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

Model Number	200H12
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Information (3190); No Code Available (3191)
Date of Event	02/12/2020
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 5 months and 9 days post implant of this 12mm pulmonary valved conduit in a (b)(6) old pediatric patient, it was explanted and replaced with a 16mm pulmonary valved conduit of the same model.The reason for replacement was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that changed the event description and device relatedness of this previously reported event.Additional information was received that conduit was coincidentally replaced with a larger size when the patient was taken to surgery for issues with stenosis and dilatation of the branch pulmonary arteries, not because of issues with 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 VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9848689
• Report Number: 2025587-2020-00831
• Device Sequence Number: 2896104
• Product Code: MWH
• UDI-Device Identifier: 00643169616899
• UDI-Public: 00643169616899
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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: 04/18/2021
• Device Model Number: 200H12
• Device Catalogue Number: 200H12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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: Required Intervention
• Patient Age: 8 MO
• Patient Weight: 12