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

Model Number	H749LVSUS270
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Transient Ischemic Attack (2109); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulty advancing the delivery system and stroke occurred.The patient was selected for a 27mm lotus edge valve implant.Balloon aortic valvuloplasty (bav) was performed with a 20mm non-bsc balloon catheter.A 27mm lotus edge valve system was advanced.The physician encountered challenges crossing the native aortic valve with the 27mm lotus edge valve system.The guide wire and the nosecone of the 27mm lotus edge valve system were repositioned.The 27mm lotus edge valve system was then able to cross the native aortic annulus successfully.The 27mm lotus edge valve was implanted.Successful repositioning of the 27mm lotus edge valve involved re-sheathing and deployment into a more accurate, higher position within the aortic annulus, in accordance with the instructions for use (ifu).The physician encountered difficulty locking the 27mm lotus edge valve, but was successfully locked after troubleshooting with the push-pull technique.After the procedure was completed, the patient was in recovery and signs of a minor stroke were observed.The patient's prognosis is good.
Event or Problem Description
It was reported that difficulty advancing the delivery system and stroke occurred.The patient was selected for a 27mm lotus edge valve implant.Balloon aortic valvuloplasty (bav) was performed with a 20mm non-bsc balloon catheter.A 27mm lotus edge valve system was advanced.The physician encountered challenges crossing the native aortic valve with the 27mm lotus edge valve system.The guide wire and the nosecone of the 27mm lotus edge valve system were repositioned.The 27mm lotus edge valve system was then able to cross the native aortic annulus successfully.The 27mm lotus edge valve was implanted.Successful repositioning of the 27mm lotus edge valve involved re-sheathing and deployment into a more accurate, higher position within the aortic annulus, in accordance with the instructions for use (ifu).The physician encountered difficulty locking the 27mm lotus edge valve, but was successfully locked after troubleshooting with the push-pull technique.After the procedure was completed, the patient was in recovery and signs of a minor stroke were observed.The patient's prognosis is good.It was further reported that there was no difficulty or challenges crossing the native valve as previously reported.The previously reported stroke was attributed to a vasovagal response due to femoral nerve compression that presented like a stroke immediately after the procedure.The 27mm lotus edge performed as expected in the patient's challenging anatomy.The patient's symptoms resolved shortly after the procedure.The neurology team worked the patient up, including magnetic resonance imaging (mri), subsequently ruling out a stroke for this patient.The patient was discharged home the next day and is doing well.
Additional Manufacturer Narrative
B1 adverse event/product problem - updated.B2 outcomes attributed to adverse event - updated.B5 describe event or problem - updated.H6 device codes - updated.H6 patient codes - updated.H1 type of reportable event -updated.

• Brand Name: LOTUS EDGE VALVE SYSTEM
• Common Device Name: LOTUS EDGE TM VALVE SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10662517
• Report Number: 2134265-2020-13773
• Device Sequence Number: 4284406
• Product Code: NPT
• UDI-Device Identifier: 08714729960928
• UDI-Public: 08714729960928
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2020
• Device Model Number: H749LVSUS270
• Device Catalogue Number: H749LVSUS270
• Device Lot Number: 0025959283
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other