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

Model Number PB 10

Device Problem Gradient Increase (1270)

Patient Problems Endocarditis (1834); High Blood Pressure/ Hypertension (1908); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)

Event Date 03/09/2018

Event Type  Injury  

Manufacturer Narrative

Citation: malekzadeh-milani s et al.French national survey on infective endocarditis and the melody valve in percutaneous pulmonary valve implantation.Arch cardiovasc dis.(b)(6) 2018.Pii: s1875-2136(18)30026-3.Doi: 10.1016/j.Acvd.2017.10.007.Earliest date of e-publish/publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.    if information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a french national survey on infective endocarditis and the melody valve in percutaneous pulmonary valve implantation. all data were collected from multiple centers between 2008 and 2016. the study population included 43 patients (predominantly male; mean age 26 years), 5 of which were initially implanted with medtronic hancock, 11 of which were initially implanted with medtronic contegra, and 43 of which were implanted with medtronic melody valves valve-in-valve (serial numbers not provided).  among all patients implanted with the hancock conduit, adverse events included: stenosis, regurgitation, and an increased gradient of 43 mmhg, requiring a valve-in-valve implant.Based on the available information, the stenosis, regurgitation, and increased gradient were attributed to medtronic product.Among all patients implanted with the contegra conduit, adverse events included: stenosis, regurgitation, and increased gradient of 43 mmhg, requiring a valve-in-valve implant.Endocarditis was also reported five years following the implant. based on the available information, the stenosis, regurgitation, and increased gradient were attributed to medtronic product.Among all patients implanted with the melody transcatheter pulmonary bioprosthetic valve (tpbv), adverse events included: endocarditis, pulmonary hypertension, increased gradient, pulmonary regurgitation, and right ventricular outflow tract (rvot) obstruction requiring a surgical or percutaneous intervention.No additional adverse patient effects 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: 7422842
• MDR Text Key: 105204464
• Report Number: 2025587-2018-00839
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P140017
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• 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: 04/09/2018
• 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: 26 YR