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

Model Number H749LVSUS250

Device Problems Entrapment of Device (1212); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problems Atrial Fibrillation (1729); No Consequences Or Impact To Patient (2199); Vascular Dissection (3160)

Event Date 09/18/2020

Event Type  Death  

Event Description

It was reported that difficulty to lock, a twisted post, jammed post and failure to re-sheath occurred a patient with a bicuspid aortic valve was selected for a 25mm lotus edge valve implant.Femoral access was achieved and an extra small safari2 guidewire was inserted into the left ventricle (lv).A 20mm non-bsc balloon was inserted and used to predilate the native aortic valve annulus.The 25mm lotus edge valve system was inserted and met resistance at the native aortic annulus.The lotus edge valve system was removed and a 22mm non-bsc balloon was inserted and used to predilate the native annulus.The safari2 guidewire was removed and a 260cm non-bsc guidewire was exchanged into the lv via a pigtail catheter.The lotus edge valve system was advanced over the non-bsc guidewire and it was discovered that the wire was too short.Upon removal of the lotus edge valve system the wire position in the lv was lost.Multiple attempts were made to recross the annulus with multiple wires and catheters.A transseptal approach was then attempted and accessed.A.021 guidewire and a catheter were inserted through the transseptal sheath and advanced to the descending aorta.A snare was used to pull the wire through the lis sheath.A pigtail catheter was then advanced through the lis sheath over the guidewire and into the lv.A non-bsc 300cm wire was then exchanged through the pigtail catheter into the lv.Upon lotus edge valve deployment and locking, resistance was met in the non cusp post-buckle connection.Multiple attempts were made to lock this connection with continued resistance.An attempt to resheath the device was met with resistance and the delivery system handle was operated to reset the locking system.Multiple attempts were continued to lock all three connections.It was confirmed through multiple angiographic views that the locking components were locked, so the physician proceeded to release the valve.Upon release of the lotus edge valve from the delivery system, the connection at the non-cusp would not release.Multiple attempts were made to free the connection unsuccessfully.The patient then underwent open heart surgery.The connection that would not release was cut and the lotus edge valve delivery system components were removed.The lotus edge valve was left implanted.The patient was reported to be stable the following morning.

Event Description

It was reported that difficulty locking, difficulty advancing, twisted post, jammed post and failure to re-sheath occurred.A patient with a type 0 bicuspid aortic valve was selected for a 25mm lotus edge valve implant.The lotus edge valve was advanced over the guidewire and across the annulus.The aortic valve was treated with deployment of a 25mm lotus edge valve.Successful repositioning of the lotus edge valve involved partial re-sheathing and deployment into a more accurate position within the aortic annulus three times, in accordance with the instructions for use (ifu).Upon the lotus edge valve deployment and locking, resistance was met in the non-cusp post-buckle connection.Multiple attempts were made to lock this connection with continued resistance.The physician then attempted to resheath the lotus edge valve, but was again met with resistance.Multiple attempts were continued to lock all three connections.It was confirmed through multiple angiographic views that the locking components were locked, so the physician proceeded to release the valve.Upon release, the lotus edge valve from the delivery system, the connection at the non-cusp would not release.Multiple attempts were made to free the connection unsuccessfully.The patient was taken to undergo an open heart surgery.The connection that would not release was cut and the lotus edge valve delivery system components were removed.The patient was reported to be stable the following morning.It was further reported that the patient also experienced an aortic dissection, atrial fibrillation and death.

• 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: 10608282
• MDR Text Key: 209228473
• Report Number: 2134265-2020-13412
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 08714729960911
• UDI-Public: 08714729960911
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2020
• Device Model Number: H749LVSUS250
• Device Catalogue Number: H749LVSUS250
• Device Lot Number: 0024989479
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2021
• Removal/Correction Number: 92630745-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 57 YR