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

Model Number 10415

Device Problems Degraded (1153); Malposition of Device (2616)

Patient Problems Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Congestive Heart Failure (1783); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/29/2020

Event Type  Injury  

Event Description

(b)(6) study.It was reported that aortic valve stenosis and congestive heart failure occurred.Prior to the index procedure, heparin and another anticoagulants were given and the subject was on a prior regimen of aspirin at the time of index procedure.The subject received a loading dose of 81 mg aspirin.A lotus introducer sheath was placed and then the native aortic valve was treated with balloon valvuloplasty, according to the instructions for use(ifu).Next, subsequent deployment of a 23 mm lotus valve into the proper anatomical location was performed.Two days post index procedure, the subject was discharged on warfarin and clopidogrel.In (b)(6) 2020, the subject presented with closed displaced communicated fracture of the shaft of the femur.On the same day, knee replacement was done and the event was considered recovered/resolved.The subject was on coumadin and plavix for underlying conditions.Due to high international normalized ratio(inr) of 3.02, the subject was given vitamin k, anticoagulation and coumadin was replaced with heparin.On the same day, post knee surgery, orthopedic consultation recommended for surgery and possible revision arthroplasty, however the same was not performed due to heart condition and the subject was recommended for cardiac consultation.The following day, 1681 days post index procedure, the subject was transferred to another facility for cardiac consultation.The subject stated prolonged worsening short of breath and dyspnea with minimal exertion, orthopnea and weakness with limited physical activity.Physical examination revealed systolic murmur consistent with aortic stenosis and 2+ pitting edema.The subject was diagnosed with severe aortic stenosis.Computed tomography (ct) scan and echocardiogram were performed as a diagnostic procedure for the event.The event led to prolongation of hospitalization.On the same day, repeat transcatheter aortic valve replacement(tavr) procedure was performed, as a valve in valve procedure with a 26mm non-bsc valve to treat the stenosis.Post event echocardiogram revealed valve in valve aortic valve mean gradient of 19.8 mm hg, and no paravalvular leak.The event was considered recovered.

Manufacturer Narrative

B5: describe event or problem: updated.B6: relevant tests/laboratory data: updated.H6: patient codes: updated.B3 date of event: corrected from (b)(6) 2020 to (b)(6) 2020.

Event Description

Reprise iii study.It was reported that aortic valve stenosis and congestive heart failure occurred.Prior to the index procedure, heparin and another anticoagulants were given and the subject was on a prior regimen of aspirin at the time of index procedure.The subject received a loading dose of 81 mg aspirin.A lotus introducer sheath was placed and then the native aortic valve was treated with balloon valvuloplasty, according to the instructions for use(ifu).Next, subsequent deployment of a 23 mm lotus valve into the proper anatomical location was performed.Two days post index procedure, the subject was discharged on warfarin and clopidogrel.In (b)(6) 2020, the subject presented with closed displaced communicated fracture of the shaft of the femur.On the same day, knee replacement was done and the event was considered recovered/resolved.The subject was on coumadin and plavix for underlying conditions.Due to high international normalized ratio(inr) of 3.02, the subject was given vitamin k, anticoagulation and coumadin was replaced with heparin.On the same day, post knee surgery, orthopedic consultation recommended for surgery and possible revision arthroplasty, however the same was not performed due to heart condition and the subject was recommended for cardiac consultation.The following day, 1681 days post index procedure, the subject was transferred to another facility for cardiac consultation.The subject stated prolonged worsening short of breath and dyspnea with minimal exertion, orthopnea and weakness with limited physical activity.Physical examination revealed systolic murmur consistent with aortic stenosis and 2+ pitting edema.The subject was diagnosed with severe aortic stenosis.Computed tomography (ct) scan and echocardiogram were performed as a diagnostic procedure for the event.The event led to prolongation of hospitalization.On the same day, repeat transcatheter aortic valve replacement(tavr) procedure was performed, as a valve in valve procedure with a 26mm non-bsc valve to treat the stenosis.Post event echocardiogram revealed valve in valve aortic valve mean gradient of 19.8 mm hg, and no paravalvular leak.The event was considered recovered.It was further reported that on (b)(6) 2020, 1476 days post index procedure, transthoracic echocardiogram (tte) revealed mild concentric left ventricular hypertrophy, mitral annular calcification and moderate mitral stenosis, severe atrial enlargement, well seated bioprosthetic valve, severe aortic stenosis with increased mean gradient of 42 mm hg since (b)(6) 2019.The subject was diagnosed with severe aortic stenosis.

Event Description

Reprise iii study: it was reported that aortic valve stenosis and congestive heart failure occurred.Prior to the index procedure, heparin and another anticoagulants were given and the subject was on a prior regimen of aspirin at the time of index procedure.The subject received a loading dose of 81 mg aspirin.A lotus introducer sheath was placed and then the native aortic valve was treated with balloon valvuloplasty, according to the instructions for use(ifu).Next, subsequent deployment of a 23 mm lotus valve into the proper anatomical location was performed.Two days post index procedure, the subject was discharged on warfarin and clopidogrel.In (b)(6) 2020, the subject presented with closed displaced communicated fracture of the shaft of the femur.On the same day, knee replacement was done and the event was considered recovered/resolved.The subject was on coumadin and plavix for underlying conditions.Due to high international normalized ratio(inr) of 3.02, the subject was given vitamin k, anticoagulation and coumadin was replaced with heparin.On the same day, post knee surgery, orthopedic consultation recommended for surgery and possible revision arthroplasty, however the same was not performed due to heart condition and the subject was recommended for cardiac consultation.The following day, 1681 days post index procedure, the subject was transferred to another facility for cardiac consultation.The subject stated prolonged worsening short of breath and dyspnea with minimal exertion, orthopnea and weakness with limited physical activity.Physical examination revealed systolic murmur consistent with aortic stenosis and 2+ pitting edema.The subject was diagnosed with severe aortic stenosis.Computed tomography (ct) scan and echocardiogram were performed as a diagnostic procedure for the event.The event led to prolongation of hospitalization.On the same day, repeat transcatheter aortic valve replacement(tavr) procedure was performed, as a valve in valve procedure with a 26mm non-bsc valve to treat the stenosis.Post event echocardiogram revealed valve in valve aortic valve mean gradient of 19.8 mm hg, and no paravalvular leak.The event was considered recovered.It was further reported that on (b)(6) 2020, 1476 days post index procedure, transthoracic echocardiogram (tte) revealed mild concentric left ventricular hypertrophy, mitral annular calcification and moderate mitral stenosis, severe atrial enlargement, well seated bioprosthetic valve, severe aortic stenosis with increased mean gradient of 42 mm hg since (b)(6) 2019.The subject was diagnosed with severe aortic stenosis.It was further reported that in (b)(6) 2020, 1663 days post index procedure, the subject was diagnosed with potential tavr valve degeneration and recommended for valve-in-valve procedure.1678 days post index procedure, subject complaints of left knee pain status post ground-level fall presented to emergency department.Subject also states that along with pain, has an inability to bear weight as well as numbness and tingling in left lower extremity.The previously reported transfer to another hospital was also due to unclear anesthesia management because of cardiac disease.

Manufacturer Narrative

B5: describe event or problem: updated.B6: relevant tests/laboratory data: updated.H6: patient impact: updated.

• 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: 10553142
• MDR Text Key: 207513859
• Report Number: 2134265-2020-12362
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2016
• Device Model Number: 10415
• Device Catalogue Number: 10415
• Device Lot Number: 0018307649
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR