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

Model Number PB 10

Device Problems Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Endocarditis (1834); Pulmonary Valve Stenosis (2024); Regurgitation, Valvular (2335)

Event Date 10/12/2018

Event Type  Injury  

Manufacturer Narrative

Citation: cools b et al.Up to 11 years of experience with the melody valved stent in the right ventricular outflow tract.Eurointervention.2018 oct 12;14(9):e988-e994.Doi: 10.4244/eij-d-18-00054.Earliest date of publish used for event date.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 the 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 via literature regarding the reported observations from 11 years of follow-up data after melody valve implantation in the pulmonary position.All data were collected from a single center between 2006 and 2017.The study population included 185 patients (predominantly male; mean age 19 years; mean weight 51.5 kg), all of which were implanted with a medtronic melody bioprosthetic valve (18, 20, and 22 mm prosthesis sizes were used), 23 were previously implanted with a medtronic contegra conduit, 1 was previously implanted with a medtronic hancock conduit, and 3 were previously implanted with a medtronic freestyle bioprosthetic valve.No serial numbers were provided.Among all patients, 3 deaths occurred.The physician/author noted that none of the deaths were related to the valve or the procedure.Based on the available information, medtronic product did not cause or contribute to these deaths.Among all contegra, hancock, and freestyle patients, adverse events included: pulmonary stenosis, pulmonary regurgitation, or a combination of both requiring percutaneous pulmonary valve implantation (melody valve placed inside degenerated bioprosthesis).Based on the available information, medtronic product may have caused or contributed to these adverse events.Among all melody patients, adverse events included: valve explant due to coronary compression (1 case), endocarditis (6 cases), and progressive sub-valvular pulmonary stenosis (1 case), redo percutaneous pulmonary valve implantation due to stenosis after endocarditis (3 cases) or conduit stenosis ¿valve wall thickening¿ 10 years after initial implant (1 case).Other adverse events included: moderate pulmonary regurgitation and increased gradients (unspecified number of cases).Based on the available information, medtronic product may have caused or contributed to these adverse events.Among all melody patients, device malfunctions included: type i stent fractures observed at a mean of 4.2 years after implant (14 cases).No interventions were reported as a consequence of these fractures.Additionally, a type iii stent fracture was observed 5 years after initial implant requiring redo percutaneous pulmonary valve implantation (1 case).Based on the available information, these malfunctions may have been attributed to medtronic product.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: 8271730
• MDR Text Key: 133891799
• Report Number: 2025587-2019-00286
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: H080002
• 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: 01/23/2019

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: 01/02/2019
• Initial Date FDA Received: 01/23/2019
• 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: 19 YR
• Patient Weight: 52