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

Model Number PB 10

Device Problem Gradient Increase (1270)

Patient Problem No Information (3190)

Event Date 04/01/2012

Event Type  Injury  

Manufacturer Narrative

Citation: boudjemline y et al.Branch pulmonary artery jailing with a bare metal stent to anchor a transcatheter pulmonary valve in patients with patched large right ventricular outflow tract.Circ cardiovasc interv.2012 apr 1; 5 (2): e22-5.Doi: 10.1161/circinterventions.112.968610.Earliest date of publish used for event date.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 the 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.

Event Description

Medtronic received information via literature regarding 3 case reports where a melody valve was implanted in a right ventricular outflow tract (rvot) greater than 22 mm in diameter using the pulmonary artery jailing technique.Patient 3: a (b)(6) male who underwent the ross procedure with 23 mm homograft to the rvot in early childhood and later required redo surgery with patch enlargement of the pulmonary homograft and devalvulation along with mechanical aortic valve replacement.The patient presented with gradual decline in functional status, severe pulmonary regurgitation, and no gradient across the rvot.Subsequently, a medtronic melody bioprosthetic valve was implanted (serial number not provided).Two days later, the patient required recatheterization due to elevated left pulmonary artery and right ventricle pressures.Systolic right ventricle and pulmonary artery pressures reduced to 40 mm hg immediately after the intervention.No additional adverse patient effects or product performance issues 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: 8147308
• MDR Text Key: 129800694
• Report Number: 2025587-2018-03369
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: H080002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• 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: 11/18/2018
• 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: 31 YR