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); Myocardial Infarction (1969); Complete Heart Block (2627)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) study.It was reported that complete heart block (chb), left bundle branch block(lbbb), and myocardial infarction occurred.Procedure summary: prior to the index procedure, heparin or another anticoagulant was given and the subject was on a prior regimen of aspirin at the time of index procedure.The subject received loading doses of 325 mg aspirin and 600 mg of clopidogrel.An isleeve introducer sheath was placed then a 25 mm lotus edge valve (lot: 25319445) was inserted but not implanted and was retrieved due to small sizing.A second 27 mm lotus edge valve (lot: 25785357) was implanted successfully in the correct anatomical location.During the index procedure, post valve deployment the subject developed chb.Post procedure event summary: on the same day as the index procedure, event electrocardiogram (ecg) revealed prolonged pr interval, left bundle branch block, and probable acute infarct(myocardial infarction).The event led to prolongation of hospitalization.On the same day post index procedure, a new magnetic resonance imaging (mri) compatible non-bsc dual chamber permanent pacemaker was implanted successfully.Two days post index procedure, the event was considered recovered and the subject was discharged on aspirin.
Additional Manufacturer Narrative
B5: describe event or problem: updated.H6: patient codes: updated.
Event or Problem Description
Reprise iv study: it was reported that complete heart block (chb), left bundle branch block(lbbb), and myocardial infarction occurred.Procedure summary: prior to the index procedure, heparin or another anticoagulant was given and the subject was on a prior regimen of aspirin at the time of index procedure.The subject received loading doses of 325 mg aspirin and 600 mg of clopidogrel.An isleeve introducer sheath was placed then a 25 mm lotus edge valve (lot: 25319445) was inserted but not implanted and was retrieved due to small sizing.A second 27 mm lotus edge valve (lot: 25785357) was implanted successfully in the correct anatomical location.During the index procedure, post valve deployment the subject developed chb.Post procedure event summary: on the same day as the index procedure, event electrocardiogram (ecg) revealed prolonged pr interval, left bundle branch block, and probable acute infarct(myocardial infarction).The event led to prolongation of hospitalization.On the same day post index procedure, a new magnetic resonance imaging (mri) compatible non-bsc dual chamber permanent pacemaker was implanted successfully.Two days post index procedure, the event was considered recovered and the subject was discharged on aspirin.It was further reported that the previously reported acute myocardial infarction(mi) was not considered a mi.No mi symptoms were present.

• 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: 10609576
• Report Number: 2134265-2020-13464
• Device Sequence Number: 11463792
• Product Code: NPT
• UDI-Device Identifier: 08714729960928
• UDI-Public: 08714729960928
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 11/12/2020
• Device Model Number: H749LVSUS270
• Device Catalogue Number: H749LVSUS270
• Device Lot Number: 0025785357
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR