MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE; LOTUS EDGE TM VALVE SYSTEM 23 MM

Model Number	H749LVSUS230
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Arrhythmia (1721); Pericardial Effusion (3271)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: birth year (b)(6).
Event or Problem Description
Reportable based on additional information received 01 june 2020.It was reported that difficulty advancing the lotus edge delivery system through the introducer occurred.Vascular access was obtained via transfemoral approach.An isleeve introducer sheath was placed.A 23mm lotus edge valve system was prepared for use.When the physician advanced the 23mm lotus edge valve delivery system, the physician encountered extreme resistance.Eventually, the physician was able to advance the 23mm lotus edge valve delivery system through the isleeve introducer sheath.The 23mm lotus edge valve was successfully implanted.There was a small pericardial effusion noted; however, it was 'very, very, very small' in size.The patient was observed for 30 minutes.The effusion did not grow, so the physicians were not concerned with it.It was further reported that a new pathological q-wave or left bundle branch block (lbbb) occurred requiring a pace maker occurred post procedure.

• Brand Name: LOTUS EDGE VALVE
• Common Device Name: LOTUS EDGE TM VALVE SYSTEM 23 MM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10192116
• Report Number: 2134265-2020-07948
• Device Sequence Number: 886849
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2020

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: 03/14/2020
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0023940184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention