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

Model Number	H749LVSUS250
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the delivery system kinked.The patient had severe abdominal aortic calcification.Access was gained through a right transfemoral approach.A 25mm lotus edge valve (lot 25699511) was advanced through and past the tip of the isleeve introducer approximately 10mm.An aortic dissection near the distal end of the isleeve introducer was observed.Calcification was present in the area of the dissection; the dissection was believed to be as a result of the isleeve sheath near the calcification.The lotus edge valve delivery system and isleeve introducer were removed without difficulty.The lotus edge valve (lot 25699511) had kinks approximately 1 inch from the tip and 3-4 inches from the tip.The isleeve introducer was appropriately expanded and also had a kink.An angiogram was taken and confirmed the dissection.The abdominal aorta was repaired with a graft.After the repair, a new isleeve introducer was advanced through the graft successfully.A new 25mm lotus edge valve was implanted successfully.Later that day, the patient died.The cause of death is believed to be a result of the abdominal aorta dissection caused by the introducer sheath.
Additional Manufacturer Narrative
H3: device eval by manufacturer: a 25mm lotus edge valve delivery system was returned to boston scientific and analyzed by a bsc quality engineer.The device returned sheathed and without the sterilization bottle.The outer sheath (os) was kinked on the outer curvature of the catheter, 1cm and 5cm proximal to the distal end of the os.The nosecone was correctly seated.The valve was unsheathed without issues and the kinks released slightly.The valve was re-sheathed without issue.The condition of the returned device is consistent with the reported event, the kinked delivery system was confirmed.
Event or Problem Description
It was reported that the delivery system kinked.The patient had severe abdominal aortic calcification.Access was gained through a right transfemoral approach.A 25mm lotus edge valve (lot 25699511) was advanced through and past the tip of the isleeve introducer approximately 10mm.An aortic dissection near the distal end of the isleeve introducer was observed.Calcification was present in the area of the dissection; the dissection was believed to be as a result of the isleeve sheath near the calcification.The lotus edge valve delivery system and isleeve introducer were removed without difficulty.The lotus edge valve (lot 25699511) had kinks approximately 1 inch from the tip and 3-4 inches from the tip.The isleeve introducer was appropriately expanded and also had a kink.An angiogram was taken and confirmed the dissection.The abdominal aorta was repaired with a graft.After the repair, a new isleeve introducer was advanced through the graft successfully.A new 25mm lotus edge valve was implanted successfully.Later that day, the patient died.The cause of death is believed to be a result of the abdominal aorta dissection caused by the introducer sheath.

• 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: 10546691
• Report Number: 2134265-2020-12326
• Device Sequence Number: 11547068
• Product Code: NPT
• UDI-Device Identifier: 08714729960911
• UDI-Public: 08714729960911
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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: 11/03/2020
• Device Model Number: H749LVSUS250
• Device Catalogue Number: H749LVSUS250
• Device Lot Number: 0025699511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/08/2020
• Patient Sequence Number: 1
• Patient Age: 79 YR