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

Model Number PB1016

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Heart Failure (2206)

Event Date 04/12/2017

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.

Event Description

Medtronic received information that during the implant of this transcatheter pulmonary bioprosthetic valve, into a patient with single ventricle physiology that had severe mitral stenosis and a small left ventricle cavity with good systolic function, it was reported the valve implant was uneventful however the left ventricle was unable to handle the loading conditions.Acute systolic dysfunction, marked elevation in diastolic pressure, signs of ischemia, and hemodynamic impairment were noted.The valve was surgically removed and the patient was restored to single ventricle physiology.No further adverse patient effects were reported.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 6621485
• MDR Text Key: 76960901
• Report Number: 2025587-2017-00932
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00643169588189
• UDI-Public: 00643169588189
• 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
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2018
• Device Model Number: PB1016
• Device Catalogue Number: PB1016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/08/2017
• Supplement Dates Manufacturer Received: 05/18/2017
• Supplement Dates FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2016
• 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: 28 MO
• Patient Weight: 11