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

Model Number PB 10

Device Problems Fracture (1260); Gradient Increase (1270)

Patient Problems Aneurysm (1708); Occlusion (1984); Pulmonary Regurgitation (2023)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Citation: eicken, a.Md.Percutaneous pulmonary valve implantation (ppvi): indications and outcome (2014).Year of presentation was used for event date.No unique device identifier (serial/lot) numbers were provided; without this information, it cannot be determined whether this event has been previously reported.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature review regarding a presentation on percutaneous pulmonary valve implantation.All data were collected from a single center, registry and a medtronic sponsored clinical study.Patient were implanted with a medtronic melody transcatheter pulmonary valve and a non-medtronic transcatheter pulmonary valve.Serial numbers were not provided.The study population was predominantly male; mean age 18.9 years; mean weight 60.8 kg.Among all patients adverse events included: balloon aortic valvuloplasty (bav) that resulted in grade 2-3 stent fractures, valve-in-valve, trivial to severe pulmonary regurgitation with subsequent increased gradient measurements, coronary artery occlusion, right ventricular outflow tract (rvot) aneurysm treated with stent placement, pulmonary artery perforation and valve replacement.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: 7119548
• MDR Text Key: 94927970
• Report Number: 2025587-2017-02447
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• 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: 11/20/2017
• 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: 18 YR
• Patient Weight: 60