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

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem Perforation (2001)

Event Date 09/19/2019

Event Type  Injury  

Event Description

On or about (b)(6) 2000, patient was surgically implanted with a greenfield inferior vena cava (ivc) filter.On (b)(6) 2019, imaging of the patient revealed perforation occurred and the filter was noted to be fractured and tilted.On (b)(6) 2019, ct revealed a fragment from ivc filter is in the right ventricle and penetrates through the wall and into the pericardium.On (b)(6) 2019, patient underwent surgery to remove the fractured ivc filter strut from the right ventricle, the remainder of the device remains within the patient.No further patient complications have been 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: 11900767
• MDR Text Key: 253145888
• Report Number: 2134265-2021-06920
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• 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