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

Model Number	200H14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 1 year and 1 month post implant of this 14mm pulmonary valved conduit in a (b)(6) pediatric patient, it was explanted and replaced with a 14mm conduit of the same model.The reason for replacement was reported to be dilation of the conduit due to a distal obstruction.It was mentioned that there was dense fibrous reaction at the pulmonary artery confluence.It was stated that this was fully dissected.It was noted that a transesophageal echocardiogram performed after replacement of the conduit showed a gradient of approximately 20 to 25mmhg in the proximal right pulmonary artery.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
No product was returned.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.

• Brand Name: CONTEGRA
• Common Device Name: PULMONIC VALVED CONDUIT
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15317578
• Report Number: 2025587-2022-02404
• Device Sequence Number: 12234260
• Product Code: MWH
• UDI-Device Identifier: 00643169616905
• UDI-Public: 00643169616905
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: H020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/29/2022

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: 11/12/2023
• Device Model Number: 200H14
• Device Catalogue Number: 200H14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/30/2022
• Date Device Manufactured: 11/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 13 MO
• Patient Sex: Female