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

Model Number PB1018

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

Patient Problem Endocarditis (1834)

Event Date 11/15/2021

Event Type  malfunction  

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 approximately two years and ten months following the implant of this transcatheter pulmonary bio prosthetic valve, a stent fracture was reported.An increased gradient and endocarditis were noted.No treatment was reported.No adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the device history record of this valve was reviewed, and no anomalies were noted that would have impacted this event.A review of the sterility lot record confirms that the biological indicators (bi) tested negative for both tissue and solution.The tissue bioprosthetic heart valve product manufacturing processes involves a series of tissue treatments to fix the tissue and to reduce the bioburden level prior to the terminal sterilization step to yield a sterile product.The sterilization process used has an anti-microbial kill on the microorganisms.Additionally, acceptable sterility testing result is a requirement for finished product release.Endocarditis that occurs more than 12 months after the procedure are called late prosthetic-valve endocarditis and are largely commu nity-acquired versus a result of the manufacturing process of the valve (refer to note 1).Based on the above investigation, endocarditis is unlikely to be caused by the melody device and/or manufacturing process.Per melody instructions for use (ifu), 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¿.The endocarditis and/or the reported stent fracture may have caused the reported high gradients.¹ mylonakis, e., and calderwood, s.B.Infective endocarditis in adults.New england journal of medicine.345 (18).1318-1330.Nov.1, 2001.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): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12866551
• MDR Text Key: 281523679
• Report Number: 2025587-2021-03571
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00643169588196
• UDI-Public: 00643169588196
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2020
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Date Device Manufactured: 03/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Male