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); Obstruction of Flow (2423)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Mitral Regurgitation (1964); Vascular System (Circulation), Impaired (2572); Complete Heart Block (2627)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

Citation: sullivan pm et al.Further percutaneous dilation of a melody® valve in the mitral position to accommodate somatic growth in a small child: lessons learned.Cardiol young.2019 feb;29(2):235-237.Doi: 10.1017/s1047951118001944.Epub 2018 dec 4.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 (b)(6)-month-old female patient (weight (b)(6) kg) who previously underwent repair of a complete atrioventricular canal defect with severe congenital left-sided atrioventricular regurgitation with commissuroplasty at 5 months of age.However, a post-operative transesophageal echocardiogram still showed severe valvular insufficiency and 3 days later the patient had a medtronic melody bioprosthetic valve (serial number not provided) implanted in the mitral position.A transesophageal echocardiogram exhibited that the valve and the left ventricular outflow tract were unobstructed with trace regurgitation.Ten months later, a follow-up echocardiogram showed no insufficiency and a mean gradient of 18-20 mmhg.Subsequently, a dilation of the melody valve was performed with a 14 x 20 mm non-medtronic balloon.During inflation (balloon was reported to be dilated to 20 atm within the valve), the balloon was noted to have slipped back towards the atrium and preferentially expanded the proximal portion of the valve.After balloon deflation, the patient developed complete heart block and became hypotensive.Sinus rhythm resumed shortly, yet the patient remained hypotensive and bradycardic.An echocardiogram revealed poor left ventricular systolic function and a dilated right ventricle, alleged to be due to acute pulmonary hypertension.It was reported that the distal portion of the valve stent was distorted and narrowed causing acute obstruction.A second balloon dilation was performed of the entire length of the melody valve.The patient¿s hemodynamics rapidly recovered, and an echocardiogram revealed ¿unobstructed laminar flow through the melody valve¿ and the mean gradient was improved to 9 mmhg.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: 8772724
• MDR Text Key: 150456766
• Report Number: 2025587-2019-02177
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• 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: 06/24/2019
• 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
• Patient Age: 15 MO
• Patient Weight: 8