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	Arrhythmia (1721); Death (1802)
Date of Event	05/18/2020
Type of Reportable Event	Death
Event or Problem Description
(b)(6) study.It was reported that incomplete left bundle branch block (lbbb) occurred.The patient was enrolled into (b)(6) study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given.The patient was not on prior regimen of aspirin at the time of index procedure.A loading dose of aspirin was given prior to the procedure.A lotus introducer was placed and the aortic valve was treated with deployment of a 25mm lotus edge valve.On the same day of the index procedure, the patient was diagnosed with incomplete lbbb.In response to the event, electrophysiology study was performed as diagnostic.One (1) day post index procedure, a permanent pacemaker was implanted.Three (3) days post index procedure, the patient was discharged on 81 mg of aspirin.
Additional Manufacturer Narrative
Outcomes attributed to adverse event: updated.Date of death: updated.Describe event or problem: updated.Type of reportable event: updated.Patient codes: updated.
Event or Problem Description
Protected tavr study: it was reported that incomplete left bundle branch block (lbbb) occurred.The patient was enrolled into the protected tavr study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given.The patient was not on prior regimen of aspirin at the time of index procedure.A loading dose of aspirin was given prior to the procedure.A lotus introducer was placed and the aortic valve was treated with deployment of a 25mm lotus edge valve.On the same day of the index procedure, the patient was diagnosed with incomplete lbbb.In response to the event, electrophysiology study was performed as diagnostic.One (1) day post index procedure, a permanent pacemaker was implanted.Three (3) days post index procedure, the patient was discharged on 81 mg of aspirin.It was further reported that in (b)(6) 2020, the patient passed away.Cause of death is unknown.

• 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: 10471464
• Report Number: 2134265-2020-11126
• Device Sequence Number: 2751082
• Product Code: NPT
• UDI-Device Identifier: 08714729960911
• UDI-Public: 08714729960911
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 11/25/2020

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: 06/27/2020
• Device Model Number: H749LVSUS250
• Device Catalogue Number: H749LVSUS250
• Device Lot Number: 0024490506
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: 77 YR