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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM; LOTUS EDGE TM VALVE SYSTEM
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BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM; LOTUS EDGE TM VALVE SYSTEM Back to Search Results
Model Number 10418
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Arrhythmia (1721); Dizziness (2194)
Event Date 11/09/2020
Event Type  Injury  
Event Description
Reprise iv study.It was reported that an arrhythmia 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 antiplatelet medications or aspirin.Loading doses of 325 mg of aspirin and 600 mg of clopidogrel were given the day of the procedure.An isleeve introducer was placed and the aortic valve was treated with balloon valvuloplasty and subsequent deployment of a 23 mm lotus edge valve.Post balloon valvuloplasty, new left bundle branch block was observed.Successful repositioning of the lotus edge valve involved partial re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).One day post index procedure, a permanent pacemaker was implanted.That day, the event was considered resolved and the patient was discharged.
 
Event Description
Reprise iv study.It was reported that an arrhythmia 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 antiplatelet medications or aspirin.Loading doses of 325 mg of aspirin and 600 mg of clopidogrel were given the day of the procedure.An isleeve introducer was placed and the aortic valve was treated with balloon valvuloplasty and subsequent deployment of a 23 mm lotus edge valve.Post balloon valvuloplasty, new left bundle branch block was observed.Successful repositioning of the lotus edge valve involved partial re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).One day post index procedure, a permanent pacemaker was implanted.That day, the event was considered resolved and the patient was discharged.It was further reported that on the same day, post index procedure, electrocardiogram (ecg) revealed normal sinus rhythm, lbbb and abnormal ecg.A temporary pacing wire was left in place for rhythm management and the patient was monitored under telemetry.Eventually, the patient's condition improved and the temporary pacing wire was removed.One day post index procedure, the patient has an episode of dizziness and syncope while ambulating.The patient was found collapsed and almost passed out.The patient was discharged on aspirin and clopidogrel.
 
Manufacturer Narrative
B5 describe event or problem - updated.B6 relevant tests/laboratory data - updated.H6 patient codes - updated.
 
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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 Key10945142
MDR Text Key219488520
Report Number2134265-2020-16794
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
PMA/PMN Number
P180029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Recall
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/07/2020
Device Model Number10418
Device Catalogue Number10418
Device Lot Number0025319278
Was Device Available for Evaluation? No
Date Manufacturer Received12/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number92630745-FA
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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