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

Model Number	200SH14
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: no product was returned.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 6 years and 5 months post implant of this 14 mm pulmonary valved conduit in a (b)(6) old pediatric patient, it was explanted and replaced with a 18 mm conduit of the same model.The reason for replacement was reported as pulmonary stenosis and mild pulmonary regurgitation.It was also reported that the conduit was calcified.No additional adverse patient effects were reported.

• 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: 10700496
• Report Number: 2025587-2020-03150
• Device Sequence Number: 14379865
• Product Code: MWH
• UDI-Device Identifier: 00613994600141
• UDI-Public: 00613994600141
• 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
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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: 04/14/2014
• Device Model Number: 200SH14
• Device Catalogue Number: 200SH14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/19/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 22