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 Aortic Insufficiency (1715); Congestive Heart Failure (1783); Death (1802); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 08/11/2020

Event Type  Death  

Event Description

(b)(6) study.It was reported that valve thrombosis, congestive heart failure (chf), myocardial infarction (mi) and death 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 on a prior regimen of aspirin and other antiplatelet medications.A lotus introducer was placed and the aortic valve was treated with balloon valvuloplasty (bav).No conduction disturbances developed post bav.The aortic valve was treated with deployment of a 27 mm lotus edge valve.Successful repositioning of the 27mm lotus edge valve involved complete and partial re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).Seven days post index procedure, the patient was discharged on aspirin and clopidogrel.160 days post index procedure, echocardiogram and lab tests revealed prosthetic aortic valve stenosis/ thrombus and chf.Cardiac enzyme (troponin) was elevated consistent with protocol definition of mi.Echo revealed increased gradient suggesting bio-prosthetic obstruction.Aortic valve mean gradient was 34 mmhg, av pk grad 56 mmhg, av vmax 3.74 m/s suggesting thrombosis of valve.The events were treated medically and resulted in prolongation of hospitalization.Angiogram and angiography without revascularization were performed.The following day, 161 days post index procedure, the patient died.

Manufacturer Narrative

Describe event or problem: updated.Relevant tests/laboratory data: updated.Patient codes: updated.

Event Description

Reprise iv study: it was reported that valve thrombosis, congestive heart failure (chf), myocardial infarction (mi) and death 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 on a prior regimen of aspirin and other antiplatelet medications.A lotus introducer was placed and the aortic valve was treated with balloon valvuloplasty (bav).No conduction disturbances developed post bav.The aortic valve was treated with deployment of a 27 mm lotus edge valve.Successful repositioning of the 27mm lotus edge valve involved complete and partial re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).Seven days post index procedure, the patient was discharged on aspirin and clopidogrel.160 days post index procedure, echocardiogram and lab tests revealed prosthetic aortic valve stenosis/ thrombus and chf.Cardiac enzyme (troponin) was elevated consistent with protocol definition of mi.Echo revealed increased gradient suggesting bio-prosthetic obstruction.Aortic valve mean gradient was 34 mmhg, av pk grad 56 mmhg, av vmax 3.74 m/s suggesting thrombosis of valve.The events were treated medically and resulted in prolongation of hospitalization.Angiogram and angiography without revascularization were performed.The following day, 161 days post index procedure, the patient died.It was further reported that in august 2020, 160 days post index procedure, the patient presented emergently with complaints of sharp chest pain which radiated to the left arm and lower led edema persistent for two days.Upon admission, physical examination revealed jugular vein distention and lower leg edema.Heart rate and rhythm and breathing sounds were normal.On the same day, echocardiogram revealed high mean aortic gradient and low left ventricular ejection fraction which per source was due to prosthetic aortic valve stenosis/ thrombus.Chest x-ray revealed cardiomegaly with mild pulmonary edema.Further lab tests indicated elevated probnp value=558.The subject was diagnosed with congestive heart failure (chf).The following day, the subject's condition was noted to be have worsened with worsening chest pain and hypotension; subject was urgently taken to the cath lab.In the cath lab, the subject's grafts were noted to be patent, but the aortic valve was noted to be severely stenosed.The subject however went into a cardiac arrest.Code blue was called, and return of spontaneous circulation (rosc) was achieved quickly and the patient started talking soon afterwards; intubation removed.However, shortly the subject experienced a second pulseless electrical activity (pea) arrest, and was intubated again.However, resuscitation attempts failed.The primary cause of death was cardiopulmonary arrest.

• 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: 10689999
• MDR Text Key: 211664154
• Report Number: 2134265-2020-14025
• 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
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2020
• Device Model Number: 10418
• Device Catalogue Number: 10418
• Device Lot Number: 0024802252
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Removal/Correction Number: 92630745-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 74 YR