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

Model Number PB1018

Device Problems Fracture (1260); Gradient Increase (1270)

Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); Regurgitation, Valvular (2335)

Event Date 06/01/2019

Event Type  Injury  

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.

Event Description

Medtronic received information that sixteen years, ten months, four days following the implant of this transcatheter pulmonary bioprosthetic valve (serial number unknown), pulmonary stenosis and pulmonary insufficiency with stent fractures were reported.A valve-in-valve procedure was performed with a second melody valve.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information.Of note, the previously reported central pulmonary insufficiency and stenosis was first identified approximately fifteen years (rather than sixteen years as previously reported), nine months, and twenty-one days following the pulmonary valve implant.The patient had not been followed for some time and upon being seen high gradients were noted which resulted in the dilation.As reported, high gradients caused the stent fractures.The type iv fractures occurred prior to the dilation.It was one year and fourteen days later that the valve was revised due to the stent fractures (rather than thirteen days later as previously reported).No additional adverse patient effects were reported.Corrected data: b3 (impacts date context in b5 updated in h10) updated data: a2 and h6 device code 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.

Manufacturer Narrative

Additional information was received which indicated that sixteen years, nine months and twenty-two days following the pulmonary valve implant, severe central pulmonary insufficiency and stenosis was identified.Dilation was performed on this same date.As reported, the cause of the stent fractures was likely due to no pre-stent.Thirteen days later the valve was revised as previously reported.No additional adverse patient effects were reported.Updated data: b3 and h.6 patient code 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.

Manufacturer Narrative

Updated data: h6 - eval method code, eval results code, eval conclusion code corrected data: b5 - as reported, the fractures caused the high gradients.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.Still and movie photo clips related to this event were received.The photos and movie confirm there are multiple stent fractures seen in stent frames.However, the imaging cannot confirm the gradients or regurgitation as mentioned in the event report.Based on clinical data and literatures, melody stent fractures are known phenomenon.Prominent mechanical stresses on the outflow tract stent, such as compression between the anterior chest wall and heart, appear to be associated with an increased risk of stent fracture.However, a true root cause of the stent fractures cannot be determined with the limited information available.In this case, it was reported that the cause of the stent fractures was likely due to no pre-stent.It is important to note that clinical practice has evolved over time to include the utilization of pre-stenting prior to the implantation of melody transcatheter pulmonary valve (tpv).This practice effectively expands the pre-implant right ventricular outflow tract (rvot), creates a more uniform implant site, and reduces the loading on the implanted tpv, all which help to mitigate the risk of frame fracture (nordmeyer, et al., 2007 and demkow, et al., 2011).The stent fracture may have led to the reported regurgitation, high gradients, and stenosis; but a conclusive cause of the issues cannot be determined.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 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: 10179891
• MDR Text Key: 195956800
• Report Number: 2025587-2020-01985
• 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,Followup,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• 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: 70