report Number: 2124215-2022-30798
• Device Sequence Number: 14626130
• 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: 2005
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2022

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: 04/11/2008
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0007595496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male