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

Model Number	H749LVSUS230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a myocardial infarction occurred.The patient was successfully implanted with a 23mm lotus edge valve.Four days post index procedure, the patient presented and was found to have a non-st-elevation myocardial infarction involving the inferior wall.The right coronary artery was found to not be filling as it should, so the physician suspected it was due to the lotus edge valve or native leaflet location post the valve implant procedure.No action was taken to treat the myocardial infarction and there were no further patient consequences reported.
Additional Manufacturer Narrative
A2 date of birth - updated.A3 gender - updated.B2 outcomes attributed to adverse event - updated.B3 date of death - updated.B5 - updated.
Event or Problem Description
It was reported that a myocardial infarction occurred.The patient was successfully implanted with a 23mm lotus edge valve.Four days post index procedure, the patient presented and was found to have a non-st-elevation myocardial infarction involving the inferior wall.The right coronary artery was found to not be filling as it should, so the physician suspected it was due to the lotus edge valve or native leaflet location post the valve implant procedure.No action was taken to treat and there were no further patient consequences reported.On 28 apr 2022, it was reported that the patient had died on (b)(6) 2020.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10824491
• Report Number: 2134265-2020-15632
• Device Sequence Number: 11745293
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022

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: 11/10/2020
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0025817142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 87 YR
• Patient Sex: Female