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

Model Number	PB10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis after being explanted from the patient after death.It was noted that the patient's death was not related to the device or procedure of this device.Product analysis: upon receipt at medtronic's quality laboratory, the valve was returned inside the patient's pulmonary artery, inside a pre-stent and inside another bioprosthetic transcatheter pulmonary valve.Radiography revealed stent fractures.It cannot be determined which devices had the stent fractures.An embolized stent fragment was noted at the outflow area.Conclusion: the device history record was reviewed and showed that the there was no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing process and the device met all applicable manufacturing specifications prior to release for distribution.Based on the receipt condition of the returned product, stent fractures were noted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 3 years and 2 months post implant of this transcatheter bioprosthetic valve, several minor stent fractures were noted in the proximal half of the stent.No treatment was given and the device remained implanted.
Additional Manufacturer Narrative
Added patient weight of (b)(6) lbs.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Common Device Name: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7047644
• Report Number: 2025587-2017-02219
• Device Sequence Number: 1399177
• Product Code: NPV
• UDI-Device Identifier: 00643169415850
• UDI-Public: 00643169415850
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: H080002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2016
• Device Model Number: PB10
• Device Catalogue Number: PB1016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 64