MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM; LOTUS EDGE TM VALVE SYSTEM

Model Number 10394

Device Problems Device Difficult to Setup or Prepare (1487); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

(b)(6) study.It was reported that an inability to unsheath the valve occurred.Prior to the index procedure, a 25mm lotus edge valve (lot # 0024743658) was found damaged when removed from packaging.A lotus introducer was inserted and a second 25mm lotus edge valve (lot # 0025692590) was inserted, however could not be deployed due to difficulty in unsheathing the valve.The second 25mm lotus edge valve (lot# 0025692590) was removed from the patient after attempts to deploy again failed.A 26mm non-boston scientific valve was successfully implanted into the proper anatomical location.There were no patient complications.

Event Description

Respond edge study.It was reported that a failure to unsheath the valve occurred.Prior to the index procedure, a 25mm lotus edge valve ( lot # 0024743658) was found damaged when removed from packaging.A lotus introducer was inserted and a second 25mm lotus edge valve (lot # 0025692590) was inserted, however could not be deployed due to difficulty in unsheathing the valve.The second 25mm lotus edge valve (lot# 0025692590) was removed from the patient after attempts to deploy again failed.A 26mm non-boston scientific valve was successfully implanted into the proper anatomical location.There were no patient complications.It was further reported that the procedure time was lengthened due to this incident with an with increased quantity of contrast product and x-rays delivered; there were no clinical complications observed.The patient has been discharged from the hospital.

Manufacturer Narrative

A1 patient identifier: (b)(6).H3 device eval by manufacturer: the device was received with the nosecone over seated.An examination of the outer sheath identified no damages.During device analysis a stylet was inserted through the nosecone section of the device with no restrictions noted.As part of the functional testing the device was unsheathed with no restrictions noted.An examination of the valve components identified no damages.The valve locked without issue and re-sheathed.Finally the valve was released with no restrictions noted.No damage was observed with the valve.The review of the available media shows the lotus edge device initially positioned in the annulus.The series goes on to show the lotus edge device in the descending aorta and the re-advancing back over the aortic arch through the annulus.A gap between the outer sheath and the nosecone is not clearly visible in the media review.This could indicate that the nosecone could potentially have been over-seated during advancement to the annulus.Any restrictions experienced during the valve release is not captured in the media review.The withdrawal of the lotus edge device is not captured.The final assessment shots shows a non-bsc valve to be well positioned.

• 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 Key: 10417737
• MDR Text Key: 203301874
• Report Number: 2134265-2020-11015
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Model Number: 10394
• Device Catalogue Number: 10394
• Device Lot Number: 0025692590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR