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

Model Number PB1016

Device Problem Insufficient Information (3190)

Patient Problems Mitral Regurgitation (1964); No Information (3190)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product was not returned, therefore no product analysis could be completed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that following the implant of this transcatheter bioprosthetic pulmonary valve, implanted in the mitral position, the valve was removed for an unknown reason and was replaced with a non-medtronic valve.No additional adverse patient effects were reported. .

Manufacturer Narrative

The valve was replaced due to severe central regurgitation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve was received discolored with evidence of blood contact.A blue monofilament suture was loosely attached to the valve.The valve appeared to be misshapen.The outflow and inflow crowns were bent outward.In dry condition, two leaflets were in the closed position while one leaflet was in the open position.In submerged condition, leaflets appeared to be in the closed position with gaps between the free margins.The outflow crowns were bent outwardly which appeared to have pulled back commissure one and two; potentially contributing to the central regurgitation.Commissure three was intact.All leaflets were flexible and intact.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The device was returned for analysis and the valve appeared to be ¿misshapen¿ (not circular/distorted).After a thorough review of the information received from this complaint, device history review, and the return analysis, the condition of the commissures (pulled back outwardly with the crowns) and the condition (distortion) of the valve, may have led to the leaflets incomplete coaptation causing the regurgitation.Due to the valve distortion/frame modification, hydrodynamic functional testing for coaptation cannot be performed.In addition, the instructions for use (ifu) state the device ¿is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (rvot) conduit or surgical bioprosthetic pulmonary valve that has = moderate regurgitation, and/or a mean rvot gradient =35 mm hg.¿ medtronic has not submitted the valve for any design related testing for patients who require replacement of their native mitral valve nor does medtronic have any data to support the use of this valve in the mitral position.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.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: 8366541
• MDR Text Key: 137013250
• Report Number: 2025587-2019-00707
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00643169588189
• UDI-Public: 00643169588189
• 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,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2020
• Device Model Number: PB1016
• Device Catalogue Number: PB1016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 MO