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

Model Number	H749LVSUS230
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that left bundle branch block (lbbb) and embolization occurred.The native aortic annulus was 22.5mm in diameter with mild to moderate leaflet calcification.A 23 mm lotus edge valve was selected for implant.During deployment of the lotus edge valve there was a mild waist on the noncoronary cusp side and the implant depth was approximately -3 to -4 mm.A new onset lbbb occurred.The lotus edge valve was released.After release, the sheathing aid near the left coronary cusp got stuck.The sheathing aid appeared perpendicular to the valve frame.After approximately 90 to 120 seconds of gentle pulling and wire advancement, the sheathing aids freed.Upon release of the sheathing aids, the lotus edge valve moved 15-20mm superior into the sinotubular junction.The physicians opted for surgery where the lotus edge valve was explanted and a 21mm surgical valve was implanted.The surgery went without any complications.The patient is stable and recovering.

• 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: 10553535
• Report Number: 2134265-2020-12779
• Device Sequence Number: 14154069
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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: 11/14/2020
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0025844974
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR