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

Model Number 10418

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Arrhythmia (1721); Bradycardia (1751); Complete Heart Block (2627)

Event Date 09/29/2020

Event Type  Injury  

Event Description

(b)(6) study.It was reported that left bundle branch block (lbbb), 1st degree atrioventricular (av) block, right bundle branch (rbbb) and left anterior fascicular block occurred.The patient was enrolled into the (b)(6) study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was not on a prior regimen of aspirin or other antiplatelet medications.A loading dose of 324 mg of aspirin was given the day of the procedure.An isleeve introducer was placed and the aortic valve was treated with deployment of a 23 mm lotus edge valve.On the same day, post index procedure, the patient developed intermittent lbbb.One (1) day post index procedure, the patient developed intermittent first degree av block.No diagnostic procedure or action was taken to treat the events.Two (2) days post index procedure, the patient was discharged on other anticoagulant medication.Four (4) days post index procedure, the patient developed intermittent rbbb and intermittent left anterior fascicular block.No diagnostic procedure or action was taken to treat the events.At the time of reporting, the events was considered recovering/ resolving.

Event Description

Reprise iv study: it was reported that left bundle branch block (lbbb), 1st degree atrioventricular (av) block, right bundle branch (rbbb) and left anterior fascicular block occurred.The patient was enrolled into the reprise iv study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was not on a prior regimen of aspirin or other antiplatelet medications.A loading dose of 324 mg of aspirin was given the day of the procedure.An isleeve introducer was placed and the aortic valve was treated with deployment of a 23 mm lotus edge valve.On the same day, post index procedure, the patient developed intermittent lbbb.One (1) day post index procedure, the patient developed intermittent first degree av block.No diagnostic procedure or action was taken to treat the events.Two (2) days post index procedure, the patient was discharged on other anticoagulant medication.Four (4) days post index procedure, the patient developed intermittent rbbb and intermittent left anterior fascicular block.No diagnostic procedure or action was taken to treat the events.At the time of reporting, the events was considered recovering/ resolving.It was further reported that in october 2020, seven days post index procedure the patient was diagnosed with complete heart block, bilateral bundle branch block and accelerated junctional rhythm.The patient was recommended for an office visit for further evaluation of abnormal cardiac rhythms.Fifteen days post index procedure, the patient was hospitalized for further evaluation.Electrophysiology recommended implantation of new permanent pacemaker.On the same date, the patient was successfully implanted with a dual chamber permanent pacemaker (boston scientific accolade mri dr).The following day, the patient was discharged home on other anticoagulant.

Manufacturer Narrative

B5 describe event or problem - updated/corrected b7 other relevant history - updated h6 patient codes - updated.

Event Description

Reprise iv study it was reported that left bundle branch block (lbbb), 1st degree atrioventricular (av) block, right bundle branch (rbbb) and left anterior fascicular block occurred.The patient was enrolled into the reprise iv study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was not on a prior regimen of aspirin or other antiplatelet medications.A loading dose of 324 mg of aspirin was given the day of the procedure.An isleeve introducer was placed and the aortic valve was treated with deployment of a 23 mm lotus edge valve.On the same day, post index procedure, the patient developed intermittent lbbb.One (1) day post index procedure, the patient developed intermittent first degree av block.No diagnostic procedure or action was taken to treat the events.Two (2) days post index procedure, the patient was discharged on other anticoagulant medication.Four (4) days post index procedure, the patient developed intermittent rbbb and intermittent left anterior fascicular block.No diagnostic procedure or action was taken to treat the events.At the time of reporting, the events was considered recovering/ resolving.It was further reported that in (b)(6) 2020 seven days post index procedure the patient was diagnosed with complete heart block, bilateral bundle branch block and accelerated junctional rhythm.The patient was recommended for an office visit for further evaluation of abnormal cardiac rhythms.Fifteen days post index procedure, the patient was hospitalized for further evaluation.Electrophysiology recommended implantation of new permanent pacemaker.On the same date, the patient was successfully implanted with a dual chamber permanent pacemaker (boston scientific accolade mri dr).The following day, the patient was discharged home on other anticoagulant.It was further reported that the (b)(6) 2020 events started six (6) days post index procedure, not seven as previously reported.The patient was hospitalized fourteen days post index procedure, not fifteen days as previously reported.The subject tolerated the pacemaker implant procedure well.Chest xray revealed stable lead position.

• Brand Name: LOTUS EDGE VALVE SYSTEM
• Type of Device: LOTUS EDGE TM VALVE SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10667352
• MDR Text Key: 211048267
• Report Number: 2134265-2020-13900
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P180029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2020
• Device Model Number: 10418
• Device Catalogue Number: 10418
• Device Lot Number: 0025319509
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Removal/Correction Number: 92630745-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 87 YR