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

Model Number PB1018

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

Patient Problems Pulmonary Valve Stenosis (2024); Regurgitation, Valvular (2335); Pulmonary Valve Insufficiency/ Regurgitation (4452); Respiratory Insufficiency (4462)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.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 approximately seven years, six months and 11 days following the implant of this transcatheter bioprosthetic pulmonary valve, an angiogram revealed the moderate to severe pulmonary insufficiency and mild stenosis.A gradient of 29 mmhg was reported with a valve diameter of 18 millimeter (mm).The valve and the pre-stents were dilated using a 22mm non-medtronic high pressure balloon.Additional cp covered stents were implanted.A second transcatheter bioprosthetic pulmonary valve melody valve was implanted.All stents and the melody valve were dilated up to 22 mm using a 22 mm non-medtronic balloon.The final result following the implant of the second melody was a gradient of 11 mmhg.No additional adverse patient effects were reported. .

Manufacturer Narrative

Additional information was received that the second melody valve was not post dilated.It was reported that the angiogram and echocardiogram performed revealed a gradient of 29 mmhg, however a mean gradient of 50 to 60 mmhg was calculated in the catheterization lab utilizing pull back of the catheter.No additional adverse patient effects were reported.  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.

Manufacturer Narrative

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.Without the device return for analysis, the root cause of the reported stenosis and regurgitation cannot be determined.In this case, it was noted that a balloon angioplasty was performed and a second melody was implanted valve-in-valve to resolve the stenosis.This indicates that the probable cause of the stenosis could be due to some kind of frame anomalies / expansion (narrowing) issue; however an assignable root cause of the stenosis could not be conclusively determined.Regurgitation can be caused by a variety of factors, however, with the limited information and no images to review, a conclusive cause of the regurgitation 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 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: 10792267
• MDR Text Key: 214779505
• Report Number: 2025587-2020-03443
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2014
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 11/06/2020; 12/18/2020
• Supplement Dates FDA Received: 11/10/2020; 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Weight: 65