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

Model Number PB1018

Device Problems Off-Label Use (1494); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem Mitral Insufficiency (1963)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

Product analysis: the valve was not returned; therefore, no product analysis could be performed.Conclusion: without return of the product, no definitive conclusion could be made 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 pulmonary bioprosthetic valve, implanted in the mitral position, moderate-severe central regurgitation was noted.Subsequently, the valve was explanted and another melody valve was implanted successfully.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient information: updated name, gender and date of birth.Eval code method: 4114 no longer applies.Eval code-result: 3221 no longer applies.Eval code-conclusion: 67 no longer applies.Analysis: upon receipt at medtronic¿s quality laboratory, the valve was received in an explant kit, fully submerged in 0.2 % glutaraldehyde solution.The valve appeared to be misshapen.The outflow and inflow crowns were bent outward with exception to one outflow crown.All leaflets were partially opened, and all commissures appeared to be intact.All leaflets were flexible and a frayed tear was noted along the free margin of one of the leaflets.Conclusion: medtronic received information that following the implant of this melody transcatheter bioprosthetic pulmonary valve in the mitral position (off label use), moderate to severe central regurgitation was noted.Subsequently, the valve was explanted and a new melody transcatheter valve was implanted successfully.No additional adverse patient effects were reported.A device history record (dhr) was reviewed.This device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The device was returned for analysis.The outflow and inflow crowns were bent outward with exception to one outflow crown.All commissures appeared to be intact.A frayed tear is noted along the free margin of one of the leaflets.The tear could have led to the reported regurgitation.A conclusive cause of the tear could not be determined, it could have happened during implant/explant.In addition, the valve appeared to be ¿misshapen¿ (not circular / distorted), which could lead to leaflets incomplete coaptation and causing regurgitation.Due to the leaflet damage/frame modification, hydrodynamic functional testing for coaptation could not be performed.In addition, the melody instructions for use (ifu) states ¿the melody¿ tpv is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dys functional 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 melody for any design related testing for patients who re quire replacement of their native mitral valve nor does medtronic have any data to support the use of melody 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 TRANSCATHER 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: 8252845
• MDR Text Key: 133218964
• Report Number: 2025587-2019-00222
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00643169588196
• UDI-Public: 00643169588196
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2020
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• 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: 7 YR
• Patient Weight: 30