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

Model Number PB 10

Device Problem Insufficient Information (3190)

Patient Problems Vascular Dissection (3160); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 03/30/2015

Event Type  Injury  

Manufacturer Narrative

Citation: finch w, et al.Transcatheter melody valve placement in large diameter bioprostheses and conduits: what is the optimal ¿landing zone¿? catheter cardiovasc interv.2015 nov;86(5):e217-23.Doi: 10.1002/ccd.25922.Epub 2015 mar 30 earliest date of publish used for event date.Medtronic products referenced: melody (pma# p140017, product code npv).Earliest approved product used for product code and pma#.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 use of transcatheter valves within failed bioprosthetic valves (bpv) located in the right ventricular outflow tract (rvot).The aim was determining the optimal size of the bpv conduit prior to conducting transcatheter implantation for best outcomes.All data were collected from multiple centers between october 2010 and june 2014.The study population included 52 patients (predominantly male, mean age 21 years), all of whom were implanted with medtronic melody bioprosthetic valves (no serial numbers provided).Among all medtronic melody patients, one death occurred directly due to infective endocarditis involving the melody valve.Based on the available information medtronic product was directly associated with the death.Among all medtronic melody patients, adverse events included: one case of femoral artery dissection during implantation and trivial-mild pulmonary valve regurgitation noted during long-term follow-up.Based on the available information medtronic product may have been associated with the adverse events.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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 10903596
• MDR Text Key: 218242507
• Report Number: 2025587-2020-03622
• 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: 11/25/2020

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: Lay User/Patient
• 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: 10/30/2020
• Initial Date FDA Received: 11/25/2020
• 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): Other
• Patient Age: 21 YR