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

Model Number	PB1016
Medical Device Problem Codes	Fracture (1260); Gradient Increase (1270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Medtronic received information that five years, five months, and sixteen days following the implant of this transcatheter pulmonary bioprosthetic valve, increased system right ventricular and pulmonary artery pressures were noted.Balloon dilation x2 of the valve was required due to a valve gradient of 48 millimeters of mercury (mmhg).Valve fluoroscopy identified a proximal stent fracture and a new melody valve was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was received that the fracture was noted after the balloon dilation, prior to implanting the second valve.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.
Additional 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.Two fluoroscopy films were received which confirmed the reported stent fracture.Without the device returned for analysis, the root cause of the stent fracture cannot be determined.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, in this case, a true root cause to the stent fractures is not determined.It was reported that the fracture was noted after the balloon dilation which suggested that the balloon dilation would be a contributing/potential cause of the stent fracture.With the limited information available, the cause of the high gradient cannot be determined.Updated data: h6 result and conclusion codes.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
• Common Device Name: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9437546
• Report Number: 2025587-2019-03666
• Device Sequence Number: 3175137
• Product Code: NPV
• UDI-Device Identifier: 00643169415850
• UDI-Public: 00643169415850
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P140017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2016
• Device Model Number: PB1016
• Device Catalogue Number: PB1016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 01/06/2020; 02/06/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/09/2020; 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Weight: 52