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

Model Number	200SH16
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pulmonary Valve Stenosis (2024); No Information (3190)
Date of Event	10/17/2018
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 8 years and 4 months post implant of this pulmonary valved conduit in a 5 year old pediatric patient, a transcatheter pulmonary bioprosthetic valve (tpbv) was implanted valve-in-valve.The reason for intervention was not reported.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Medtronic received additional information that the valved conduit was replaced due to severe stenosis.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 VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8046967
• Report Number: 2025587-2018-02986
• Device Sequence Number: 1484509
• Product Code: MWH
• UDI-Device Identifier: 00613994600165
• UDI-Public: 00613994600165
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

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: 12/30/2012
• Device Model Number: 200SH16
• Device Catalogue Number: 200SH16
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 01/25/2019
• 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: Required Intervention
• Patient Age: 13 YR
• Patient Weight: 38