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

Model Number 200S

Device Problem Calcified (1077)

Patient Problems Unspecified Infection (1930); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Medtronic received information via literature regarding an (b)(6) male patient with a 16-mm contegra conduit (no unique device identifiers provided) who presented with a peak gradient of 64 mmhg and moderate pulmonary valve regurgitation.In a subsequent surgery, a balloon valvuloplasty and three consecutive stents were implanted in the calcified contegra conduit.One month later, the patient underwent successful melody valve (no unique device identifiers provided) implantation.

Manufacturer Narrative

Citation: lorenz et al.A rare case of infective mediastinitis after melody valve implantation.Congenital heart disease, volume 17, pp 187-192; doi.Org/10.32604/chd.2022.018350.Published: 1 january 2022.Earliest date of publish 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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED
• 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: 14322260
• MDR Text Key: 291221444
• Report Number: 2025587-2022-01289
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2022

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 Model Number: 200S
• Device Catalogue Number: 200S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/07/2022
• 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): Required Intervention; Hospitalization; Life Threatening; Congenital Anomaly
• Patient Age: 18 YR
• Patient Sex: Male