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

Model Number PB 10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fistula (1862)

Event Date 08/30/2020

Event Type  Injury  

Manufacturer Narrative

Citation: loureiro et al.Iatrogenic fistula between the aorta and the right ventricular outflow tract after melody valve implantation: case report and literature review.2020 sep;39(9):545.E1-545.E4.Doi: 10.1016/j.Repc.2018.09.016.Epub 2020 aug 30.Earliest date of publish used for event date in b3.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.

Event Description

Medtronic received information via literature regarding an (b)(6) year old female patient born with tetralogy of fallot and an absent pulmonary valve.At (b)(6) years old the patient underwent surgical repair with a 15-mm homograft.At (b)(6) years old the patient underwent successful implantation of a 22-mm medtronic melody valve (no serial numbers provided).During post-procedural follow-up the patient experienced fatigue on moderate exertion.Echocardiography, cardiac catheterization and computed tomography revealed a fistula between the right coronary ostium and the right ventricular outflow tract proximal to the implanted valve.Subsequently the patient underwent surgical repair where the communication was successfully closed with direct sutures.Six months later the patient was asymptomatic with no evidence of the fistula via echocardiogram.A small residual restrictive ventricular septal defect with a gradient of 80 mmhg was documented.No additional adverse patient effects or product performance issues were reported.Of note, the physician/authors speculated that aggressive melody balloon dilatation and/or the strut edges of a non-medtronic stent may have originated the tissue defect.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 10962958
• MDR Text Key: 220695465
• Report Number: 2025587-2020-03701
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P140017
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• 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: 11/11/2020
• 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): Congenital Anomaly; Life Threatening; Required Intervention
• Patient Age: 11 YR