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

Model Number PB 10

Device Problems Perivalvular Leak (1457); Material Split, Cut or Torn (4008)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Insufficiency, Valvular (1926)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

Citation: sinha s, et al.Application of transcatheter valves for aortic valve replacement in pediatric patients: a case series.Catheter cardiovasc interv.2019 oct 14.Doi: 10.1002/ccd.28505.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 transcatheter aortic valve replacement (tavr) in a pediatric population with congenital heart diseases.All data were retrospectively collected from a single center between january 2012 and january 2018.The study population included seven patients (mean age 10 years, mean weight 34.8 kg), two of which were implanted with a medtronic melody bioprosthetic valve (no serial numbers provided).Among all medtronic melody patients, adverse events included: mild paravalvular leak and leaflet avulsion resulting in moderate-severe aortic regurgitation and/or stenosis which required transcatheter valve replacement.Based on the available information medtronic product was directly 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: 9532916
• MDR Text Key: 173251888
• Report Number: 2025587-2019-03921
• 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: Physician
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 12/05/2019
• 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): Life Threatening; Required Intervention
• Patient Age: 10 YR
• Patient Weight: 35