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

Model Number PB 10

Device Problem Gradient Increase (1270)

Patient Problems Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

Citation: otero luna a, et al.Successful transcatheter balloon valvuloplasty of previously placed transcatheter pulmonary valve years after initial placement: a report of 2 cases.Pediatric cardiology.Abstracts: pics-aics virtual symposium september 10¿12, 2020; 41:1256-1257.Doi: 10.1007/s00246-020-02408-w.Published: 31 july 2020.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 two cases of transcatheter pulmonary valve stenosis treated with balloon valvuloplasty.Patient two: a (b)(6) male patient with a history of with complete atrioventricular canal defect with tetralogy of fallot.At (b)(6), the patient underwent successful transcatheter pulmonary valve replacement with an 18 mm medtronic melody (unique device identifier number not provided) for right ventricular outflow tract patch stenosis.Four years later, at approximately (b)(6), severe stenosis (peak 70 mmhg, mean 38 mmhg) across the melody was noted.Subsequently, a post-dilation was performed using a 20 mm balloon.Afterward, a gradient of 2 mmhg and mild pulmonary insufficiency were observed.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: 12483555
• MDR Text Key: 271787385
• Report Number: 2025587-2021-02822
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• 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 YR