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

Device Problem Positioning Problem (3009)

Patient Problems Embolism (1829); Perforation (2001)

Event Date 04/25/2006

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown; therefore, date is approximated.

Event Description

A greenfield filter was implanted on (b)(6) 2006.On an unknown date it was noted there was a perforation.The filter was noted to be tilted.No further patient complications were reported.

Event Description

A greenfield filter was implanted on(b)(6) 2006.On an unknown date it was noted there was a perforation.The filter was noted to be tilted.No further patient complications were reported.It was further reported that a patient was involved in motor vehicle accident in (b)(6) 2006, that caused splenic injury, rib fractures and hematoma formation.The patient did not require any surgical intervention and was discharged to home.The patient was doing well with mild complaints of back pain, but noticed over the last several days that she had left lower extremity swelling.The patient did have venous doppers, which demonstrated deep vein thrombosis.The patient was admitted and a greenfield filter was implanted for protection of a pulmonary embolism.It was placed instead of prophylactic therapy for deep venous thrombosis because of the high risk of bleeding.A ct scan that was done had suggestions of possible evidence of clots within the pulmonary vasculature.The patient was discharged home.Four days later the patient was readmitted for a large right-sided pulmonary embolism, which was suspected to be present prior to the filter placement.The patient was asymptomatic but was started on a full dose of lovenox therapy at treatment doses.A ct abdomen performed in (b)(6) 2017 confirmed the filter was in place, with its tip at the level of the lowermost renal vein.It was rotated clockwise to the long axis of the ivc approximately 15 degrees.No strut fracture was demonstrated.The tips of the struts project peripheral to the visualized margin of the ivc along the anterior and lateral aspects, maximal protrusion approximate 4mm.They do not protrude into vital structures.The nose of the ivc filter was positioned against the left posterolateral wall of the ivc near the left renal vein ostium.

• Brand Name: GREENFIELD
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9837283
• MDR Text Key: 183720893
• Report Number: 2134265-2020-03286
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 03/23/2020
• Supplement Dates FDA Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR