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

Model Number	H749LVSUS270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
A1 patient id: pid-(b)(6).With all the available information, boston scientific (bsc) concludes: device history record review a review was completed of the device history records (dhr) for the lotus edge valve, part # h749lvsus270, batch # 0024989623.The device was processed through all normal operational conditions and passed all acceptance activities.The dhr review did not identify any deviations or non-conformances that could have contributed to the event.Device technical analysis the lotus edge valve remains implanted, therefore returned device analysis could not be completed.Labeling review there was no evidence to suggest that the device was used in a manner inconsistent with the labeling.The lotus valve product directions for use lists adverse events potentially associated with transcatheter aortic valve implantation as well as additional risks related to the use of the lotus valve system which includes death.As a result of this adverse event, the subject may require medical, percutaneous or surgical intervention, including re-operation and replacement of the valve.These events may led to fatal outcomes.Risk review a risk review was completed and confirmed that the event of death was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion bsc has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that patient death occurred.A 27mm lotus edge valve was implanted on (b)(6) 2020.On (b)(6) 2026 the patient died.

• Brand Name: LOTUS EDGE? VALVE SYSTEM
• Common Device Name: LOTUS EDGE TM VALVE SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 25385134
• Report Number: 2124215-2026-29809
• Device Sequence Number: 10410578
• Product Code: NPT
• UDI-Device Identifier: 08714729960928
• UDI-Public: (01)08714729960928(17)201008(10)24989623
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P180029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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: 10/08/2020
• Device Model Number: H749LVSUS270
• Device Catalogue Number: H749LVSUS270
• Device Lot Number: 0024989623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 06/03/2026
• Date Device Manufactured: 01/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92630745-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown