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

Model Number 200H20

Device Problem Calcified (1077)

Patient Problem Pulmonary Insufficiency (2022)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product remains implanted; therefore, 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 13 years and 3 months post implant of this pulmonary valved conduit in a (b)(6)-year-old pediatric patient, it was replaced valve-in-valve with a transcatheter valve.The reasons for replacement were reported as calcification and insufficiency.No additional adverse patient effects were reported.

• Brand Name: CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8875178
• MDR Text Key: 153711248
• Report Number: 2025587-2019-02523
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2019

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 Model Number: 200H20
• Device Catalogue Number: 200H20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Weight: 60