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

Model Number PB 10

Device Problem Gradient Increase (1270)

Patient Problems Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 07/09/2021

Event Type  Injury  

Manufacturer Narrative

Citation: o¿callaghan b, et al. Contrast-free percutaneous pulmonary valve replacement: a safe approach for valve-in-valve procedures. Advances in interventional cardiology. 2021 jun;17(2):200-209. Doi: 10. 5114/aic. 2021. 107500. Epub: 2021 jul 9. 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 article regarding the patient outcomes following contrast-free percutaneous pulmonary valve replacement (ppvi). The authors retrospectively collected ppvi data from the preceding two years (approximately 2018 to 2020) at a single center. The study population included 21 patients (predominantly female; median age 27 years; mean weight 69. 6 kg). One patient was previously implanted with a 27 mm medtronic mosaic bioprosthetic valve in the pulmonary position. Two patients were implanted with medtronic melody transcatheter pulmonary valves. Of these two patients, one was previously implanted with a 22 mm melody inside a pulmonary homograft, and the other patient underwent contrast-free implantation of an 18 mm melody within a 21 mm sorin mitroflow valve. No unique device identifier numbers were provided. The mosaic patient underwent ppvi (transcatheter valve-in-valve replacement) with an edwards sapien 3 bioprosthesis. The patient previously implanted with a 22 mm melody underwent ppvi (transcatheter valve-in-valve replacement) with an edwards sapien 3 bioprosthesis. The authors noted the mean time from bioprosthetic valve implantation to ppvi was 8. 5 years (range of 6 to 17 years) and the cause of valve dysfunction was isolated stenosis or mixed stenosis and regurgitation. Elevated pressure gradients were also observed before ppvi. No patient had more than trivial pulmonary incompetence after ppvi. No additional adverse patient effects or product performance issues associated with medtronic product were reported.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI
• 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: 12800336
• MDR Text Key: 280761079
• Report Number: 2025587-2021-03421
• 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: Literature,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• 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
• Date Manufacturer Received: 10/14/2021
• 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: 11/11/2021 Patient Sequence Number: 1