MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number EVOLUTR-23

Device Problems Perivalvular Leak (1457); Migration (4003)

Patient Problems Insufficiency, Valvular (1926); Left Ventricular Dysfunction (1947); Mitral Regurgitation (1964); Pulmonary Edema (2020); Right Ventricular Dysfunction (2054); Tricuspid Regurgitation (2112); Heart Failure (2206); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

Citation: duncan a et al.Midterm degeneration of transcatheter heart valve device following valve-in-valve transcatheter aortic valve replacement requiring repeat transcatheter aortic valve replacement.Case (phila).2020 jun 12;4(4):291-298.Doi: 10.1016/j.Case.2020.04.008.Earliest date of publish used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a literature case report regarding an (b)(6)-year-old male patient with a history of surgical aortic valve replacement (savr) with a 27 mm non-medtronic surgical aortic valve, permanent pacemaker implantation for complete heart block following savr, and one functional kidney following a road traffic accident as a child.Approximately thirteen years after savr, the patient presented with decompensated heart failure.Transesophageal echocardiography (tee) showed complete degeneration of thenon-coronary leaflet of the surgical aortic valve with severe transvalvular aortic incompetence (ai).The medical team decided to proceed with semi-emergent valve-in-valve transcatheter aortic valve replacement (viv-tavr) via left femoral access.A 26 mm medtronic evolut r transcatheter valve (serial number not provided) was implanted inside the degenerated surgical aortic valve.Despite several attempts to achieve a supra-annular position, optimal positioning of the evolut r was difficult, and the valve was ultimately deployed in a suboptimal low position in the left ventricular outflow tract (lvot).Following deployment, the valve fully expanded and peri-procedural mild-moderate paravalvular leak (pvl) was noted.The patient¿s condition rapidly improved and was discharged home four days after viv-tavr.Discharge transthoracic echocardiography (tte) exhibited mild pvl.One year and six months after viv-tavr, the patient presented with decompensated heart failure.Upon examination, chest auscultation was consistent with severe ai and pulmonary edema.Urgent tee was performed, which revealed the evolut r was ¿low-lying¿ and detailed assessment confirmed the valve had migrated down the lvot by 5 mm since the viv-tavr procedure.The physician/author stated there was no evidence of neoleaflet fracture.Severe transvalvular ai and moderate posterior pvl were noted and concurrent tte showed a left ventricular ejection fraction of 30%, right ventricle impairment, moderate mitral and tricuspid regurgitation, and significant pulmonary hypertension (pulmonary arterial systolic pressure: 70 mm hg).Subsequently, the medical team decided to perform a tavr-in-tavr procedure with pre-planned cardiopulmonary bypass support.Coronary protection was achieved with the placement of a non-medtronic coronary wire and balloon in the left anterior descending coronary artery and was followed by implantation of a 26 mm non-medtronic transcatheter valve inside of the evolut r.Despite a good valve position, the non-medtronic transcatheter valve was constrained within the leaflets of the evolut r, so a post-implant balloon aortic valvuloplasty (bav) was performed with a 25 mm non-medtronic balloon.Following the bav, aortography showed no evidence of coronary obstruction or pvl.The patient¿s condition again rapidly improved and was discharged home eight days after tavr-in-tavr.Discharge tte exhibited no pvl, reduced mitral and tricuspid regurgitation, and decreased pulmonary hypertension (pulmonary arterial systolic pressure: 50 mm hg).No additional adverse patient effects or product performance issues were reported.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10610427
• MDR Text Key: 209348533
• Report Number: 2025587-2020-02980
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: EVOLUTR-23
• Device Catalogue Number: EVOLUTR-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/30/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR