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

Model Number PB 10

Device Problems Fracture (1260); Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Endocarditis (1834); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

Citation: sadeghi s et al. Risk factors for infective endocarditis following transcatheter pulmonary valve replacement in patients with congenital heart disease. Catheter cardiovasc interv. 2019 oct 1;94(4):625-635. Doi: 10. 1002/ccd. 28474. Epub 2019 aug 30. 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 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 risk factors for infective endocarditis in patients who underwent transcatheter pulmonary valve replacement (tpvr). All data were retrospectively collected from a single center between october 2010 and october 2017. The study population included 235 patients and was predominantly male with a mean age of 22 years and a mean weight of 63 kg. Of those, 183 were implanted with medtronic melody transcatheter valves; 3 were previously implanted with medtronic hancock valved conduits; and 2 were previously implanted with medtronic mosaic surgical valves. No serial numbers were provided. It was reported that the median duration from transcatheter valve implant to onset of endocarditis was 3. 3 years (range 2 to 7. 2 years). Among all melody patients, 2 deaths were reported. The causes of death were due to septic shock (1) and cardiac arrest secondary to heart failure 1. 5 years after recurrent episode of endocarditis (1). Based on the available information, medtronic product was not directly associated with the deaths. Among all melody patients, adverse events included: severe pulmonary stenosis and/or stent fracture that required redo tpvr, bacterial endocarditis, surgical explant and replacement of the valve due to fungal endocarditis, valvular mobile mass and/or vegetations due to bacterial or fungal endocarditis, extracorporeal membrane oxygenation support, moderate-severe pulmonary regurgitation, and high peak/mean residual gradients. Based on the available information, medtronic product was associated with the adverse events. Among all hancock and mosaic patients, adverse events included: transcatheter valve-in-valve implantation. The reason for valve-in- valve implantation was not reported. Other adverse events observed: moderate-severe pulmonary regurgitation and high peak/mean gradients. 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9526863
• MDR Text Key: 187046938
• Report Number: 2025587-2019-03900
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• 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: 12/04/2019
• 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: 12/27/2019 Patient Sequence Number: 1