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

Model Number PB1018

Device Problem Gradient Increase (1270)

Patient Problem Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 02/02/2022

Event Type  Injury  

Event Description

Medtronic received information that prior to the implant of this transcatheter pulmonary bioprosthetic valve into a patient with a stenosed pulmonary conduit, pre-stenting was performed using a 34 millimeter (mm) stent.Approximately nine years and seven months following the valve implant, the patient experienced cardiac decompensation.Catheterization revealed severe pulmonary insufficiency and rv-pa (right ventricle-pulmonary artery) gradient of 50 millimeters of mercury (mmhg).Approximately two years and nine months following the valve implant, the valve and pre-stent were dilated using a 24mm non-medtronic balloon, and a second valve was subsequently implanted.A final rv-pa gradient of 6 mmhg was reported with no pulmonary insufficiency.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received that severe central pulmonary insufficiency was noted after implant of the first valve.The first valve was implanted into a conduit of unknown material.Correction: the second valve was implanted nine years and nine months following implant of the first valve.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
• 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: 13481276
• MDR Text Key: 285241231
• Report Number: 2025587-2022-00380
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2013
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Date Device Manufactured: 03/30/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 113 KG