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

Model Number 200H14

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

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

Event Date 10/29/2019

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 2 years and 4 months post implant of this 14mm pulmonary valved conduit in an (b)(6)-month-old pediatric patient, it was explanted and replaced with an 18mm pulmonary valved conduit of the same model.The reason for replacement was not reported.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information.It was reported that the pulmonary valved conduit was severely calcified, particularly at the proximal and distal anastomosis sites.As a result, the conduit was severely stenotic.Concomitant with the conduit replacement, the patient's left and right pulmonary artery branches were augmented with a patch.This was performed due to stenosis, reported to be a result of scar tissue and calcification surrounding the conduit anastomosis.Additionally, it was reported that the proximal right ventricular outflow tract (rvot) was obstructed, but below the level of the conduit.It was reported that this obstruction was muscular in nature.As a result, a portion of the rvot muscle bundle was resected.The patient tolerated the procedure well, and no additional adverse patient effects were reported.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: 9394799
• MDR Text Key: 168598059
• Report Number: 2025587-2019-03625
• 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: 02/19/2020

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
• Device Operator: Health Professional
• Device Model Number: 200H14
• Device Catalogue Number: 200H14
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 MO