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

Device Problems Break (1069); Migration (4003)

Patient Problem Ventricular Tachycardia (2132)

Event Date 09/06/2019

Event Type  Injury  

Event Description

Reported via medwatch # 5089660 it was reported that a device fracture and embolization occurred.The patient had a greenfield filter implanted on an unknown date.It was discovered that the filter was fractured and part of one leg (approx 2/3) had embolized to the right ventricle, likely causing ventricular tachycardia.The patient stabilized and an attempt at percutaneous removal was made, but it was unsuccessful.The patient is being considered for open heart surgery to remove the piece of the device.The remaining part of the filter leg is embedded in the spine.The remainder of the filter is intact and there is no plan to remove it.

• Brand Name: GREENFIELD
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9209497
• MDR Text Key: 162871330
• Report Number: 2134265-2019-12531
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention