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

Model Number PB 10

Device Problem Material Deformation (2976)

Patient Problems Atrial Flutter (1730); Dyspnea (1816); Pulmonary Valve Stenosis (2024); Heart Failure/Congestive Heart Failure (4446); Pulmonary Valve Insufficiency/ Regurgitation (4452); Respiratory Insufficiency (4462); Swelling/ Edema (4577)

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

Citation: kuc m et al.Successful pulmonary homograft re-implantation after previous surgical and percutaneous interventions.Kardiologia polska.2018 february; 76(2):471.Doi: 10.5603/kp.2018.0042.Published online: february 16, 2018.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 case report regarding a male patient with a medical history of tetralogy of fallot with absent pulmonary valve requiring primary repair (at (b)(6) years of age) and later underwent surgical allograft repair due to allograft stenosis (at (b)(6) years of age).Seven years later (at (b)(6) years of age), due to recurrence of pulmonary allograft stenosis, the patient underwent transcatheter pulmonary valve implantation with a medtronic melody (serial number not provided).After the procedure, a right ventricular outflow tract (rvot) peak gradient of 18 mmhg was observed.One-week after melody implant, transthoracic echocardiography (tte) was performed and revealed a gradient of 76/36 mmhg.Two months after melody implant, the valve was expanded with a 22-mm balloon.Following the balloon dilation, the gradient was 35 mmhg, and subsequent tte showed a rvot gradient of 78/44 mmhg.Recurrent stent recoil was diagnosed.The patient was referred to surgery, but did not give consent.Six years after melody implant (at (b)(6) years of age), the patient presented with heart failure and paroxysmal atrial flutter, which impaired cardiac function causing dyspnea at rest and peripheral edema.Tte revealed pulmonary valve stenosis with peak/mean gradient of 130/75 mmhg and small pulmonary valve insufficiency.Cardiac magnetic resonance imaging exhibited large dysfunctional right heart chambers.Computed tomography scan showed stenosis of the pulmonary artery close to the bifurcation and damaged melody valve leaflets.Subsequently, the melody valve and pulmonary allograft were surgically explanted.A 25 mm pulmonary allograft was implanted using root-replacement technique.In the post-operative period, the patient endured right heart insufficiency, which was treated with diuretics.Tte confirmed good allograft function, which was reflected by a peak gradient of 16 mmhg.The patient was discharged 13 days after surgery in good condition without peripheral edema.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Updated data: patient weight provided (258 lbs).Additional information received from the physician/author stated it was thought that the stenotic pulmonary allograft caused the melody stent recoil and increased gradient.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 10945507
• MDR Text Key: 219503669
• Report Number: 2025587-2020-03680
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Weight: 117