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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
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BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM; LOTUS EDGE TM VALVE SYSTEM Back to Search Results
Model Number 10394
Device Problems Difficult to Remove (1528); Use of Device Problem (1670); Device-Device Incompatibility (2919); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2020
Event Type  malfunction  
Event Description
It was reported that resheathing failure occurred.The patient's anatomy was moderately tortuous.A 27mm lotus edge valve was advanced through the right femoral artery and a non-bsc pigtail catheter was advanced through the left femoral artery.The lotus edge valve was successfully implanted.While resheathing the lotus edge delivery system for removal, the pigtail catheter got caught in the delivery system.A guidewire was placed inside the pigtail catheter to try to straighten and free the pigtail, however, this was unsuccessful.The pigtail was able to be released by unsheathing the lotus edge delivery system.The lotus edge delivery system was then carefully retrieved into the descending aorta, where resheathing of the delivery system was attempted.It was not possible to resheath the sheathing aids.The implanters proceed with removing the lotus edge delivery system in the unsheathed state.The lotus edge delivery system got stuck in the lotus introducer sheath and had to be removed together.No patient harm occurred, the patient is well.
 
Manufacturer Narrative
H3 device evaluated by manufacturer: the lotus edge delivery system was returned for evaluation.No valve was returned as it was successfully implanted in the patient.The handle was noted to be in release phase two upon receipt.The device was returned with the distal outer sheath stuck inside a lotus introducer sheath (lis).The distal components of the delivery system were visible, and the distal outer sheath was accordioned at multiple locations.The handle housing was removed to assess the position of the slider.The slider/ force limiter was found to be at the very back of the handle, which indicates that when the delivery system was unsheathed in an attempt to free up the distal components, the slider didn't re-engage with the force limiter carriage.This is known to cause excessive coupler finger bowing.Two coupler fingers were visible during initial analysis.The outer sheath of the lotus edge delivery system was cut to allow the lis to be removed.Further examination of the distal components confirmed that one coupler finger had bent down into the catheter and had curved back up.A review of the available media confirmed that the pigtail catheter was positioned deep in the ncc throughout the procedure and during final locking confirmation.In accordance with the lotus edge field training documents, the pigtail catheter should be pulled back during locking confirmation and valve release.It is likely that subsequent sheathing and unsheathing of the delivery system in an attempt to release the entangled pigtail catheter resulted in the disengagement of the slider and the force limiter carriage.This is known to result in excessive coupler finger bowing.
 
Event Description
It was reported that resheathing failure occurred.The patient's anatomy was moderately tortuous.A 27mm lotus edge valve was advanced through the right femoral artery and a non-bsc pigtail catheter was advanced through the left femoral artery.The lotus edge valve was successfully implanted.While resheathing the lotus edge delivery system for removal, the pigtail catheter got caught in the delivery system.A guidewire was placed inside the pigtail catheter to try to straighten and free the pigtail, however, this was unsuccessful.The pigtail was able to be released by unsheathing the lotus edge delivery system.The lotus edge delivery system was then carefully retrieved into the descending aorta, where resheathing of the delivery system was attempted.It was not possible to resheath the sheathing aids.The implanters proceed with removing the lotus edge delivery system in the unsheathed state.The lotus edge delivery system got stuck in the lotus introducer sheath and had to be removed together.No patient harm occurred, the patient is well.
 
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Brand Name
LOTUS EDGE VALVE SYSTEM
Type of Device
LOTUS EDGE TM VALVE SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10101334
MDR Text Key193417974
Report Number2134265-2020-06793
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/05/2020
Device Model Number10394
Device Catalogue Number10394
Device Lot Number0024703705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2020
Date Manufacturer Received06/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age82 YR
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