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 Code	Complete Heart Block (2627)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) study.It was reported that complete heart block (chb) occurred.The patient was enrolled into the (b)(6) study and the index procedure was performed that 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 aspirin was given.After heparin was given, and prior to the sentinel cerebral protection system being inserted, the activated clotting time as 285 sec.An introducer was placed into the right radial artery and the sentinel cerebral protection system was inserted and successfully deployed.A lotus introducer sheath was placed and the aortic valve was treated with deployment of a 27 mm lotus edge valve into the proper anatomical location.On the same day, post index procedure, the patient was diagnosed with recurrent chb.Hospitalization was prolonged as ventricular fibrillation and respiratory failure were also observed and treated with medically and with a cardioversion, but were not related to the lotus edge valve.A dual chamber icd was implanted and electro cardioversion was performed in response to the ventricular fibrillation and respiratory failure.Three days post index procedure, the patient was transferred to the medical/surgical ward with 325 mg of aspirin.Four days post index procedure, the patient was discharged to inpatient rehabilitation.

• 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: 10886730
• Report Number: 2134265-2020-16279
• Device Sequence Number: 14215244
• Product Code: NPT
• UDI-Device Identifier: 08714729960928
• UDI-Public: 08714729960928
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 11/23/2020

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: 10/30/2020
• Device Model Number: H749LVSUS270
• Device Catalogue Number: H749LVSUS270
• Device Lot Number: 0025760756
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 11/23/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR