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

Model Number	H749LVSUS270
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that cerebral vascular accident (cva) occurred.Pro the patients native aortic valve anatomy consisted of moderate leaflet calcification, moderate-to-severe tortuosity, and a horizontal aorta.A 27mm lotus edge valve was selected to treat aortic stenosis.During deployment, the lotus edge valve exhibited asymmetric unsheathing.The observation occurred twice; once when the valve was deployed too high and once when the valve was deployed too low.Successful repositioning of the lotus edge valve involved three partial and one complete re-sheathings and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).After the index procedure, the patient developed left sided weakness, facial droop, and had difficulty swallowing.An mri was performed which showed signs of a cva in the right middle cerebral artery.The patient was implanted with a peg tube due to the difficulty swallowing and was discharged to inpatient rehabilitation.

• 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: 10925362
• Report Number: 2134265-2020-15893
• Device Sequence Number: 4330045
• Product Code: NPT
• UDI-Device Identifier: 08714729960928
• UDI-Public: 08714729960928
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P180029
• 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
• Remedial Action: Recall,Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2020
• Device Model Number: H749LVSUS270
• Device Catalogue Number: H749LVSUS270
• Device Lot Number: 0025828996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 12/01/2020
• 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
• Patient Age: 86 YR