MAUDE Adverse Event Report: HEART VALVES SANTA ANA CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number	200H
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pulmonary Valve Stenosis (2024); Regurgitation, Valvular (2335); No Information (3190)
Date of Event	05/09/2017
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 three years, two months post implant of this bioprosthetic pulmonic valve in a pediatric patient, this device was replaced valve-in-valve with a transcatheter pulmonic valve.No failure mechanism and no other adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that this device was replaced valve-in-valve due to significant calcification, with moderate insufficiency and conduit stenosis.Prior to the replacement, the patient presented with moderate tricuspid regurgitation, and moderate blood vessel dilation downstream from valve.No complications were mentioned in the patient's notes resulting from the replacement procedure.No other adverse patient effects were reported.Patient weight added.Patient's relevant medical history added.
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): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6616602
• Report Number: 2025587-2017-00918
• Device Sequence Number: 105975
• Product Code: MWH
• UDI-Device Identifier: 00613994600349
• UDI-Public: 00613994600349
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2017

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: 10/13/2014
• Device Model Number: 200H
• Device Catalogue Number: 200H22
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: Not provided; 06/22/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 06/22/2017; 10/04/2017
• 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: 14 YR
• Patient Weight: 75