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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM; LOTUS EDGE TM VALVE SYSTEM 23 MM
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BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM; LOTUS EDGE TM VALVE SYSTEM 23 MM Back to Search Results
Model Number 10394
Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2019
Event Type  malfunction  
Event Description
It was reported that the coupler fingers (the component that attaches the delivery system to the valve) bent.Procedure summary: the patient presented for a transcatheter aortic valve replacement procedure with a lotus edge valve.An unspecified pigtail catheter was inserted via the left femoral artery.The lotus edge valve system was inserted via the right femoral artery.The valve was released and was functioning perfectly.While resheathing the coupler fingers for removal of the lotus edge delivery system, the pigtail catheter got caught between the coupler fingers.The pigtail catheter was pulled back prior to resheathing, as per instructions for use (ifu), but had not been pulled back high enough.An attempt to straighten the pigtail catheter with a guidewire was unsuccessful.The lotus edge delivery system was then pulled to the descending aorta.Multiple attempts to free the pigtail catheter were unsuccessful.A decision was made to cut a portion of the pigtail catheter outside of the patients body.The pigtail catheter and guidewire were pulled out together with the lotus edge delivery system fully resheathed.After removal from the patient one of the coupler fingers on the delivery system was bent upwards.The function of the valve was assessed as perfect.There were no adverse patient effects.
 
Event Description
It was reported that the coupler fingers (the component that attaches the delivery system to the valve) bent.Procedure summary: the patient presented for a transcatheter aortic valve replacement procedure with a lotus edge valve.An unspecified pigtail catheter was inserted via the left femoral artery.The lotus edge valve system was inserted via the right femoral artery.The valve was released and was functioning perfectly.While resheathing the coupler fingers for removal of the lotus edge delivery system, the pigtail catheter got caught between the coupler fingers.The pigtail catheter was pulled back prior to resheathing, as per instructions for use (ifu), but had not been pulled back high enough.An attempt to straighten the pigtail catheter with a guidewire was unsuccessful.The lotus edge delivery system was then pulled to the descending aorta.Multiple attempts to free the pigtail catheter were unsuccessful.A decision was made to cut a portion of the pigtail catheter outside of the patients body.The pigtail catheter and guidewire were pulled out together with the lotus edge delivery system fully resheathed.After removal from the patient one of the coupler fingers on the delivery system was bent upwards.The function of the valve was assessed as perfect.There were no adverse patient effects.
 
Manufacturer Narrative
Lotus edge delivery system (23318620-23) was returned for analysis with the sterilization bottle and bottle components.A section of the pigtail catheter was also received.The pigtail catheter had been cut 37cm from distal end and a kink was also observed 7cm from distal end.It was stated in the complaint report that the pigtail was cut outside the patient so that it could be pulled out together with the delivery system as the operators did not want to unsheath the delivery system again.The lotus edge delivery system was unsheathed on receipt and it was observed that all 3 coupler fingers were inverted.As part of this complaint investigation a review of the procedural media was performed by a bsc quality engineer.The available media shows the implantation of a lotus edge valve.Following the release of the valve, there is a gap in cine recordings and the next series is of the catheter in the descending aorta with what appears to be part of the pigtail catheter extending out of the outer sheath.The resheathing of the catheter following valve release and the reported interaction with the pigtail was not shown in the available media.The pigtail catheter was observed to be at the level of the locked valve during the final contrast assessment before the valve is released.The final contrast assessment taken through the new pigtail indicated a good result with no aortic insufficiency.The procedural media shows the coupler fingers in their correct configuration within the outer sheath as the device was removed from the patient.It was also stated that the delivery system was unsheathed outside the patient to remove the pigtail and one of the fingers was noted to be bent upwards.The coupler fingers can invert when the catheter is unsheathed with the outer sheath straightened; this is not a defect however a natural state for the coupler fingers when the catheter is unsheathed in a straight configuration.No other damage or issues were noted.The reported interaction between the coupler fingers and the pigtail could not be confirmed as the valve release and the sheathing of the catheter was not shown in the media provided.The catheter is observed in the descending aorta with what appears to be part of the pigtail catheter extending out of the outer sheath following the release of the valve.
 
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Brand Name
LOTUS EDGE VALVE SYSTEM
Type of Device
LOTUS EDGE TM VALVE SYSTEM 23 MM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8818269
MDR Text Key151940493
Report Number2134265-2019-08256
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
PMA/PMN Number
P180029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/16/2019
Device Model Number10394
Device Catalogue Number10394
Device Lot Number0023341917
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2019
Date Manufacturer Received08/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age78 YR
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