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

Model Number PB1018

Device Problems Positioning Failure (1158); Material Separation (1562); Device-Device Incompatibility (2919)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the product had not been returned; therefore, no product analysis can be performed.  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 during the attempted implant of this transcatheter pulmonary valve (tpv) with a non-medtronic, off labeled 24-millimeter (mm) balloon-in-balloon (bib) catheter, implant complications occurred.It was noted that a large ventricular outflow tract measuring approximately 24mm was encountered.Multiple attempts were made to advance the system through a 22 french mullins sheath.Despite various maneuvers, it proved impossible to advance the valve into position during manipulations, without the valve becoming incorrectly positioned on the delivery balloon.The valve was not able to be deployed and it was reported that the difficultly was caused by the inability to properly sheath the valve.Upon removal of the valve from the mullins sheath, there appeared to be a possible partial detachment of valve material from the stent.Valve material appeared to be outside of the stent.It was then decided to not implant the valve.No adverse patient effects were reported.

Manufacturer Narrative

Additional information was reported that after the valve and delivery system were removed from the patient, the valve was inspected.Upon inspection, some of the material had pulled away from the valve¿s stent.It was reported that none of the material completely separated and none appeared to be left in the patient.No intervention was required.No adverse patient effects were reported.Eval code method, eval code-result, eval code-conclusion.Product analysis: the product has been returned for analysis.A supplemental report will be filed upon completion of the analysis.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

Analysis: the valve was received via fedex in its original packaging and original container jar, submerged in lightly yellow clear solution.The valve appeared to have been crimped uniformly.The stent appears damage free with no visible stent fractures.Leaflets appeared to be in the closed position in its crimped received condition.Viewable leaflets appeared to be intact.Due to the receipt condition, the condition of the commissures cannot be assessed.Melody subject matter experts examined the returned valve and did not identify any tissue or frame anomalies.The textured appearance on the exterior of the vale is the adventitia of the conduit.This is considered to be common and acceptable with vessel tissue 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 received for analysis.The melody had been crimped.There was no damage observed on the stent and the leaflets.In addition, a visual examination of the returned valve was performed by the subject matter expert upon receipt.Based on the examination results, the small ¿fiber-like¿ tissue were noted on the exterior of the valve.This ¿fiber-like¿ tissues are the adventitia which could be found on the surface of the melody tissue and it is part of the native tissue; it will not impact the safety, efficacy, and durability of the valve.Also, the examination did not reveal / identify any tissue or frame anomalies.The reported "material had pulled away from the valve¿s stent" observation cannot be confirmed.Potential factors that can influence positioning difficulty include anatomy landmark visibility, patient pre-existing conditions such as calcification levels, compliance of native anatomy as well as procedural complications, tension applied on the dcs during positioning and a number of others.In this case it was reported the difficulty was caused by the inability to properly sheath the valve, and a non-medtronic delivery system was used.This indicates that the most likely cause of the positioning / deployment difficulties was user related (used a non-medtronic catheter delivery system).There is no information to suggest a device quality deficiency that may have caused or contributed to this event.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: 9199418
• MDR Text Key: 166392764
• Report Number: 2025587-2019-03166
• 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,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2020
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 67