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

Model Number	200SH
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	09/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the return of the product, no definitive conclusion can be made regarding the clinical observation.
Event or Problem Description
Medtronic received information that 7 years 1 month post implant of this pulmonary bioprosthetic valved conduit in a pediatric patient, the device was replaced valve-in-valve with a transcatheter pulmonary valve (tpv) for unknown reasons.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Additional information received indicated that the device was replaced due to multiple areas of stenosis and calcification of the conduit.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 VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6936753
• Report Number: 2025587-2017-01801
• Device Sequence Number: 483074
• Product Code: MWH
• UDI-Device Identifier: 00613994600189
• UDI-Public: 00613994600189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2013
• Device Model Number: 200SH
• Device Catalogue Number: 200SH18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 11/01/2017
• 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: Required Intervention
• Patient Age: 11 YR
• Patient Weight: 61