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

Model Number 10418

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Aortic Insufficiency (1715); Pulmonary Edema (2020); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/03/2020

Event Type  Injury  

Event Description

(b)(6) study.It was reported that aortic regurgitation occurred.The patient was enrolled into the (b)(6) study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was on a prior regimen of aspirin.A loading dose of 324 mg of aspirin and 300 mg of clopidogrel were given the day of the procedure.An isleeve introducer was placed and the 25 mm lotus edge valve was positioned.The 25 mm lotus edge valve was noted to be oriented in a very vertical position hugging the inner curvature of the aorta, which was severely rotated.This made the 25 mm lotus edge valve sit quite deep on the left coronary side.Deployment of the 25 mm lotus edge valve at multiple different depths revealed poor positioning and inadequate contact with annulus.The 25 mm lotus edge valve also noted to have no waist in it and was shaped like a barrel.The physician determined that this would not be safe to deploy due to embolization risk, so the 25 mm lotus edge valve was removed and a 27 mm lotus edge valve was implanted.Repositioning of the 27 mm lotus edge valve involved partial and complete re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).The patient was observed to have severe aortic regurgitation post attempt to deploy both lotus edge valves.A 29 mm non-boston scientific valve was then attempted, but could not be deployed post repositioning at multiple depths due to the verticality of deployment and the angle of the aorta.Finally, a different 26 mm non-boston scientific valve was implanted successfully.

Event Description

Reprise iv study.It was reported that aortic regurgitation occurred.The patient was enrolled into the reprise iv study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was on a prior regimen of aspirin.A loading dose of 324 mg of aspirin and 300 mg of clopidogrel were given the day of the procedure.An isleeve introducer was placed and the 25 mm lotus edge valve was positioned.The 25 mm lotus edge valve was noted to be oriented in a very vertical position hugging the inner curvature of the aorta, which was severely rotated.This made the 25 mm lotus edge valve sit quite deep on the left coronary side.Deployment of the 25 mm lotus edge valve at multiple different depths revealed poor positioning and inadequate contact with annulus.The 25 mm lotus edge valve also noted to have no waist in it and was shaped like a barrel.The physician determined that this would not be safe to deploy due to embolization risk, so the 25 mm lotus edge valve was removed and a 27 mm lotus edge valve was implanted.Repositioning of the 27 mm lotus edge valve involved partial and complete re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).The patient was observed to have severe aortic regurgitation post attempt to deploy both lotus edge valves.A 29 mm non-boston scientific valve was then attempted, but could not be deployed post repositioning at multiple depths due to the verticality of deployment and the angle of the aorta.Finally, a different 26 mm non-boston scientific valve was implanted successfully.It was further reported that the severe aortic regurgitation was treated medically.On the day of the index procedure, the event was considered to be resolved.

Manufacturer Narrative

Device evaluated by mfr: the 27mm lotus edge valve was returned for device analysis.The handle was returned in the starting position.The nosecone of the delivery system was noted to be over-seated.The guidewire, multi lumen extrusion and outer sheath ports of the delivery system were each flushed with 15ml saline.The lotus edge valve was then unsheathed, locked and released without issue.No visible issues were noted.

Event Description

Reprise iv study.It was reported that aortic regurgitation occurred.The patient was enrolled into the reprise iv study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was on a prior regimen of aspirin.A loading dose of 324 mg of aspirin and 300 mg of clopidogrel were given the day of the procedure.An isleeve introducer was placed and the 25 mm lotus edge valve was positioned.The 25 mm lotus edge valve was noted to be oriented in a very vertical position hugging the inner curvature of the aorta, which was severely rotated.This made the 25 mm lotus edge valve sit quite deep on the left coronary side.Deployment of the 25 mm lotus edge valve at multiple different depths revealed poor positioning and inadequate contact with annulus.The 25 mm lotus edge valve also noted to have no waist in it and was shaped like a barrel.The physician determined that this would not be safe to deploy due to embolization risk, so the 25 mm lotus edge valve was removed and a 27 mm lotus edge valve was implanted.Repositioning of the 27 mm lotus edge valve involved partial and complete re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).The patient was observed to have severe aortic regurgitation post attempt to deploy both lotus edge valves.A 29 mm non-boston scientific valve was then attempted, but could not be deployed post repositioning at multiple depths due to the verticality of deployment and the angle of the aorta.Finally, a different 26 mm non-boston scientific valve was implanted successfully.It was further reported that the severe aortic regurgitation was treated medically.On the day of the index procedure, the event was considered to be resolved.It was further reported that after removal of the 27mm lotus edge valve and the severe aortic regurgitation was observed, the patient also developed pulmonary edema which was treated with bipap and lasix.The procedure was not continued immediately.Pulmonary edema was not evident on chest x-ray.Two days post index procedure, the patient was discharged home on aspirin and clopidogrel.

Manufacturer Narrative

B5 describe problem or event updated.B7 other relevant history updated.Device evaluated by mfr: the 27mm lotus edge valve was returned for device analysis.The handle was returned in the starting position.The nosecone of the delivery system was noted to be over-seated.The guidewire, multi lumen extrusion and outer sheath ports of the delivery system were each flushed with 15ml saline.The lotus edge valve was then unsheathed, locked and released without issue.No visible issues were noted.

• 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: 11039556
• MDR Text Key: 222402672
• Report Number: 2134265-2020-18168
• Device Sequence Number: 1
• Product Code: NPT
• 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,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 10418
• Device Catalogue Number: 10418
• Device Lot Number: 0025778294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 92630745-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 81 YR