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

Model Number	H749LVSUS250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Complete Heart Block (2627)
Date of Event	09/23/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported that complete heart block occurred.The patient was selected for a 25mm lotus edge valve implant.A right transfemoral access was gained.After the successful lotus edge valve implant, the patient was observed to have complete heart block.A permanent pacemaker was implanted to treat the event.
Additional Manufacturer Narrative
B2: date of death: updated.B5: describe event or problem: updated.H1: type of reportable event: updated.H6: patient codes: added death.
Event or Problem Description
It was reported that complete heart block occurred.The patient was selected for a 25mm lotus edge valve implant.A right transfemoral access was gained.After the successful lotus edge valve implant, the patient was observed to have complete heart block.A permanent pacemaker was implanted to treat the event.It was further reported that the patient was discharged two days post index procedure and died later that night at home.The cause of death is unknown.
Additional Manufacturer Narrative
Patient identifier: updated.Date of death: corrected from (b)(6) 2020 to (b)(6) 2020.Describe event or problem: updated.
Event or Problem Description
It was reported that complete heart block occurred.The patient was selected for a 25mm lotus edge valve implant.A right transfemoral access was gained.After the successful lotus edge valve implant, the patient was observed to have complete heart block.A permanent pacemaker was implanted to treat the event.It was further reported that the patient was discharged two days post index procedure and died later that night at home.The cause of death is unknown.It was further reported that the patient died 4 days post procedure, not 2 days as previously reported.

• 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: 10616519
• Report Number: 2134265-2020-13528
• Device Sequence Number: 19584234
• Product Code: NPT
• UDI-Device Identifier: 08714729960911
• UDI-Public: 08714729960911
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2020

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: 01/22/2021
• Device Model Number: H749LVSUS250
• Device Catalogue Number: H749LVSUS250
• Device Lot Number: 0025457266
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 09/28/2020; 11/12/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 10/13/2020; 12/09/2020
• 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; Required Intervention
• Patient Age: 65 YR