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

Model Number 43175

Device Problems Positioning Problem (3009); Migration (4003)

Patient Problems Perforation (2001); Tissue Damage (2104)

Event Date 04/01/2005

Event Type  Injury  

Event Description

A greenfield filter was implanted on (b)(6) 2005.On (b)(6) 2005 it was noted there was perforation.The filter was noted to be tilted and migration had occurred.No further patient complications were reported.

Event Description

A greenfield filter was implanted on (b)(6) 2005.On (b)(6) 2005 it was noted there was perforation.The filter was noted to be tilted and migration had occurred.No further patient complications were reported.It was further reported that the patient was involved in a motor vehicle accident sustaining cerebral injury and subarachnoid hemorrhage.The patient was diagnosed with left femoral deep venous thrombosis.The greenfield filter was implanted to prevent pulmonary embolus.Under fluoroscopic guidance, the sheath was retracted onto the greenfield filter introducer catheter and secured; the filter position was ascertained and it was deployed.The filter did not open and it stayed compressed and did not seat itself in the inferior vena cava.It was seen migrating proximally.Fluoroscopy was used to examine the chest, and its position was confirmed in the left pulmonary artery.The filter was percutaneously retrieved with a snare.During retrieval, there was damage to the pulmonary and tricuspid valves.The patient was transported back to the neuro critical care unit in stable condition.The patient was discharged on (b)(6) 2005.On (b)(6) 2006, the patient had surgery to repair the pulmonary and tricuspid valves.

• 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: 9823646
• MDR Text Key: 183492535
• Report Number: 2134265-2020-03026
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 08714729114666
• UDI-Public: 08714729114666
• Combination Product (y/n): N
• PMA/PMN Number: K901659
• 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

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2008
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0007491431
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR