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

Model Number 43335

Device Problems Positioning Failure (1158); Positioning Problem (3009); Migration (4003)

Patient Problems Perforation of Vessels (2135); No Consequences Or Impact To Patient (2199)

Event Date 05/31/2019

Event Type  Injury  

Event Description

It was reported that a perforation occurred and the filter migrated.A greenfield filter was planned to be implanted in the patient.The procedure started with a femoral access.Once the implant site was determined, the femoral filter was prepared, but it did not deploy correctly.The implant site puncture resulted in a hematoma.This hematoma required no intervention.The medical staff checked for stability and decided it was not a significant problem so the procedure was continued.Since there was no other femoral filters available, a new access site was made at the jugular level.Contrast was injected through the filter dilator.The physician observe some leak, but concluded that this was at the level of the previous femoral puncture.The implantation site for the jugular filter was then decided based on previous marks at the c arm screen.The filter was deployed according to the procedure, but the legs seemed to be not fully opened.Imaging showed that the device only opened about 20%.The medical staff seemed to think that the filter was deployed outside the vascular system at the ilium bone level, instead of the vena cava where the physician was trying to deploy it.The filter is believed to be outside the venous system, probably in a muscle.It is also believed that the system perforated the vein at some level, however no vital signs were altered, so the procedure continued.There was no more contrast so no control image was made.The procedure then ended and the patient was reported stable.Since the patients previous disease was a column lesion, there were other medical interventions made during the patients stay at the hospital.In addition, their movement was severely limited by the previous comorbidities, there was no assessment of any filter related injury.It has not been planned to remove the filter.The patient remains hospitalized and in need of a spine surgery.

Event Description

It was reported that a perforation occurred and the filter migrated.A greenfield filter was planned to be implanted in the patient.The procedure started with a femoral access.Once the implant site was determined, the femoral filter was prepared, but it did not deploy correctly.The implant site puncture resulted in a hematoma.This hematoma required no intervention.The medical staff checked for stability and decided it was not a significant problem so the procedure was continued.Since there was no other femoral filters available, a new access site was made at the jugular level.Contrast was injected through the filter dilator.The physician observe some leak, but concluded that this was at the level of the previous femoral puncture.The implantation site for the jugular filter was then decided based on previous marks at the c arm screen.The filter was deployed according to the procedure, but the legs seemed to be not fully opened.Imaging showed that the device only opened about 20%.The medical staff seemed to think that the filter was deployed outside the vascular system at the ilium bone level, instead of the vena cava where the physician was trying to deploy it.The filter is believed to be outside the venous system, probably in a muscle.It is also believed that the system perforated the vein at some level, however no vital signs were altered, so the procedure continued.There was no more contrast so no control image was made.The procedure then ended and the patient was reported stable.Since the patients previous disease was a column lesion, there were other medical interventions made during the patients stay at the hospital.In addition, their movement was severely limited by the previous comorbidities, there was no assessment of any filter related injury.It has not been planned to remove the filter.The patient remains hospitalized and in need of a spine surgery.

Manufacturer Narrative

Patient code updated.

• 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: 8798630
• MDR Text Key: 151309503
• Report Number: 2134265-2019-08100
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K964284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention