MAUDE Adverse Event Report: HEART VALVES SANTA ANA MELODY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI

Model Number PB1018

Device Problem Fracture (1260)

Patient Problem Pulmonary Valve Stenosis (2024)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

Product analysis: the valve remains implanted therefore no product analysis can be performed.Conclusion: without 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 four years and ten months following the implant of this transcatheter pulmonary bi oprosthetic valve, a second transcatheter pulmonary bioprosthetic valve was implanted valve-in-valve.It was reported from the implanting physician that the valve was replaced due to non-transverse fractures of multiple valve stents, resulting in a "trap door effect" and severe valve stenosis.Two stents were placed as a landing zone prior to the first valve implant and these stents were not fractured.No additional adverse patient effects were reported. .

Manufacturer Narrative

Conclusion: the device history record (dhr) of this valve was reviewed and no anomalies were noted that would have impacted this event.This product met all manufacturing specifications for product released to distribution.Per the device instructions for use (ifu), melody stent fractures are known phenomenon.It states that ¿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 conclusive root cause of the stent fractures cannot be determined with the limited information available.In this case, it was reported that the multiple stent fractures resulting in a ¿trap door effect¿ and stenosis.Based on the risk an alysis, stent fractures can potentially lead to stenosis.The reported ¿trap door effect¿ was due to the side of the device being within the right ventricle outflow column.The frame was getting constantly ¿pushed¿ during each cardiac output cycle, which led to fracture on one side of the frame.The common treatment consists of stenting until no recoil, following by a second valve implant.In this case, a second valve was implanted.Updated: h6.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 DELI
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 11887148
• MDR Text Key: 252767648
• Report Number: 2025587-2021-01697
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Weight: 76