MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number	200H12
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Death (1802); Low Blood Pressure/ Hypotension (1914); Sepsis (2067); Complete Heart Block (2627)
Date of Event	12/27/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 or Problem Description
Medtronic received information that 24 hours post implant of this 12mm pulmonary valved conduit used in this pediatric patient in the mitral position there were positive blood cultures for sepsis.The cause of sepsis was unknown as the patient was very sick with an open chest.The pulmonary conduit was implanted inside of a 14mm dacron tube due to severe mitral regurgitation.Three days post implant the patient experienced complete atrio-ventricular (av) block, persistent hypotension and moderate aortic insufficiency requiring escalation in extracorporeal membrane oxygenation (ecmo) flows.This case was further complicated by right sided seizure activity.There was increasingly elevated lactates and progressive acidosis.Three days later, after discussing with the patient's family regarding the grim short and long term prognosis, they requested to discontinue all heroic life support measures.The patient was discontinued from extracorporeal and ventilator support and passed away immediately thereafter.No autopsy was performed and the device remains in the patient and will not be returned.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONTEGRA
• Common Device Name: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8260606
• Report Number: 2025587-2019-00259
• Device Sequence Number: 1234050
• Product Code: MWH
• UDI-Device Identifier: 00643169616899
• UDI-Public: 00643169616899
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: H020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 200H12
• Device Catalogue Number: 200H12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 03/12/2019
• 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: Death; Required Intervention
• Patient Age: 11 DA
• Patient Weight: 4