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

Model Number PB1018

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Valve Stenosis (2024)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

Citation: kerstein js, et al.Coil embolization to successfully treat right ventricular to pulmonary artery conduit injury during transcatheter interventions.Progress in pediatric cardiology.June 2021, volume 61, 101321.Doi: 10.1016/j.Ppedcard.2020.101321.Available online (b)(6) 2020.Earliest date of publish used for date of event.This report captures the observations associated with the second melody valve implanted during the case.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 series regarding confined conduit tears formed during right ventricular to pulmonary artery (rv-pa) conduit intervention treated with coil embolization.Case 1: a (b)(6)-year-old male patient with a history of congenital aortic valve stenosis, aortic valvotomy at age 5 years, and ross procedure with placement of a 24 mm pulmonary homograft in the rv-pa position at age 12 years.The patient presented with severe conduit stenosis and insufficiency.Following stent placement and angioplasty in the rv-pa conduit in preparation for potential transcatheter valve replacement, angiography detected a contained conduit tear (category 1).To cover the contained tear, the authors decided to implant a 20 mm medtronic melody transcatheter pulmonary valve in the rv-pa conduit.Due to persistent narrowing in the right ventricular outflow tract (rvot), the melody valve was post-dilated with a 20 mm x 2 cm vida balloon to maximum pressure of 20 atm.Afterward, rvot angiography revealed expansion of the conduit tear, but the tear was still contained (category 2).Subsequently, a second melody valve (22 mm size) was implanted valve-in-valve into the first melody.Repeat angiography showed persistent contrast extravasation outside of the conduit, into the mediastinum, contained laterally adjacent to the conduit.Consequently, coil embolization was performed, which successfully treated the conduit tear.The patient was discharged the following day after chest x-ray noted no acute abnormality and echocardiogram exhibited an rvot peak/mean gradient of 31/18 mmhg.At six-month follow-up, echocardiogram showed low normal right ventricle systolic function and mild pulmonary stenosis.Five years post-catheterization, echocardiography detected mild melody valve stenosis (peak/mean gradient of 31/17 mmhg).No unique device identifier numbers were provided.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Updated data: b5.Additional information received from the physician/author stated the following: - the two melody valves were not directly related to the observed adverse events.- the injury to the conduit occurred while creating the ¿landing zone¿ for the first melody valve.- the second melody valve was implanted to act as a covered stent to cover the conduit injury, but since this did not work as intended, the area of conduit injury was coiled.- both melody valves functioned normally.H4.Device mfg date a search of the medtronic global complaint handling database with the provided unique device identifier serial numbers did not find a pre-existing complaint file for these observations.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 DELI
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 12402397
• MDR Text Key: 269523967
• Report Number: 2025587-2021-02712
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2016
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 81