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); Stroke/CVA (1770); Myocardial Infarction (1969)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) study.It was reported that left bundle branch block (lbbb) and 1st degree atrioventricular(av) block occurred.Prior to index procedure, heparin or another anticoagulant was given.The subject was on prior regimen of aspirin at the time of index procedure.The subject received a loading dose of aspirin.After heparin was given and prior to sentinel device insertion, the activated clotting time (act) was 318 sec.An introducer sheath was placed into the right radial artery and the sentinel cerebral protection system was deployed with the proximal filter into the brachiocephalic artery and distal filter into the left common carotid artery.An introducer sheath was then placed and then the native aortic valve was treated with direct deployment of a 23mm lotus edge valve involving repositioning into the proper anatomical location.The sentinel system was then successfully retrieved without any complications.On the same day of the index procedure, the subject was diagnosed with lbbb and 1st degree av block.Electrocardiogram and electrophysiology were performed as diagnostics for both the events.The events were treated with implantation of a dual-chamber right-sided pacemaker without complications.Two days later, the events were considered recovered, and the subject was discharged on 81 mg of aspirin.
Event or Problem Description
Protected tavr study.It was reported that left bundle branch block (lbbb) and 1st degree atrioventricular(av) block occurred.Prior to index procedure, heparin or another anticoagulant was given.The subject was on prior regimen of aspirin at the time of index procedure.The subject received a loading dose of aspirin.After heparin was given and prior to sentinel device insertion, the activated clotting time (act) was 318 sec.An introducer sheath was placed into the right radial artery and the sentinel cerebral protection system was deployed with the proximal filter into the brachiocephalic artery and distal filter into the left common carotid artery.An introducer sheath was then placed and then the native aortic valve was treated with direct deployment of a 23mm lotus edge valve involving repositioning into the proper anatomical location.The sentinel system was then successfully retrieved without any complications.On the same day of the index procedure, the subject was diagnosed with lbbb and 1st degree av block.Electrocardiogram and electrophysiology were performed as diagnostics for both the events.The events were treated with implantation of a dual-chamber right-sided pacemaker without complications.Two days later, the events were considered recovered, and the subject was discharged on 81 mg of aspirin.It was further reported that three days post index procedure, the patient experienced a cerebral vascular accident and myocardial infarction.

• 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: 10612846
• Report Number: 2134265-2020-13473
• Device Sequence Number: 2719886
• 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): 03/04/2021

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: 12/08/2020
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0025817141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 03/05/2021
• 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: Required Intervention
• Patient Age: 80 YR