MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LOTUS VALVE SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 10415

Device Problem Degraded (1153)

Patient Problems Aortic Insufficiency (1715); Thrombosis (2100)

Event Date 09/14/2020

Event Type  Injury  

Event Description

Reprise iii lotus valve study.It was reported that aortic valve deterioration and aortic gradient elevation occurred.Prior to the index procedure, heparin or another anticoagulant was given and the subject was on prior regimen of aspirin at the time of index procedure.The subject received a loading dose of 300 mg of clopidogrel.A lotus introducer sheath was placed and subsequent deployment of a 23 mm lotus valve was implanted successfully into the proper anatomical location.Post procedure event summary: 1861 days post index procedure, aortic valve deterioration was noted.No diagnostics were performed and no action was taken for the event.At the time of reporting the event was considered not recovered.

Event Description

Reprise iii lotus valve study it was reported that aortic valve deterioration and aortic gradient elevation occurred.Procedure summary: prior to the index procedure, heparin or another anticoagulant was given and the subject was on prior regimen of aspirin at the time of index procedure.The subject received a loading dose of 300 mg of clopidogrel.A lotus introducer sheath was placed and subsequent deployment of a 23 mm lotus valve was implanted successfully into the proper anatomical location.Post procedure event summary: 1861 days post index procedure, aortic valve deterioration was noted.No diagnostics were performed and no action was taken for the event.At the time of reporting the event was considered not recovered.It was further reported that during the index procedure, a lotus introducer sheath(lis) was placed and then the native aortic valve was treated with balloon valvuloplasty, according to the instructions for use(ifu).The subject was discharged on aspirin and clopidogrel the day following the procedure.1861 days post index procedure, a computerized tomography scan was used as a diagnostic test.

Manufacturer Narrative

B2 outcomes attributed to adverse event - updated.B5: describe event or problem: updated / corrected.B6: relevant tests / laboratory data: updated.

Event Description

Reprise iii lotus valve study.It was reported that aortic valve deterioration and aortic gradient elevation occurred.Procedure summary: prior to the index procedure, heparin or another anticoagulant was given and the subject was on prior regimen of aspirin at the time of index procedure.The subject received a loading dose of 300 mg of clopidogrel.A lotus introducer sheath was placed and subsequent deployment of a 23 mm lotus valve was implanted successfully into the proper anatomical location.Post procedure event summary: 1861 days post index procedure, aortic valve deterioration was noted.No diagnostics were performed and no action was taken for the event.At the time of reporting the event was considered not recovered.It was further reported that during the index procedure, a lotus introducer sheath(lis) was placed and then the native aortic valve was treated with balloon valvuloplasty, according to the instructions for use(ifu).The subject was discharged on aspirin and clopidogrel the day following the procedure.1861 days post index procedure, a computerized tomography scan was used as a diagnostic test.It was further reported that on (b)(6) 2020, 1861 days post index procedure, transthoracic echocardiogram(tte) noted that aortic gradients were consistent with prosthetic obstruction.On (b)(6) 2020, cardiovascular computed tomography angiography(cv cta) 4d scan revealed, the presence of the bioprosthetic aortic valve (lotus valve).There was evidence of large burden of hypo-attenuating leaflet thrombus predominantly involving the non and left coronary cusps with minimal involvement of the right cusp.There was a significant restriction of leaflet motion.Small retrograde dissection flap in the anterior wall of the ascending aorta likely catheter related which was not present on baseline ct was noted.2mg of coumadin was initiated to treat the event, not as previously reported as no action was taken to treat the event.On (b)(6) 2020, repeat tte revealed left ventricular ejection fraction of 55 %.Right ventricle is normal in size, systolic pressure and function.Prosthetic aortic valve is well seated with no valvular regurgitation, possible trivial paravalvular leak with peak gradient of 15/8 mm hg.Mitral annular calcification with mild to moderate regurgitation.Aortic root normal.Pericardium normal.

• Brand Name: LOTUS VALVE SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10627217
• MDR Text Key: 209804829
• Report Number: 2134265-2020-13613
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2016
• Device Model Number: 10415
• Device Catalogue Number: 10415
• Device Lot Number: 0010000673
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 87 YR