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

Model Number	H749LVSUS270
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that major hemorrhage occurred.The patient, with calcium at the native annulus, leaflets, and left ventricular outflow tract, was selected for a 27mm lotus edge valve implant.After the 27mm lotus edge valve (batch 24309261) was deployed, asymmetric unsheathing and a twisted post was observed.The physician's tried twice to mitigate the observations by re-sheathing and deploying into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu) however, was unsuccessful.A second 27mm lotus edge valve (batch 24325029) was prepared and the first valve was removed.The second valve was deployed and again during deployment stage 1, exhibited asymmetric unsheathing.The second 27mm lotus edge valve was re-sheathed and then fully deployed into a deeper, more accurate position within the aortic annulus, in accordance with the instructions for use (ifu) which successfully mitigated the observation.Two days post index procedure, major hemorrhage occurred.

• 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: 10925153
• Report Number: 2134265-2020-16308
• Device Sequence Number: 14517666
• Product Code: NPT
• UDI-Device Identifier: 08714729960928
• UDI-Public: 08714729960928
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P180029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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: 05/28/2020
• Device Model Number: H749LVSUS270
• Device Catalogue Number: H749LVSUS270
• Device Lot Number: 0024325029
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 12/01/2020
• 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: Other
• Patient Age: 78 YR