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

Model Number 200S

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem Pulmonary Valve Stenosis (2024)

Event Date 09/11/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted as part of a retrospective review and remediation for capa 564121 per (b)(4).Citation: haddad et al.A new solution for stenting large right ventricular outflow tracts before transcatheter pulmonary valve rep lacement.Can j cardiol.2022 jan;38(1):31-40.Doi: 10.1016/j.Cjca.2021.08.021.Epub 2021 sep 11.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Medtronic received information via literature regarding solutions for stenting large right ventricular outflow tracts before the implant of a transcatheter pulmonary valve (tpv).All data were collected from a single center between june to november 2020.Two patients were implanted with a medtronic device.A female patient with tetralogy of fallot (tof) was implanted with a medtronic contegra pulmonary conduit.During a procedure the stenosed conduit was pre-stented in order to place a non-medtronic transcatheter pulmonary valve.While placing the stent the conduit ruptured.An additional stent was placed to successfully repair the conduit damage.No additional adverse patient effects or product performance issues were reported.

• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18894986
• MDR Text Key: 337558674
• Report Number: 2025587-2024-01608
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 200S
• Device Catalogue Number: 200S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• 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): Life Threatening; Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 53 KG