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

Model Number	H749LVSUS270
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a lotus edge valve delivery system kink occurred.Procedure summary: a 27mm lotus edge valve system (lot: 0025743067) was selected for a transcatheter aortic valve replacement (tavr) procedure.During insertion, the lotus edge valve delivery system kinked as it was advanced over the transverse aortic arch.The lotus edge valve system was removed from the patient and a second 27mm lotus edge valve system (lot:0025743062) was inserted through the same introducer sheath over a safari2 guidewire.After crossing the native aortic annulus, stage one of valve deployment was positioned too high so a partial recapture was performed in accordance with the instructions for use (ifu).The second positioning attempt resulted in the valve being slightly distal, so the lotus edge valve was recaptured, repositioned and then released.During removal of the lotus edge valve delivery system as the device was coming around the aortic arch there was a significant drop in blood pressure.A pericardial effusion was noted and a pericardiocentesis was performed.The chest cavity was opened.It was observed the nosecone of the lotus edge delivery system had perforated the apex of the left ventricle with a 5mm hole.A kink was noted on the safari2 guidewire however the lotus edge valve delivery system moved freely on the guidewire.The patient died on the operating table.
Additional Manufacturer Narrative
H3 device eval by mfr: the lotus edge device was returned fully sheathed.A kink was visible on the outer curve 5cm proximal to the tip of the outer sheath.The valve was unsheathed, and the valve components were evaluated.No other issues were noted.Procedural angiographic media was provided to assist in the investigation and was reviewed by a boston scientific medical director.Media shows 45 series from a transcatheter aortic valve implantation procedure.A pigtail catheter is positioned in the non-coronary cusp (ncc) in series 2.As contrast is pumped it is observed that the three cusps appear to be aligned in the one plane.A kink is visible on the delivery system (ds) at the level of the tantalum marker in series 3 as it is advancing up the descending aorta, confirming the reported event.The kink is more pronounced at the aortic arch in series 4 and the system is promptly removed.The origin of the kink was not captured in the media provided.Five minutes later, in series 7, a second lotus edge has been introduced and crosses the aortic arch with the tantalum marker in the correct orientation.The valve is positioned, un-sheathed and locked whilst being visualized with the braid marker on the ncc side.A partial re-sheath is performed in series 18 and the valve is positioned slightly deeper and is locked into place.As the valve is being partially re-captured, the nosecone is pulled back, and when the valve is unsheathed the nosecone moves deeper into the left ventricle, indicative of sub-optimal guidewire management.In series 27 the valve is released in a suitable position with a visible waist.Post-release the safari2 guidewire (gw) appears to be kinked at the tip of the nosecone during removal.
Event or Problem Description
It was reported that a lotus edge valve delivery system kink occurred.Procedure summary: a 27mm lotus edge valve system (lot: 0025743067) was selected for a transcatheter aortic valve replacement (tavr) procedure.During insertion, the lotus edge valve delivery system kinked as it was advanced over the transverse aortic arch.The lotus edge valve system was removed from the patient and a second 27mm lotus edge valve system (lot:0025743062) was inserted through the same introducer sheath over a safari2 guidewire.After crossing the native aortic annulus, stage one of valve deployment was positioned too high so a partial recapture was performed in accordance with the instructions for use (ifu).The second positioning attempt resulted in the valve being slightly distal, so the lotus edge valve was recaptured, repositioned and then released.During removal of the lotus edge valve delivery system as the device was coming around the aortic arch there was a significant drop in blood pressure.A pericardial effusion was noted and a pericardiocentesis was performed.The chest cavity was opened.It was observed the nosecone of the lotus edge delivery system had perforated the apex of the left ventricle with a 5mm hole.A kink was noted on the safari2 guidewire however the lotus edge valve delivery system moved freely on the guidewire.The patient died on the operating table.

• 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: 10841626
• Report Number: 2134265-2020-15171
• Device Sequence Number: 11695623
• Product Code: NPT
• UDI-Device Identifier: 08714729960928
• UDI-Public: 08714729960928
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2020
• Device Model Number: H749LVSUS270
• Device Catalogue Number: H749LVSUS270
• Device Lot Number: 0025743067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 11/15/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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
• Patient Age: 86 YR