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

Model Number PB 10

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

Citation: gil-jaurena jm, et al.Hybrid procedures.Opening doors for surgeon and cardiologist close collaboration.Front pediatr.2021 jul 27;9:687909.Doi: 10.3389/(b)(4).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 outcomes of hybrid procedures for patients with congenital heart disease.All data was collected from a single between january 2013 and december 2020.Of the 71 patients included in the study population (patient demographics not disclosed), 6 underwent surgical implantation of a medtronic melody transcatheter pulmonary valve (pulmonary position = 2, mitral position = 2, tricuspid position = 1, sub-xyphoid approach = 1).No unique device identifier numbers were provided.Of the six melody patients, the authors noted one died of septicemia several days after the implant procedure, with a proper functioning valve.No correlation was made between the melody valve and the death.Of the six melody patients, adverse events included: one case of attempted valve-in-valve replacement for regurgitation two years after melody implant in the tricuspid position.The authors wrote, ¿the melody regurgitation was likely produced by adherence between one leaflet and the cage (valve frame)¿.No further details were given about this case.No additional adverse patient effects or product performance issues 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: 13338414
• MDR Text Key: 286565699
• Report Number: 2025587-2022-00162
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 01/11/2022
• 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; Hospitalization