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

Model Number	H749LVSUS230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Stroke/CVA (1770); Complete Heart Block (2627)
Date of Event	03/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that complete heart block and stroke occurred.Prior to valve implant, heparin was administered and an act of greater than 250 was achieved.After the successful deployment of the lotus edge valve, the patient developed complete heart block.The patient received a permanent pacemaker(ppm) after the conclusion of the valve implant and was recovering in the icu.Three days post implant, the patient had a stroke of the posterior basal while still in the hospital.The patient was started on coumadin following the stroke.The patients symptoms of dizzy and confused resolved and has since been discharged home and is undergoing rehab therapy.
Additional Manufacturer Narrative
B5: describe event or problem: updated.H6: patient codes: updated.
Event or Problem Description
It was reported that complete heart block and stroke occurred.Prior to valve implant, heparin was administered and an act of greater than 250 was achieved.After the successful deployment of the lotus edge valve, the patient developed complete heart block.The patient received a permanent pacemaker(ppm) after the conclusion of the valve implant and was recovering in the icu.Three days post implant, the patient had a stroke of the posterior basal while still in the hospital.The patient was started on coumadin following the stroke.The patients symptoms of dizzy and confused resolved and has since been discharged home and is undergoing rehab therapy.It was further reported that post procedure, the patient developed aortic stenosis.

• 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: 9993099
• Report Number: 2134265-2020-05227
• Device Sequence Number: 3836675
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P180029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2020
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0024359138
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 12/01/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR