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

Model Number 43175

Device Problem Positioning Problem (3009)

Patient Problems Embolism (1829); Thrombosis (2100)

Event Date 07/13/2012

Event Type  Injury  

Event 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
• Type of Device: 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 ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10076476
• MDR Text Key: 191606243
• Report Number: 2134265-2020-06805
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 08714729114666
• UDI-Public: 08714729114666
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2004
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR