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

Model Number	43175
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Embolism (1829); Thrombosis (2100)
Date of Event	07/13/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
A greenfield filter was implanted on (b)(6) 2005.The patient underwent a greenfield filter placement.Filter number one was opened completely without any crossed legs but venogram showed ivc not completely protected.Patient then had filter number two placed, which was placed above the renal vein; it was open but also showed the ivc not completely protected.On (b)(6) 2012 ct imaging showed a thrombus was identified within one of the medium-sized right middle lobe arteries.Embolism is identified in the central left upper lobe branch with a tiny bit of thrombus within the descending left lower lobe pulmonary artery.The tip of the inferior filter is slightly angulated towards right.The patient was continued on anticoagulation therapy.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
• MDR Report Key: 10076476
• Report Number: 2134265-2020-06805
• Device Sequence Number: 14165263
• Product Code: DTK
• UDI-Device Identifier: 08714729114666
• UDI-Public: 08714729114666
• 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
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

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: 12/03/2007
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0007200115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR