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

Model Number PB 10

Device Problems Gradient Increase (1270); Obstruction of Flow (2423); Material Split, Cut or Torn (4008)

Patient Problems Mitral Valve Stenosis (1965); Regurgitation, Valvular (2335)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

Citation: grandinetti m et al.First surgical melody valve-in-valve implantation for early degeneration in mitral position.Ann thorac surg.2018 apr;105(4):e169-e170.Doi: 10.1016/j.Athoracsur.2017.10.024.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 a (b)(6) year-old male patient with a reported history of shone¿s complex who previously underwent implant of a medtronic melody bioprosthetic valve (serial number not provided) in the mitral position for severe mitral valve stenosis and regurgitation.Two years following the valve implant, the patient presented with mitral stenosis.An echocardiogram revealed stenosis of the melody valve with a mean transvalvular gradient of 22 mm hg and severe valve regurgitation.Subsequently, a second melody valve (serial number not provided) was surgically implanted valve-in-valve in the initial valve.It was reported that once the initial melody valve was exposed, one leaflet showed two lacerations.During the 12 months of follow-up, echocardiographic evaluation showed good function of the second valve with no residual stenosis.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: 8096496
• MDR Text Key: 128103628
• Report Number: 2025587-2018-03161
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/21/2018

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: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/21/2018
• 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: 3 YR