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

Model Number 200H18

Device Problems Calcified (1077); Gradient Increase (1270)

Patient Problem Pulmonary Valve Stenosis (2024)

Event Date 06/22/2021

Event Type  Injury  

Event Description

Medtronic received information that 5 years and 10 months post implant of this 18mm pulmonary valved conduit in a (b)(6) pediatric patient, it was explanted and replaced with a non medtronic product.The reason for replacement was reported as severe conduit stenosis.It was also reported that the conduit was heavily calcified especially around the distal anastomosis. also, a peak gradient of 65mmhg and 52mmhg after balloon angioplasty were noted on echocardiogram. no additional adverse patient effects were reported.

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.

• Brand Name: CONTEGRA
• Type of Device: 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13335971
• MDR Text Key: 284351968
• Report Number: 2025587-2022-00159
• Device Sequence Number: 1
• Product Code: MWH
• UDI-Device Identifier: 00643169357112
• UDI-Public: 00643169357112
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 200H18
• Device Catalogue Number: 200H18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 01/24/2022
• Date Device Manufactured: 07/21/2015
• 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; Hospitalization
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 54 KG