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

Model Number PB 10

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

Citation: kato a, et al.P1845 - mitral valve replacement using stented bovine jugular vein graft (melody valve) in infants and small children.Cardiology in the young ¿ world congress of pediatric cardiology and cardiac surgery.July 16-21, 2017.27(supp.4):s539.Doi:10.1017/s104795111700110x.Published online: 12 july 2017.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 abstract regarding mitral valve replacement using the melody valve in infants and small children.All data was retrospectively collected from a single center between 2014 and 2016.Prior to implant in the mitral valve, the authors modified the 22 mm melody valves by sewing a 3.5 mm goretex tube graft at the middle of the stent as a cuff and resecting one or three zigs to avoid left ventricular outflow tract (lvot) obstruction.The study population included five patients (median age 11 months, median weight 6.8 kg) who were all implanted with a medtronic melody transcatheter pulmonary valve in the mitral position.No unique device identifier numbers were provided.Of the five patients, one sudden death occurred three months after the implant procedure.No statement was made suggesting a causal or contributory relationship between melody and the death.Of the five patients, one patient required intra-operative revision for lvot obstruction due to the stent.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: 12502176
• MDR Text Key: 272454666
• Report Number: 2025587-2021-02850
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• 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: 08/24/2021
• 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: 11 MO
• Patient Weight: 7