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

Model Number	200H18
Medical Device Problem Codes	Calcified (1077); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Pulmonary Valve Stenosis (2024); No Information (3190)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
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 six years post implant of this 18mm pulmonary bioprosthetic valved conduit implanted in a six year old pediatric patient, the conduit was explanted and replaced with a 20mm valved conduit.The reason for explant is unknown.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Medtronic received additional information that the valve was explanted due to stenosis, heavy calcification and conduit adherence to the leftward aspect of the ascending aorta.No additional adverse patient effects were reported.  patient weight added in section.Patient codes updated in section.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Medtronic received additional information that the valve was explanted due to heavy calcification and conduit adherence to the leftward aspect of the ascending aorta.No additional adverse patient effects were reported.  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: 7930624
• Report Number: 2025587-2018-02628
• Device Sequence Number: 1936967
• Product Code: MWH
• UDI-Device Identifier: 00613994600301
• UDI-Public: 00613994600301
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: H020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2013
• Device Model Number: 200H18
• Device Catalogue Number: 200H18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/01/2018; 02/10/2020
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 10/03/2018; 02/15/2021
• 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: Required Intervention
• Patient Age: 12 YR
• Patient Weight: 28