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

Model Number H749LVSUS270

Device Problem Premature Activation (1484)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); No Consequences Or Impact To Patient (2199)

Event Date 06/15/2020

Event Type  Injury  

Event Description

It was reported that the lotus edge valve prematurely released.The lotus edge valve released prior to full and complete rotation of the release collar to a hard stop.It appeared as if the valve got released a click or two beyond pause.The implant was successful and the patient was noted to be fine at the end of the procedure.

Manufacturer Narrative

B5:describe event or problem: updated.H6:patient codes: updated.

Event Description

It was reported that the lotus edge valve prematurely released.The lotus edge valve released prior to full and complete rotation of the release collar to a hard stop.It appeared as if the valve got released a click or two beyond pause.The implant was successful and the patient was noted to be fine at the end of the procedure.It was further reported that post procedure new pathological q-wave or left bundle branch block(lbbb), and cardiac arrest occurred.

• Brand Name: LOTUS EDGE VALVE SYSTEM
• Type of Device: LOTUS EDGE TM VALVE SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10254743
• MDR Text Key: 198328273
• Report Number: 2134265-2020-08551
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 08714729960928
• UDI-Public: 08714729960928
• Combination Product (y/n): N
• PMA/PMN Number: P180029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: H749LVSUS270
• Device Catalogue Number: H749LVSUS270
• Device Lot Number: 0024835356
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2020
• Removal/Correction Number: 92630745-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Other