MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number PB 10

Device Problems Perivalvular Leak (1457); Device Slipped (1584)

Patient Problems Dyspnea (1816); Insufficiency, Valvular (1926); Heart Failure (2206); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

Citation: basman c et al.Transcatheter aortic valve-in-valve-in-valve implantation with three-dimensional printing guidance: a case report.J card surg.2020 jul;35(7):1676-1680.Doi: 10.1111/jocs.14614.Epub 2020 may 5.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 a (b)(6)-year-old morbidly obese male patient with a history of hypertension, paroxysmal atrial fibrillation on warfarin, obstructive sleep apnea, pulmonary embolism, nonischemic cardiomyopathy (left ventricular ejection fraction of 30%) status post resynchronization therapy and implantation of automated internal cardiac defibrillator, aortic aneurysm, and bicuspid aortic valve status following four surgical aortic valve replacement procedures.Due to severe insufficiency and moderate stenosis of the non-medtronic surgical aortic valve, the patient underwent transcatheter aortic valve-in-valve implantation with a medtronic melody transcatheter pulmonary valve (serial number not provided).Afterward, mild-moderate residual paravalvular regurgitation was noted, but the patient's clinical symptoms improved.Four years later, the patient presented with progressive dyspnea and new york heart association class iv heart failure.Transthoracic echocardiography and computed tomography angiography revealed severe valvular and paravalvular aortic incompetence along with a stable ascending aortic aneurysm.The melody valve leaflets were thickened with significant prolapse.The patient was deemed high risk for redo surgery and the decision was made to proceed with transcatheter valve-in-valve-in-valve implantation.Subsequently, a 29 mm medtronic corevalve (serial number not provided) was implanted inside the melody valve.A post-implant balloon aortic valvuloplasty (bav) was performed with a 24 mm non-medtronic balloon.Following the bav, transesophageal fusion imaging and root angiogram showed trivial paravalvular regurgitation.At one-month follow-up, the patient's dyspnea had resolved, and a transthoracic echocardiogram noted trivial paravalvular leak (pvl).Five years after the valve-in-valve-in-valve procedure, the patient was admitted for rapid atrial fibrillation and both transthoracic and transesophageal echocardiography exhibited trivial pvl.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY 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: 10589979
• MDR Text Key: 208747438
• Report Number: 2025587-2020-02935
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2020

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: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2020
• Initial Date FDA Received: 09/25/2020
• 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: 65 YR