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

Model Number PB1018

Device Problems Gradient Increase (1270); Incomplete Coaptation (2507); Torn Material (3024)

Patient Problems Host-Tissue Reaction (1297); Calcium Deposits/Calcification (1758); Mitral Regurgitation (1964); Pulmonary Edema (2020)

Event Date 01/04/2016

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 six days following the implant of this transcatheter pulmonary bioprosthetic valve, placed in the mitral position with open thorax, a balloon dilatation was performed with an 18 mm ultra-high pressure balloon during thorax closure to reduce the gradient over the valve.Approximately one year and eleven months post-implant, after the patient presented with cardiac decompensation and lung edema, an echocardiogram showed new moderate-severe central mitral regurgitation with a diagonal jet and a mean gradient of 11 mmhg.The leaflets were noted to be thickened.The valve was explanted and replaced with a non-medtronic valve due to the mitral regurgitation.Following explant, a tear of the larger leaflet and thickened commissures were noted.The origination of the tear was opposite to the area removed from the stent to avoid left ventricular outflow tract (lvot) obstruction.It was reported that the patient had a history of congenital atrioventricular (av) canal defect with multiple unsuccessful open-heart surgeries.No further adverse patient effects were reported.

Manufacturer Narrative

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.Melody valves were indicated for the pulmonary position and per specifications, the valve must have three leaflets.The explanted device was not returned for analysis.However, images were provided by the customer.Per the pre-op images, there were three leaflets, and one leaflet dominated the orifice due to its larger size.The melody valve was a native bovine jugular valve, therefore variation in leaflet size was common.A melody/ensemble procedure preparation tip card was available for users as a guide.This included acceptable leaflet variation and described medtronic¿s testing methods in manufacturing prior to releasing valves to distribution.Per the explant images, the valve had existing leaflets.A coaptation gap was observed.Pannus was on the outside wall and in the inner lumen.Cuspal tear on one of the leaflets was observed.At outflow view, possible pannus and calcification were observed.Without the return of the actual device, these observations cannot be confirmed.Based on historical trend: cuspal tear is one failure mode (mechanism) which could lead to regurgitation.Calcification would be the most common cause for cuspal tear.However, without the failure mechanism and the return of the valves for analysis, a true root cause of the regurgitation could not be determined.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: 7147954
• MDR Text Key: 95826289
• Report Number: 2025587-2017-02581
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2017
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2018
• Date Device Manufactured: 11/17/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 6 MO