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

Model Number	200H18
Medical Device Problem Codes	Calcified (1077); Gradient Increase (1270)
Health Effect - Clinical Code	Pulmonary Valve Stenosis (2024)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13335971
• Report Number: 2025587-2022-00159
• Device Sequence Number: 4885398
• Product Code: MWH
• UDI-Device Identifier: 00643169357112
• UDI-Public: 00643169357112
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: H020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 01/24/2022
• Date Device Manufactured: 07/21/2015
• 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: Required Intervention; Hospitalization
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 54 KG