MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number EVPROPLUS-26US

Device Problems Calcified (1077); Gradient Increase (1270); Perivalvular Leak (1457); Activation Failure (3270); Patient Device Interaction Problem (4001); Thickening of Material (4056); Central Regurgitation (4068)

Patient Problems Calcium Deposits/Calcification (1758); Fatigue (1849); Dizziness (2194); Thrombosis/Thrombus (4440); Valvular Insufficiency/ Regurgitation (4449)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id {d-evprop2329us}; product lot/serial number {(b)(6)}; product type: {delivery catheter system (dcs)}; implant date {na}; explant date {na} product id {l-evprop2329us}; product lot/serial number {(b)(6)}; product type: {compression loading system (cls)}; implant date {na}; explant date {na} images were submitted to medtronic for review.The excerpt of the image subject matter expert (sme) review included intra procedural fluoroscopic images of the index procedure were provided for review.There was evidence of at least one recapture.The valve was deployed at a depth of approximately 1 millimeter (mm) at the non-coronary cusp.The valve appeared to be slightly under expanded at the inflow; however, there is no evidence of significant paravalvular leak (pvl); thus, a post dilatation was not performed.Transthoracic echocardiogram (tte) images reviewed from 2021-november-24.Evolut implant depth appeared shallow.Posterior mitral valve leaflet was calcified with restricted motion.No pvl or aortic insufficiency (ai) were noted.Aortic valve (av) mean pressure gradient was measured 8 millimeters of mercury (mmhg).Mild tricuspid regurgitation was present.Ejection fraction was about 60-65%.Tte images provided from 2022-january-04 included suboptimal image quality.Anterior mitral valve leaflet tip appeared calcified.No av changes noted.Ejection fraction was about 60-65%.Tte images provided from 2022-december-13.Mild central ai, mild mitral regurgitation and trace to mild tricuspid regurgitation were observed.Possible calcification of prosthetic valve leaflets seen.Av mean pressure gradient measured 18 mmhg.Ejection fraction was about 60-65%.Tte images provided from 2023-october-30 showed mild central ai.Av mean pressure gradient measured 33 mmhg, taken from the right sternal border.Ejection fraction was about 60-65%.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the depth was 1 mm on the non-coro nary cusp and 3 mm on the left coronary cusp.The mean gradient was 10 mmhg upon the time of discharge, and the patient was prescribed an antiplatelet medication.Approximately two years and one month following valve implant, the patient was experiencing dizziness.An echocardiogram was performed and revealed increased gradients of 50 mmhg for the peak gradient and a mean gradient of 26 mmhg.A computed tomography angiography was performed and confirmed thrombosis with hypoattenuated leaflet thickening measuring up to 6.5mm at the base on two out of three valve leaflets, along with severely restricted mobility of the leaflets.The leaflets were noted to be at the level of the sinotubular junction, which indicated a higher position of the valve.Additionally, mitral annular and subvalvular calcification was noted.An anticoagulant medication was initiated.A repeat transthoracic echocardiogram was performed six weeks later and revealed improvements in the valve gradients measuring at a peak gradient of 17 mmhg and a mean gradient of 10 mmhg.No adverse patient effects were reported.Additional information was received that during the implant of this transcatheter bioprosthetic valve the valve was recaptured one time due to a high position.There was nothing in regards to the patient¿s anatomy in regards to the high position.Rather, the physician¿s preference for optimal delivery.Ultimately, the valve was then deployed again and successfully implanted.Following the valve implant, an echocardiogram identified trace paravalvular leak (pvl).Treatment was not reported.Trace pvl was present approximately one year and one month later.No treatment reported.No adverse patient effects were reported.Approximately 1 year and 2 months following the valve implant, a routine diagnostic transthoracic echocardiogram (tte) via the primary cardiologist identified worsening aortic regurgitation.This was also reported as possible moderate unspecified valvular regurgitation.However, the implant physician¿s review assessed the pvl as no more than mild.There was report that the tte had been performed where protocol specific image acquisition may be questioned.It was then further reported that likely the regurgitation was no more than mild but a repeat tte in the valve center would be needed in 30 days.The patient self reported as feeling ¿great¿ but more tired recently.Approximately thirty days later, a repeat tte was performed and showed "great" valve function with trace pvl.No treatment has occurred and is not planned, not required.No adverse patient effects were reported.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information received noted the physician indicated that the thrombosis event was possibly related to the valve implant procedure in addition to being causal related to the valve itself.

• Brand Name: EVOLUT PRO PLUS VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19016511
• MDR Text Key: 339081947
• Report Number: 2025587-2024-02034
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000211110
• UDI-Public: 00763000211110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Model Number: EVPROPLUS-26US
• Device Catalogue Number: EVPROPLUS-26US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/08/2024
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 82 KG