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)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that complete heart block (chb) and left bundle branch block (lbbb) occurred.The patient anatomy consisted of small peripheral arteries.A 15f isleeve introducer sheath was inserted into the left femoral artery with no issue.A 23mm lotus edge valve was successfully implanted.Post valve implant, the patient developed lbbb.A temporary pacemaker remained in the patient following completion of the procedure.One day post procedure, during a follow-up echocardiogram, the patient was observed to have an episode of symptomatic chb.The chb resolved on its own and electrophysiology was consulted.In addition, the patient's left foot was observed to be pulseless.The loss of a pulse was suspected to be caused by a clot following the implant procedure.A heparin drip was initiated and the event resolved.At the time of reporting, the patient was still hospitalized.

• 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: 10879486
• Report Number: 2134265-2020-15788
• Device Sequence Number: 2559145
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 11/20/2020

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: 11/10/2020
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0025941653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/20/2020
• 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: Required Intervention
• Patient Age: 82 YR