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

Model Number PB 10

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452); Unspecified Heart Problem (4454)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

Citation: lehner a et al.Intermediate outcomes of transcatheter pulmonary valve replacement with the edwards sapien 3 valve ¿ german experience.Expert rev med devices.2019 sep;16(9):829-834.Doi: 10.1080/17434440.2019.1653180.Epub 2019 aug 30.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 procedural and intermediate patient outcomes following transcatheter pulmonary valve replacement (tpvr) using a specific type of non-medtronic transcatheter valve.All data were retrospectively collected from seven centers between 2015 and 2017.The study population included 56 patients and was predominantly female with a mean age of 25 years and a mean weight of 59 kg.Of those, 16 patients were previously implanted with medtronic contegra valved conduits and an undisclosed number of patients were previously implanted with medtronic melody transcatheter pulmonary valves.No serial numbers were provided.Among all patients, adverse events included: tpvr (valve-in-conduit or valve-in-valve) due to pulmonary stenosis, pulmonary regurgitation, combination of both stenosis and regurgitation (gradient greater than or equal to 20 mmhg and moderate to severe regurgitation), or right ventricular dysfunction.In addition, conversion from tpvr to surgical pulmonary valve implantation was necessary in two cases.Based on the available information, medtronic product was associated with the adverse events.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: 11021063
• MDR Text Key: 221821797
• Report Number: 2025587-2020-03832
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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
• Date Manufacturer Received: 12/02/2020
• 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: 25 YR
• Patient Weight: 59