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 Codes	Arrhythmia (1721); Complete Heart Block (2627); Heart Block (4444)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) study.It was reported that complete atrioventricular (av) block occurred.The patient was enrolled into the (b)(6) study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was on a prior regimen of antiplatelet medications and aspirin.After heparin was given and during the start of the procedure, the activated clotting time (act) was 274 sec.An isleeve introducer sheath was placed and the aortic valve was treated with balloon valvuloplasty and subsequent deployment of a 23mm lotus edge valve.One day post index procedure, the patient was diagnosed with av block.An electrophysiology study was performed as a diagnostic and a permanent pacemaker was implanted.Two days post index procedure, the patient was discharged on 81 mg of aspirin.
Event or Problem Description
Protected tavr study: it was reported that complete atrioventricular (av) block 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 and the patient was on a prior regimen of antiplatelet medications and aspirin.After heparin was given and during the start of the procedure, the activated clotting time (act) was 274 sec.An isleeve introducer sheath was placed and the aortic valve was treated with balloon valvuloplasty and subsequent deployment of a 23mm lotus edge valve.One day post index procedure, the patient was diagnosed with av block.An electrophysiology study was performed as a diagnostic and a permanent pacemaker was implanted.Two days post index procedure, the patient was discharged on 81 mg of aspirin.It was further reported that during the index procedure, post-dilation of the lotus edge valve was performed.1-day post index procedure, the patient was diagnosed with left bundle branch block(lbbb) for which outpatient follow-up was performed.On the same day, the complete av block was considered recovered.The lbbb was considered recovered the following day.
Additional Manufacturer Narrative
B5: describe event or problem: updated.H6: patient codes: updated.

• 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: 10971418
• Report Number: 2134265-2020-17151
• Device Sequence Number: 17217235
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: 07/11/2021
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0025696874
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 04/09/2021
• 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: Other
• Patient Age: 86 YR