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

Model Number PB1018

Device Problem Incomplete Coaptation (2507)

Patient Problems Pulmonary Regurgitation (2023); Stenosis (2263); Vascular System (Circulation), Impaired (2572)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product remains implanted; therefore, no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusions can be made.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that approximately seven years and five months following the implant of this transcatheter pulmonary bioprosthetic valve into an unknown previous bioprosthetic valve (bpv), an intracardiac echocardiography (ice) showed moderate obstruction, stenosis and moderate pulmonary regurgitation (pr) with prolapse of one of the leaflets into right ventricular outflow tract (rvot) during diastole.A balloon aortic valvuloplasty (bav) was used to expand the existing bpv and pulmonary valve.As reported, the bav fractured the previous bpv and likely relieved the obstruction.Moderate pr remained and a second bioprosthetic transcatheter pulmonary valve was implanted within the existing pulmonary valve.No additional adverse patient effects were reported. .

Manufacturer Narrative

Additional information was received that the physician believed the cause of the obstruction was due to leaflet calcification.It was reported that the transcatheter pulmonary bioprosthetic valve was placed into a slightly undersized previous unknown manufacturer's bioprosthetic pulmonary valve.Moderate pulmonary regurgitation remained following the valve implant.No treatment was reported.No additional adverse patient effects were reported.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
• MDR Report Key: 8709938
• MDR Text Key: 148406538
• Report Number: 2025587-2019-01967
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00613994663962
• UDI-Public: 00613994663962
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2013
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 123