MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number PB 10

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Regurgitation (2023); Pseudoaneurysm (2605); Vascular Dissection (3160)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

Citation: martin mh.Percutaneous transcatheter pulmonary valve replacement in children weighing less than 20 kg.Catheter cardiovasc interv.2017 nov 29.Doi: 10.1002/ccd.27432.No unique device identifier (serial/lot) numbers were provided; without this information, it could not be determined whether these observations have been previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding percutaneous transcatheter pulmonary valve replacement in children weighing less than 20 kg.All data were collected from multiple centers between january 2010 and january 2017.The study population included 43 patients (predominantly male; median age 6 years), all of whom were implanted with medtronic melody valve.The serial numbers were not provided.3 patients had a medtronic contegra conduit and 1 patient had a 19mm medtronic mosaic implanted in the pulmonary position prior to the melody valve implant.Stenosis and regurgitation were noted in these valves.Among all patients adverse events included: pulmonary artery tear treated with an occlusion device, femoral artery pseudoaneurysm, moderate pulmonary regurgitation, iliac vein injury and conduit tear both treated with a stent implant.There was difficulty advancing the delivery catheter system (dcs) with significant access site bleeding.Based on the available information, these adverse may be attributed to medtronic product.No additional adverse patient effects or products were reported.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• 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: 7203902
• MDR Text Key: 97710006
• Report Number: 2025587-2018-00198
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2018
• 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: 6 YR
• Patient Weight: 18