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

Model Number PB 10

Device Problem Biocompatibility (2886)

Patient Problem Fever (1858)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

Citation: sheth k., et al.Early multicenter experience of melody valve implantation in india.Ann pediatr cardiol.Jul-sep 2021;14(3):302-309.Doi: 10.4103/apc.Apc_73_21.Epub 2021 aug 26.Pmid: 34667400 earliest date of publish used for date of event.Medtronic products referenced: contegra (pma# h020003, product code: mwh); melody (pma# p140017, product code: npv).Earliest approved product used for product code and pma#.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 an indian multicenter experience with percutaneous pulmonary valve implantation (ppvi) for pediatric patients with right ventricular outflow tract (rvot) dysfunction.All data were collected from four medical centers starting january 2018.The study population included 15 patients (predominantly male, mean age 23 years, weight range 26-81 kg (median weight 53.5 kg), all of whom were implanted with medtronic melody bioprosthetic valves using the ensemble delivery system (unique device identifier numbers not provided).Three patients had previously been implanted with medtronic contegra valved conduits (unique device identifier numbers not provided).Among all contegra patients, adverse events included: degenerated valves leading to right ventricular dysfunction, elevated transvalvular gradients and severe pulmonary regurgitation/stenosis.Based on the available information medtronic product was directly associated with the adverse events.Among all melody patients, one patient experienced four days of post-ppvi fever attributed to glutaraldehyde elution from the melody valve, which was treated with non-steroid anti-inflammatory medication.Based on the available information medtronic product was directly associated with the adverse event.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: 12753894
• MDR Text Key: 280218151
• Report Number: 2025587-2021-03345
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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: 10/11/2021
• 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: 23 YR
• Patient Weight: 54