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

Model Number	H749LVSUS270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Renal Failure (2041)
Date of Event	09/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported arrhythmia occurred.The patient was selected for a 27mm lotus edge valve implant to treat severe aortic stenosis.During deployment, a widening of the qrs complex was observed.After the 27mm lotus edge valve was successfully implanted, the physicians elected to leave the temporary pacemaker in.The patient appeared to be intermittently dependent on the temporary pacemaker.Three (3) days post index procedure, a permanent pacemaker was implanted to treat the new left bundle branch block.There were no further consequences.
Event or Problem Description
It was reported arrhythmia occurred.The patient was selected for a 27mm lotus edge valve implant to treat severe aortic stenosis.During deployment, a widening of the qrs complex was observed.After the 27mm lotus edge valve was successfully implanted, the physicians elected to leave the temporary pacemaker in.The patient appeared to be intermittently dependent on the temporary pacemaker, so three days post index procedure, a permanent pacemaker was implanted to treat the new left bundle branch block.There were no further consequences.It was further reported that in (b)(6) 2020, the patient had a new requirement for dialysis.
Additional Manufacturer Narrative
B5 describe event or problem - updated.H6 patient codes - updated.H6 impact codes - updated.

• 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: 10615237
• Report Number: 2134265-2020-13343
• Device Sequence Number: 11514232
• Product Code: NPT
• UDI-Device Identifier: 08714729960928
• UDI-Public: 08714729960928
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P180029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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: 10/01/2020
• Device Model Number: H749LVSUS270
• Device Catalogue Number: H749LVSUS270
• Device Lot Number: 0025766016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 02/26/2021
• 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: 82 YR