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

Model Number PB 10

Device Problem Material Deformation (2976)

Patient Problems Atrial Flutter (1730); Dyspnea (1816); Pulmonary Valve Stenosis (2024); Heart Failure/Congestive Heart Failure (4446); Pulmonary Valve Insufficiency/ Regurgitation (4452); Respiratory Insufficiency (4462); Swelling/ Edema (4577)

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

Citation: kuc m et al. Successful pulmonary homograft re-implantation after previous surgical and percutaneous interventions. Kardiologia polska. 2018 february; 76(2):471. Doi: 10. 5603/kp. 2018. 0042. Published online: february 16, 2018. 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 male patient with a medical history of tetralogy of fallot with absent pulmonary valve requiring primary repair (at (b)(6) years of age) and later underwent surgical allograft repair due to allograft stenosis (at (b)(6) years of age). Seven years later (at (b)(6) years of age), due to recurrence of pulmonary allograft stenosis, the patient underwent transcatheter pulmonary valve implantation with a medtronic melody (serial number not provided). After the procedure, a right ventricular outflow tract (rvot) peak gradient of 18 mmhg was observed. One-week after melody implant, transthoracic echocardiography (tte) was performed and revealed a gradient of 76/36 mmhg. Two months after melody implant, the valve was expanded with a 22-mm balloon. Following the balloon dilation, the gradient was 35 mmhg, and subsequent tte showed a rvot gradient of 78/44 mmhg. Recurrent stent recoil was diagnosed. The patient was referred to surgery, but did not give consent. Six years after melody implant (at (b)(6) years of age), the patient presented with heart failure and paroxysmal atrial flutter, which impaired cardiac function causing dyspnea at rest and peripheral edema. Tte revealed pulmonary valve stenosis with peak/mean gradient of 130/75 mmhg and small pulmonary valve insufficiency. Cardiac magnetic resonance imaging exhibited large dysfunctional right heart chambers. Computed tomography scan showed stenosis of the pulmonary artery close to the bifurcation and damaged melody valve leaflets. Subsequently, the melody valve and pulmonary allograft were surgically explanted. A 25 mm pulmonary allograft was implanted using root-replacement technique. In the post-operative period, the patient endured right heart insufficiency, which was treated with diuretics. Tte confirmed good allograft function, which was reflected by a peak gradient of 16 mmhg. The patient was discharged 13 days after surgery in good condition without peripheral edema. 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 10945507
• MDR Text Key: 219503669
• Report Number: 2025587-2020-03680
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/04/2020 Patient Sequence Number: 1