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

Model Number PB 10

Device Problems Gradient Increase (1270); Perivalvular Leak (1457)

Patient Problems Arrhythmia (1721); Insufficiency, Valvular (1926); Tachycardia (2095); Obstruction/Occlusion (2422)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

Citation: krasemann t et al.Gradient over melody valve in left av valve position reduces with beta blockade.Cardiol young.2019 au g;29(8):1110-1111.Doi: 10.1017/s1047951119001616.Epub 2019 jul 23.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.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a female pediatric patient with a history of surgical repair of an atriovent ricular (av) septal defect who underwent implant of a medtronic melody bioprosthetic valve (serial number not provided) in the left av valve ¿supra-mitral¿ position.Post-operative echocardiography showed paravalvular leak and a mean gradient over the valve of 5mmhg.Over an unspecified number of weeks after valve implant, the mean gradient was reported to have increased to 12 mmhg.Echocardiography revealed the patient was tachycardic with premature supraventricular beats.The patient was administered beta blockers which reduced the patient¿s heart rate and decreased the mean gradient to 5 mmhg.Six weeks later, a non-medtronic balloon was used to dilate the melody valve from 12 mm to 14 mm in diameter due to a left ventricular outflow tract obstruction.After the balloon dilation procedure, it was noted that the gradient over the valve was rate dependent and beta blockers were continued to be administered to the patient.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: 9521751
• MDR Text Key: 187046157
• Report Number: 2025587-2019-03888
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• 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: 12/04/2019
• 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): Required Intervention