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

Model Number 200H20

Device Problems Calcified (1077); Insufficient Information (3190)

Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); No Information (3190)

Event Date 07/23/2019

Event Type  Injury  

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 Description

Medtronic received information that 9 years and 7 months post implant of this 20mm pulmonary valved conduit in a (b)(6) pediatric patient, it was replaced valve-in-valve with a transcatheter valve.The reason for replacement was not reported.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received information that the reason for replacement was due to heavy calcification on the conduit, along with severe stenosis and mild regurgitation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8906958
• MDR Text Key: 154755420
• Report Number: 2025587-2019-02605
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• PMA/PMN Number: H020003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2011
• Device Model Number: 200H20
• Device Catalogue Number: 200H20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR
• Patient Weight: 60