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

Model Number PB1018

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

Patient Problems Fatigue (1849); Unspecified Infection (1930); Thrombosis/Thrombus (4440); Unspecified Heart Problem (4454)

Event Date 10/13/2020

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 four years and eight months following the implant of this transcatheter pulmonary bioprosthetic valve into a previous transcatheter pulmonary bioprosthetic valve, the patient underwent catherization and electrophy siologic examination with ablation for atrial fibrillation (afib).Per the physician, the catherization and afib event were not related to the valve.During the examination, an invasive right ventricular-pulmonary artery (rv-pa) gradient of 50 millimeter of mercury (mmhg) was measured and multiple type three stent fractures of the valve and non-medtronic (cp) pre-stent were observed.No pulmonic insufficiency was reported.Four years, ten months and twelve days following the valve implant, the rv-pa gradient and decrease right ventricular function were confirmed on the follow up visit.Fatigue was reported.Four years, ten months and twenty five days following the valve implant, the patient underwent open heart surgery where the valves and pre-stents were explanted and replaced with a 25 mm medtronic conduit.Following the explant, the surgeon described one leaflet of the valve to be completed immobilized by thrombus.There were no comments made regarding the remaining leaflets.A microbial smear of the thrombosed leaflet revealed corynebacterium species.No positive blood cultures were taken before, during or after the procedure.The patient received two weeks of medication and was discharged uneventfully.No additional adverse patient effects were reported. .

Manufacturer Narrative

Additional information was received that the patient did not have any pre-existing coagulopathy issues or other blood disorders.The patient was on 100 mg of acetylsalicylic acid (ass) following the valve implant.The patient's international normalized ratio (inr) prior to the open heart surgery was 1.2.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

Updated data: a1 - patient identifier conclusion: the device history record (dhr) 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 sterilization process used by medtronic utilities bga solution (sterilant: 0.84-1.16%; 23-24 hour exposure at 38-42°c) which has an anti-microbial kill on the microorganisms such as corynebacterium species; and it also has demonstrated the ability to inactivate the biological indicator, bacillus atrophaeus atcc 9372 which is representative bioburden for the microbial flora found in our ma nufacturing controlled environment.The reported organism (corynebacterium sp.) can be rendered non-viable to the sterilization process during manufacturing.In addition, the information received also indicates that the infection / endocarditis occurred over 4 years after implant.Endocarditis / infection that occurs more than 12 month after the procedure are called late prosthetic-valve endocarditis and are largely community-acquired versus a result of the manufacturing process of the valve (refer to note 1 and 10146231doc).Therefore, it was unlikely that the infection originally came from the device and/or manufacturing valve process.The device was not returned for analysis.There are still images of the valve related to this event received.The images confirm there are multiple stent fractures seen in stent frames and pre-stent.However, the imaging cannot confirm the high gradients as mentioned in the event report.The relationship between the reported high gradients and stent fractures cannot be established.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, a conclusive root cause of the stent fractures cannot be determined with the limited information available.Stent fracture related risks are documented in the risk management files.In addition, there are two photos of the explanted valve provided.A photo analysis review was performed.Thick glistening pannus can be observed on the outflow crown extending to the luminal surface of the valve.From the inflow view, there appears to be host growth on the valve wall that may possibly be vegetation.There also appears to be thrombotic host growth on the inner lumen of the returned unit, which would have significantly impaired the leaflet mobility.The impairment of leaflet mobility may have causing the high gradients.In this case, it was reported that following the explant, the surgeon described one leaflet of the valve to be completed immobilized by thrombus.This indicates that the most probable cause of the high gradients could be immobile leaflet due to thrombus.However, without the return of the device and/or echo report, a detail assessment of the leaflets cannot be performed.The root cause of the thrombus and high gradients cannot be determined.H6 - method code, results code, conclusion code corrected data: b5 - additional information was received that the type of stent fracture observed was type two and not type three.No additional adverse patient effects were reported.  e1 - street 1 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: 11397220
• MDR Text Key: 234241195
• Report Number: 2025587-2021-00724
• 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: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2016
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR