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

Model Number PB10

Device Problem Fracture (1260)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at medtronic's quality laboratory, the melody valve was returned inside the hancock conduit.There appeared to be a bare metal stent between the melody and the hancock conduit.Due to the return condition of the device, the melody commissures cannot be assessed.Presence of vegetation cannot be confirmed.Pannus lined the inside lumen of the melody valve at the inflow and outflow.Pannus appeared to fuse all the device together.Radiography showed evidence of calcification on the loose conduit pieces that were lined with pannus.The bare metal stent appeared to be at the outflow section of the melody valve.Loose stent fragments were most likely pieces from the bare metal stent.Calcification was revealed in the inner wall.Calcification was confirmed on the existing melody leaflets.A stent fracture was revealed on the melody frame (inflow).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that approximately six years and nine months following the implant of this transcatheter bioprosthetic valve, the valve was explanted and replaced with a medtronic surgical valve due to the endocarditis.No further adverse patient effects were reported.

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.There were no other valves in this lot reported for infection or endocarditis.Pannus and calcification can lead to immobile leaflets which can cause high gradient.Based on clinical data and literature, 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 observed stent fracture is not determined.The sterilization process used by medtronic has an anti-microbial kill on the microorganisms such as staphylococcus and streptococcus species.This process is validated using the worst-case bacillus atrophaeus (gram positive spore forming rods), which is known to be representative of the clean room bioburden.There reported organism can be rendered during the sterilization process.The information received also indicates that the infection occurred six years post implant.Infection that occurs more than twelve months after the procedure are largely community-acquired versus a result of the manufacturing process of the valve.Based on the above investigation, the infection is unlikely to be attributed to the valve and/or manufacturing process.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7526519
• MDR Text Key: 108724325
• Report Number: 2025587-2018-01180
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00613994663962
• UDI-Public: 00613994663962
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2013
• Device Model Number: PB10
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2011
• 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: 17 YR
• Patient Weight: 59