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

Model Number PB 10

Device Problems Calcified (1077); Gradient Increase (1270)

Patient Problem Stenosis (2263)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device was discarded; therefore, no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Based on the received information, patient outgrowth was a factor for this event.The reported calcification could have caused the stenosis and high gradients.Calcification is an inherent risk of surgical valve replacement.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that approximately six years following the implant of this transcatheter pulmonary bioprosthetic valve, the valve was explanted after an echo showed severe pulmonary valve stenosis with increased gradients.The physician related the explant to both outgrowth and valve deterioration.The valve was reported to be stenosed and calcified.Subsequently, a non-medtronic valve was implanted.No additional adverse patient effects were reported.

• 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
• 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: 8143195
• MDR Text Key: 129649371
• Report Number: 2025587-2018-03339
• Device Sequence Number: 1
• Product Code: NPV
• 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
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 66